This document provides an overview of local drug delivery in periodontics. It begins with an introduction describing the disadvantages of non-surgical therapy and systemic administration of drugs. It then covers the history of local drug delivery. The remainder of the document discusses various carrier/vehicle systems for local drug delivery including irrigation systems, fibers, strips/films, gels, and nano/micro delivery systems. It also reviews commercially available local drug delivery systems like PerioChip which contains chlorhexidine. The document is intended as a reference for local drug delivery options and considerations in the field of periodontics.

1. 13-01-2023 1

2. Local Drug Delivery In
Periodontics
Guided by:
Dr. Monica Mahajani
Dr. Chandrahas Goud
Dr. Anup Shelke
Dr. Subodh Gaikwad
Dr. Anup Gore
Dr. Kuldeep Patil
Dr. Amrita Das
Presented by:
Dr. Chavan Sneha S.
(2nd Year PG)
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3. Contents:
• Introduction
• History
• LDD carrier / vehicle system
a. Irrigation system
b. Fibers
c. Strips & Films
d. Gel system
e. Nano / micro delivery system
• Commercially available Local drug delivery system
a. Chlorhexidine
b. Tetracycline (Actisite)
c. Doxycycline
d. Minocycline hydrochloride
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4. INTRODUCTION:
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5. • Non surgical mechanical therapy has always been the first line of
periodontal therapy
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6. Disadvantages Non surgical mechanical
therapy
Multi-rooted with
furcation
involvement
Bacteria found in
dentine tubules
and concavities
Tooth sensitivity
Due to presence of
organism deeply
penetrated into the
gingival tissues
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7. • Systemic administration and local administration are both important
methods of drug delivery.
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8. Disadvantages Systemic Antimicrobial therapy
Adverse drug
reactions
Anti-microbial
resistance
Limited use in
medically
compromised
patients
Drug interactions
Inadequate
concentration at
the site of action
Inability to be
retained locally for
a sufficient period
of time
Nausea, Vomiting
and diarrhoea
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9. History :
Dr. Max Goodson et al 1979 - used hollow tetracycline fibers
D. Steinberg et al (1990) researched chlorhexidine as a local drug
delivery
Nakagawa T et al (1991) used minocycline
Ainamo et al (1992) studied 25% metronidazole gel
Stoller et al ( 1998) studied doxycycline hyclate
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10. Ideal Requirement Of Locally Delivered Drug :
1. The drug delivery system should deliver the drug to the base of the
pocket
2. Drug must show in-vitro activity against the organisms
3. Target dose should be sufficient enough to kill the targeted organisms
also should not have any adverse effects
4. Substantivity
5. Prolonged shelf life
6. Biodegradable and Biocompatible
7. Ease of placement
8. Ready to use chairside
9. Should be economical
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11. INDICATIONS:
1. As an adjunct to scaling and root planing
2. Periodontal maintenance therapy and in shallow and
residual pockets post successful phase I therapy
3. For whom surgery is contraindicated or those who refuse
surgical treatment
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12. CONTRAINDICATION :
1. Periodontal patients with known hypersensitivity reaction to any
components of the LDD systems to be used.
2. As a replacement to scaling and root planning during initial periodontal
therapy and maintenance.
3. In pregnant or lactating patients.
4. Patients susceptible to infective endocarditis to avoid the risk of
bacteremia.
5. As a replacement for surgical periodontal therapy in cases indicated for
periodontal surgery.
6. As a replacement for systemic antibiotic therapy , where their systemic
administration is indicated.
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13. ADVANTAGES :
1. Attains a 100 fold higher concentration of antimicrobial agents in
sub-gingival sites.
2. The concentration of the drug in periodontal pocket is not affected
by the fluctuation in plasma levels.
3. The technique is suitable for agents which cannot be given
systemically, such as chlorhexidine.
4. Small doses can be administered.
5. Superinfection and drug resistance are rare.
6. Reduction in frequency of drug administration.
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14. DISADVANTAGES :
1. Difficulty in placing into the deeper parts of the pockets of the
furcation lesions.
2. Does not have any effect on adjacent or near by structures such as
tonsils , buccal mucosa etc. so may cause chances of reinfection.
3. Time consuming.
4. In presence of generalized pockets , other periodontal therapies
should be used.
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15. CLASSIFICATION :
1. Langer & Peppas ( 1981)- Based on their mechanism of action.
a. Diffusion controlled systems.
b. Chemically controlled systems.
c. Solvent activated systems.
d. Release induced by external forces.
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16. 2. Kornman(1993)
a. Reservoirs without a rate controlling system.
b. Reservoirs with a rate controlling system.
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17. 3. Rams Ans Slots (1996) - Based on application of therapy
Personally applied (patient home self care)
i. Non-sustained subgingival drug delivery
Home oral irrigation
Home oral irrigation jet tips
Traditional jet tips Oral irrigation (water pick)
Soft cone rubber tips (pick pocket)
i. Sustained subgingival drug delivery
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18. Professionally applied (in dental office)
i. Non-sustained subgingival drug delivery (professional pocket irrigation)
ii. Sustained subgingival drug delivery
Controlled release devices
Hollow fibres
Dialysis tubing
Strips
Films
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19. 4. Soskolne WA (1997) - Based on dosage form.
a. Fibers e.g. Tetracycline.
b. Films / slabs e.g. Chlorhexidine chip.
i. Non-degradable films
ii. Degradable films
c. Injectable systems e.g. Minocycline
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20. 5. Greenstein & Tonetti(2000)- Based on duration of action
a. Sustained release devices: Designed to provide drug delivery for
less than 24 hours B.
b. Controlled release devices : Designed to provide drug release that at
least exceeds 1 day or for at least 3 days following application
(Kornman1993).
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21. Classification:
R. H.R., et al. Journal of Controlled Release 307 (2019) 393–409
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22. LDD Carrier/ Vehicle System:
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23. Oral irrigation system (Dental water jet/water
flosser):
• In 1962, a Colorado dentist Gerald Moyer in collaboration with an
Engineer John Mattingly introduced the OI system as an alternative to
dental flossing to enhance patient’s oral hygiene.
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24. • Mono-jet/multi-streamed jet tips are available for supra-gingival
irrigation, and blunt cannulae with end or side ports are available for
subgingival irrigation.
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25. • Success of the locally delivered antimicrobial agents in irrigation
system depends on its depth of penetration, complexity of infection,
GCF flow, drug concentration, and available amount of drug for
sufficient duration of time at the pocket region.
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26. Fibers:
• The term fiber is derived from a Latin word ‘Fibra’ which means a
natural or a synthetic substance whose length is significantly greater
than its width.
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27. 27
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28. • Polymer :Poly(lactic acid)
• Drug : Chlorhexidine (0.5%–1.0% w/w)
• Method of formulation: Electrospinning
• Inferences : Sustained release was observed for 650 h in pre-
encapsulating chlorhexidine particles with polyelectrolyte multilayers.
The formulation demonstrated antibacterial activity against E. coli
and biocompatibility against human fibroblasts
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D. Luo, X. Zhang, S. Shahid, M.J. Cattell, D.J. Gould, G.B. Sukhorukov, Electrospun poly (lactic acid) fibers containing
novel chlorhexidine particles with sustained antibacterial activity, Biomater Sci. 5 (2017) 111–119

29. Matrix system: strips and films:
• Strips and films (SF) are polymer based thin bands of matrix system
designed to deliver the active therapeutic agents in a controlled and
sustained fashion when precisely placed in the interproximal
periodontal pocket space.
• A Japanese periodontist Noguchi, demonstrated the application of
these systems in the year 1984.
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30. 30
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31. • Polymer :2% chitosan (from crab shells), Glycerine (0.5%) as
plasticizer and Glutaraldehyde solution for cross linking
• Drug : Metformin hydrochloride
• Method of formulation: Casting method
• Inferences :The film showed sustained release of metformin over
a period of 11 days. Further metformin film showed desirable
antibacterial and bone regenerating potential in periodontitis
induced animal model.
31
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D.K. Khajuria, O.N. Patil, D. Karasik, R. Razdan, Development and evaluation of novel biodegradable chitosan based metformin
intrapocket dental film for the management of periodontitis and alveolar bone loss in a rat model, Arch. Oral Biol. 85 (2018) 120–129.

32. • Polymer :sodium alginate (4%w/v), gelatin (4%w/v),
• diammonium hydrogen phosphate calcium
• hydroxide, calcium chloride as crosslinking agent
• Drug : Tetracyclines
• Method of formulation: Solvent casting method
Inferences :The composite film demonstrated significant stability
and ease of handling. Drug release was observed for >10 days.
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K. Madhumathi, L.J. Rekha, T.S. Kumar, Tailoring antibiotic release for the treatment of periodontal infrabony defects using
bioactive gelatin-alginate/apatite nanocomposite films, J. Drug Deliv. Sci. Technol. 43 (2018), 57–64.

33. 13-01-2023 33
• Polymer :Gelatin (2.58–5.41% w/v),
• Drug :Curcumin (2 mg)
• Method of formulation: Solvent casting technique.
• Inferences :Developed film efficiently released curcumin for period of
7 days with promising effect in management of periodontitis.
S. Chauhan, M. Bansal, G. Khan, S.K. Yadav, A.K. Singh, P. Prakash, B. Mishra, Development, optimization and evaluation of
curcumin loaded biodegradable cross linked gelatin film for the effective treatment of periodontitis, Drug Dev. Ind. Pharm.
44 (2018) 1212–1221.

34. 34
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35. Gels:
• Gels are dilute, cross-linked semisolid systems in which liquid
particles/ the active drug molecules are uniformly dispersed in a solid
medium that exhibits no flow when in the steady-state.
• Gels get the maximum credit in the general dental practice for being
used as a carrier system to deliver therapeutic agents in a wide range
of oral diseases such as oral ulcers, denture stomatitis and
desquamative gingival lesions.
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36. Polymer :Water-soluble: Chitosan (2% (w/v) in distilled water), base chitosan
(2% concentration in dilute lactic acid (1% v/v)
Drug :Atorvastatin (2% (w/v)) in polyethylene glycol 400 (PEG 400).
Method of formulation:Conventional gel followed by acetylation
Inferences :The chitosan-based atorvastatin gel displayed desirable viscosity
and
syringe ability properties. It provided adequate bio-adhesion to hold
the system at the application site. The release of the drug was found to
be slower as compared to that atorvastatin gel prepared in PEG 400.
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A.I. Özdoğan, G. Akca, S. Şenel, Development and in vitro evaluation of chitosan based system for local delivery of
atorvastatin for treatment of periodontitis, Eur. J. Pharm. Sci. 124 (2018) 208–216.

37. • Polymer :
Cinnamon oil (oil phase) tween 80 and Carbitol
(surfactant- cosurfactant mixture), poloxamer
407 (23% w/v)
Drug :Quercetin (125 μg/200 μL)
Method of formulation:Thermoreversible gel
Inferences :Quercetin loaded nano-emulgel displayed complete release
of
quercetin over 6 h.
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G. Aithal, U. Nayak, C. Mehta, R. Narayan, P. Gopalkrishna, S. Pandiyan, S. Garg, Localized in situ nanoemulgel drug
delivery system of quercetin for periodontitis: development and computational simulations, Molecules 23 (2018) 1363

38. Nano/Micro delivery system:
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39. Nanoparticulate drug delivery (NP) system:
• In the recent years, nanoparticles (dimension less ≤100 nm) are
gaining extensive attention in the biomedical field owing to their
ability to accurately deliver the active therapeutic agents to the target
site.
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40. • Polymer : Nanoparticles Silver nitrate (AgNO3) (5 mM) in collagen
• Drug: Silver nanoparticles suspensions in collagen
• Method of formulation: Simple reduction method
• Inferences : Synthesized nanoparticles demonstrated dose dependent
antibacterial activity against periodontal pathogens and were found
to be biocompatible against human gingival fibroblasts
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O. Craciunescu, A.M. Seciu, V.S. Manoiu, M. Trif, M. Moisei, A.I. Nicu, O. Zarnescu, Biosynthesis of silver nanoparticles in
collagen gel improves their medical use in periodontitis treatment, Part. Sci. Technol. 12 (2018) 1–7.

41. • Polymer : PLGA copolymers and Chitosan (1% w/w)
• Drug: Metronidazole or Nphenacylthiazolium bromide
• Method of formulation: Oil- in- water emulsion solvent evaporation
• Inferences : Formulation demonstrated initial rapid drug release at pH
5.5 whereas the drug was completely released in 7 days. It reduced
subgingival inflammation in experimental periodontitis in rats.
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J.H. Lin, F. Feng, M.C. Yu, C.H. Wang, P.C. Chang, Modulation of periodontitis progression using Ph-responsive nanosphere
encapsulating metronidazole or Nphenacylthialzolium bromide, J. Periodontal Res. 53 (2018) 22–28.

42. Microparticulate system
• Microparticles are solid spherical polymeric structures with a
diameter range of 1–1000 μm designed to contain active therapeutic
agents, dispersed uniformly throughout the polymeric matrix.
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43. • Polymer :Dextran sulfate (DS), CaCl2 Minocycline (2 mg/mL) Ion
pairing-complexation/ The ion pairing/complexation of minocycline,
Ca2+, and sulfonate/ sulfate-bearing biopolymers, achieved sustained
release for 9 days.
• Drug :Minocycline (2 mg/mL)
• Method of formulation:on pairing-complexation
Inferences : The ion pairing/complexation of minocycline, Ca2+, and
sulfonate/ sulfate-bearing biopolymers, achieved sustained release for
9 days. The antimicrobial activity was effective against Aa and Sm.
43
13-01-2023 L. Wu, W. Chen, F. Li, B.R. Morrow, F. Garcia-Godoy, L. Hong, Sustained release of minocycline from minocycline-
calcium-dextran sulfate complex microparticles for periodontitis treatment, J. Pharm. Sci. 107 (2018) 3134–3142

44. COMMERCIALLY AVAILABLE
LOCAL DRUG DELIVERY SYSTEM
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45. PerioChip 2.5mg
(Chlorhexidine gluconate)
• PerioChip (chlorhexidine gluconate) is a small, orange-brown, rectangular
chip (rounded at one end) for insertion into periodontal pockets.
• Each PerioChip weighs approximately 6.9 mg
Composition:
2.5 mg of chlorhexidine gluconate in a biodegradable matrix of hydrolyzed gelatin
(cross-linked with glutaraldehyde).
glycerin and purified water.
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46. COMMERCIAL AVAILABILITY:
• Each chip is individually packed in a separate compartment of an
aluminum blister pack.
• Store at 20° - 25°C with excursions permitted to 15° - 30° C (59° -
86°F).
• It is manufactured by: DEXCEL PHARMA TECHNOLOGIES LTD, Israel.
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47. DOSAGE AND ADMINISTRATION
• One PerioChip is inserted into a periodontal
pocket with probing pocket depth (PD) 5 mm or
greater.
• Treatment is recommended to be administered
once every three months in pockets with PD
remaining 5 mm or greater.
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48. Procedure:
Periochip dimension:
5*4*0.3mm thickness
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49. • If dislodgement occurs within 48 hours after placement, a new
PerioChip should be inserted.
• If dislodgement occurs more than 48 hours after placement, the
dentist should not replace the PerioChip, but reevaluate the patient
at 3 months and insert a new PerioChip if the pocket depth has not
reduced to < 5mm.
• If dislodgement occurs 7 days or more after placement, the dentist
should consider the subject to have received a full course of
treatment.
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50. MECHANISM OF ACTION
• PerioChip releases chlorhexidine in vitro in a biphasic manner, initially
releasing approximately 40% of the chlorhexidine within the first 24
hours and then releasing the remaining chlorhexidine in an almost
linear fashion for 7-10 days.
• This release profile may be explained as an initial burst effect,
dependent on diffusion of chlorhexidine from the chip, followed by a
further release of chlorhexidine as a result of enzymatic degradation.
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51. INDICATIONS AND USAGE
• PerioChip is indicated as an adjunct to scaling and root planing
procedures for reduction of pocket depth in patients with
periodontitis.
• PerioChip may be used as a part of a periodontal maintenance
program, which includes good oral hygiene and scaling and root
planing.
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52. CONTRAINDICATIONS
• PerioChip should not be used in any patient who has a known
sensitivity to chlorhexidine.
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53. INSTRUCTIONS FOR PATIENTS
• Patients should avoid brushing for minimum 3 days & dental floss at
the site of PerioChip insertion for 10 days after placement.
• Afterwards, all other oral hygiene measures may be continued as
usual.
• No restrictions regarding dietary habits are needed. They have to be
cautious and gentle when eating from treated side.
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54. ADVERSE REACTIONS
• The most frequently observed adverse event was toothache.
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55. Chlorhexidine-Based Products
PerioCol-CG
• PerioCol-CG is a small, 10-mg chip (4 × 5 × 0.25–
0.32 mm) designed as a collagen matrix into which
chlorhexidine gluconate (2.5 mg) is incorporated as
its active ingredient.
• The chip is designed for insertion into the
periodontal pocket and resorbs after 30 days, but
its coronal edge degrades within 10 days.
• It releases chlorhexidine in vitro at a rate of
approximately 40% to 45% in the first 24 hours,
followed by a linear release for 7 to 8 days, and it
has a shelf life of 2 years.
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56. Chlo-Site
• Chlo-Site is a xanthan gel, consisting of a saccharide
polymer as a three-dimensional mesh containing 1.5%
chlorhexidine in 0.5 mL of gel, which is injected into
the periodontal pocket.
• The gel contains two types of chlorhexidine:
a slow-release chlorhexidine digluconate (0.5%) and
rapid-release chlorhexidine dihydrochloride (1.0%).
• The gel is retained within the pocket and is not easily
dislodged by the GCF or saliva.
• The gel product is sterilized by gamma radiation at 2.5
Mrad and is individually packed for delivery in 0.25-mL
prefilled syringes fitted with a blunt side-exit needle.
• The gel disappears from the pocket in 10 to 30 days.
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57. Tetracycline-Based Products
PerioCol-TC
• PerioCol-TC vial contains fish type I collagen (approximately 25 mg)
impregnated with approximately 2.0 mg of tetracycline
hydrochloride, which is sterilized by gamma radiation.
• PerioCol-TC releases tetracycline in vitro for 8 to 10 days.
• PerioCol-TC is indicated for the treatment of adult periodontitis as
an adjunct to SRP for pockets more than 5 mm deep, and it can be
administered every 3 months.
• The fibers are moistened with saline and placed into the
periodontal pocket to the depth of the pocket base; they are
biodegradable and do not have to be removed.
• PerioCol-TC is stored in a dry place between 5° C (41° F) and 25° C
(77° F) and has a shelf life of 2 years with proper storage.
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58. Periodontal Plus AB
• Periodontal Plus AB is a bioresorbable tetracycline fiber.
• It is 25 mg of pure fibrillar collagen evenly impregnated with
approximately 2 mg of tetracycline hydrochloride.
• The fiber biodegrades in the periodontal pocket within 7
days.
• The fiber should be retained with a periodontal dressing or
covered with a dental adhesive for 10 days.
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59. Actisite
(25%w/v tetracycline HCl)
• Generic name: tetracycline
Drug class: Tetracyclines
• Actisite (25%w/v tetracycline Hcl) fiber
• The Actisite tetracycline fibres have been approved both by the
United States Food and DrugAdministration (FDA) and by the
European Union's regulatory agencies.
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60. Adverse effects:
• Discomfort
• Local erythema
• Occasional systemic reaction
• Oral candidiasis
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61. Doxycycline-Based Products
Ligosan Slow Release
• Ligosan Slow Release is a 14% (w/w), resorbable doxycycline gel for
periodontal application provided in a laminate pouch and stored
under refrigeration.
• It contains 1, 2, 4, 8, 10, or 16 single-application cylinder cartridges,
each containing 260 mg of Ligosan Slow Release.
• The product is used by inserting the cartridge into the caulking gun,
opening the spray nozzle, and then discharging the gel to the bottom
of the pocket.
• Mechanical hygiene in the area should be avoided for 7 days
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62. 62
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63. ATRIDOX (Doxycycline hyclate) 10%
• ATRIDOX product is a subgingival controlled-release product composed of
a two syringe mixing system.
• Syringe A contains 450 mg of the ATRIGEL Delivery System, which is a
bioabsorbable, flowable polymeric formulation composed of 36.7%
poly(DLlactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP).
• Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5
mg doxycycline.
• The constituted product is a pale yellow to yellow viscous liquid with a
concentration of 10% of doxycycline hyclate.
• Upon contact with the crevicular fluid, the liquid product solidifies and
then allows for controlled release of drug for a period of 7 days.
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64. 13-01-2023 64

65. COMMERCIAL AVAILABILTY:
• The final blended product is 500 mg of formulation containing 50
mg of doxycycline hyclate (doxycycline hyclate, 10%).
• Rx Only ATRIDOX is available as a tray or pouch containing a
doxycycline hyclate syringe (50 mg), an ATRIGEL Delivery System
syringe (450 mg), and a blunt cannula.
• The pouched product is available in a box of six, a box of two, or a
professional sample pouch.
• The trayed product is available in a box of six, a box of four, or a
professional sample box of two.
• Each ATRIDOX syringe system is intended for use in only one
patient.
• Storage Conditions: Store at 2° - 30°C (36° - 86°F).
• Manufactured by TOLMAR Inc
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66. • MECHANISM OF ACTION:
• Doxycycline is a broad-spectrum semisynthetic tetracycline.
• Doxycycline is bacteriostatic, inhibiting bacterial protein synthesis.
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67. INDICATIONS AND USAGE:
• ATRIDOX is indicated for use in the treatment of chronic adult
periodontitis for a gain in clinical attachment, reduction in probing
depth, and reduction in bleeding on probing.
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68. CONTRAINDICATIONS:
• ATRIDOX should not be used in patients who are hypersensitive to
doxycycline or any other drug in the tetracycline class.
• Pregnancy: Teratogenic Effects
• Nursing Mothers
• Enamel hypoplasia
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69. • DOSAGE AND ADMINISTRATION:
ATRIDOX is a variable dose product dependent on the size, shape, and
number of pockets being treated.
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70. Preparation for Use:
• If refrigerated, remove the product from refrigeration at least 15 minutes prior to
mixing.
• Couple Syringe A (liquid delivery system) and Syringe B (drug powder).
• Complete 100 mixing cycles at a pace of one cycle per second using brisk strokes.
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71. • If necessary, the coupled syringes can be stored at room temperature
for a maximum of three days. Some of the Atridox systems are
packaged in resealable pouches that can be used for this purpose. If
the Atridox system is packaged in a tray, use an airtight container.
• After storage, perform an additional ten mixing cycles just prior to
use.
• Uncouple the two syringes and attach one of the provided cannulae
to Syringe A.
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72. Product Administration:
• ATRIDOX does not require local anesthesia for placement.
• Bend the cannula to resemble a periodontal probe and explore the
periodontal pocket in a manner similar to periodontal probing.
• Keeping the cannula tip near the base of the pocket, express the
product into the pocket until the formulation reaches the top of the
gingival margin.
• Withdraw the cannula tip from the pocket.
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73. • In order to separate the tip from the formulation, turn the tip of the
cannula towards the tooth, press the tip against the tooth surface,
and pinch the string of formulation from the tip of the cannula.
Variations on this technique may be needed to achieve separation
between ATRIDOX and cannula.
• Cover the pockets containing ATRIDOX with either Coe-Pak™
periodontal dressing or a cyanoacrylate dental adhesive.
• Application of ATRIDOX may be repeated four months after initial
treatment.
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74. • PATIENT INSTRUCTIONS:
Mechanical oral hygiene procedures (i.e., tooth brushing, flossing)
should be avoided on any treated areas for 7 days.
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75. PRECAUTIONS:
• As with other antibiotic preparations, ATRIDOX therapy may result in
overgrowth of nonsusceptible organisms, including fungi. The effects
of prolonged treatment, greater than six months, have not been
studied.
• ATRIDOX should be used with caution in patients with a history of or
predisposition to oral candidiasis.
• Any tetracycline drug usually associated with candidiasis.
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76. ADVERSE REACTIONS:
• Sensitivity
• Toothache
• Swelling/ inflammation
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77. ARESTIN
(Minocycline hydrochloride)
Microspheres, 1 mg
• ARESTIN (minocycline hydrochloride) Microspheres is a
subgingival controlled‐release product containing the antibiotic
minocycline hydrochloride incorporated into a bioresorbable
polymer, Poly (glycolide‐co‐dl‐lactide) or PGLA, for professional
subgingival administration into periodontal pockets.
• Each unit‐dose cartridge delivers minocycline hydrochloride
equivalent to 1 mg of minocycline free base.
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78. COMMERCIAL AVAILABILITY:
• Rx only ARESTIN (minocycline hydrochloride) Microspheres, 1 mg is
supplied as follows:
1 unit‐dose cartridge with desiccant in a heat‐sealed, foil‐laminated pouch.
12 unit‐dose cartridges in 1 tray with desiccant in a heat‐sealed,
foil‐laminated, resealable pouch. There are 2 pouches in each box
• Each unit‐dose cartridge contains the product identifier "OP‐1."
• Storage Conditions: Store at 20° to 25°C (68° to 77°F)/60% RH: excursions
permitted to 15° to 30°C (59° to 86°F). Avoid exposure to excessive heat.
• Manufactured for OraPharma, Inc. 5 Walnut Grove DriveHorsham, PA
19044.
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79. MECHANISM OF ACTION:
• Minocycline belongs to the tetracycline class of antibiotics and has a
broad spectrum of activity.
• Its bacteriostatic, antimicrobial activity results from the inhibition of
protein biosynthesis.
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80. • INDICATIONS AND USE:
• ARESTIN is indicated as an adjunct to scaling and root planing
procedures for reduction of pocket depth in patients with adult
periodontitis.
• ARESTIN may be used as part of a periodontal maintenance program
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81. CONTRAINDICATIONS:
• ARESTIN should not be used in any patient who has a known
sensitivity to minocycline or tetracyclines.
• Pregnancy: Teratogenic Effects
• Nursing Mothers
• Enamel hypoplasia
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82. DOSAGE AND ADMINISTRATION:
• ARESTIN is provided as a dry powder, packaged in a unit‐dose
cartridge with a deformable tip, which is inserted into a
spring‐loaded cartridge handle mechanism to administer the
product.
• The oral health care professional removes the disposable cartridge
from its pouch and connects the cartridge to the handle
mechanism.
• ARESTIN is a variable dose product, dependent on the size, shape,
and number of pockets being treated.
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83. • Professional subgingival administration is accomplished by inserting
the unit‐dose cartridge to the base of the periodontal pocket and
then pressing the thumb ring in the handle mechanism to expel the
powder while gradually withdrawing the tip from the base of the
pocket.
• ARESTIN does not have to be removed, as it is bioresorbable, nor is an
adhesive or dressing required.
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84. • Patients should be advised that although some mild to moderate
sensitivity is expected during the first week after SRP and
administration of ARESTIN , they should notify the dentist promptly if
pain, swelling, or other problems occur.
• Patients should be notified to inform the dentist if itching, swelling,
rash, papules, reddening, difficulty breathing, or other signs and
symptoms of possible hypersensitivity occur.
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85. PRECAUTIONS:
• As with other antibiotic preparations, ARESTIN therapy may result in
overgrowth of nonsusceptible organisms, including fungi. The effects
of prolonged treatment, greater than six months, have not been
studied.
• ARESTIN should be used with caution in patients with a history of or
predisposition to oral candidiasis.
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86. ADVERSE REACTIONS:
• Hypersensitivity Reactions
• Autoimmune Syndromes
• Toothache
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