Raphael F de Souza, DDS, PhD University of Sao
Paulo, Brazil
McGill University , Montréal, Canada· Division
of Oral Health and Society.
Experience in the coordination of randomized
clinical trials as well as systematic reviews.

complete denture, edentulous mouth, minimally invasive
surgical procedures, patient outcome assessment, patient satisfaction, quality
of life
ClinicalTrials.gov Identifier: NCT01411683
© International & American Associations for Dental Research

P: …???
(completely Edent. P.)

(OHRQoL, Patient satisfaction and
Implant survival)

Allocation: Randomized
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

PICOS
P: …??? (completely Edent.)
I: Mini Implants supported O.D.
C: Standard Implants O.D.
O: …??? OHRQoL, Patient satisfaction and
Implant survival
S: RCT

Groups:
2 or 4 mini-implants with standard implants

120 edentulous men and women
Mean age, 59.5± 8.5 y
Follow up until 12 month

They tested the null hypothesis that patient
perceptions and clinical parameters would be
similar for the 3 treatments.

Inclusion
• Complete edentulism;
• Request of implant stabilization of
the existing lower conventional
denture;
• Clinically acceptable maxillary and
mandibular complete dentures;
• Adequate space in the anterior
mandible for the placement of four
mini implants and two conventional
implants (regular diameter);
• Ability to maintain adequate oral
hygiene and clean dentures;
• Systemic health status that permits
minor surgical procedures;
• Adequate understanding of written
and spoken Portuguese;
• Capacity of giving written informed
consent.
Exclusion
• Lack of minimum vertical
mandibular bone height of 11mm in
the interforaminal region;
• Acute or chronic symptoms of
parafunctional disorders;
• History of radiation therapy to the
orofacial region;
• Specific conditions that may
jeopardize the treatment, i.e.
alcoholism and smoking;
• Severe/serious illness that requires
frequent hospitalization;
• Impaired cognitive function;
• Impossibility to return for
evaluations/study recalls

OHIP-EDENT
better
higher
higher

Pairwise comparisons
89%
(82%).
99%.
BOCF
14

peri-implant health parameters.
Groups 1 and 2 presented a significantly lower plaque index
compared with group 3 at the time of overdenture insertion
and following 6 and 12 mo.
The occurrence of other prosthetic and peri-implant
complications was similar among groups

2 standard
2 mni
4 mini
-
OHIP-EDENT
OHIP-EDENT
-
-
patient
satisfaction and
-
-
Masticator ability
survival rate
99%
82%
89%

A. RANDOM SEQUENCE GENERATION
Selection bias (biased allocation to interventions) due to inadequate generation of a
randomised sequence.

Randomization
Low risk
selec. bias

B. ALLOCATION CONCEALMENT
Selection bias (biased allocation to interventions) due to inadequate concealment
of allocations prior to assignment.

Sequence
genatieron
Low risk
Allocation
Concealment
Low risk

C. SELECTIVE REPORTING
Reporting bias due to selective outcome reporting.

C. SELECTIVE REPORTING
Reporting bias due to selective outcome reporting.

C. SELECTIVE REPORTING
Reporting bias due to selective outcome reporting.

Randomizatio
n
Low
risk
Allocation
Concealment
Low risk
Selective
reporting
Low Risk

D. BLINDING OF PARTICIPANTS
Performance bias due to knowledge of the allocated interventions by participants and
personnel during the study.

Randomizatio
n
Low
risk
Allocation
Concealment
Low risk
Selective
reporting
Low Risk
Binding of
participant
Low Risk

E. BLINDING OF OUTCOME ASSESSMENT
Detection bias due to knowledge of the allocated interventions by outcome assessors.

Selection basd
Low risk
Allocation
Concealment
Low risk
Selective
reporting
Low Risk
Binding of
participant
High Risk
Blinding of
assessment
High Risk

F. INCOMPLETE OUTCOME DATA
Attrition bias due to amount, nature or handling of incomplete outcome data.

Selection bias
Low risk
Allocation
Concealment
Low risk
Selective
reporting
Low Risk
Binding of
participant
performance
Low Risk
Blinding of
assessment
Detection
High Risk
Attrition
bias
Low risk

F. Other bias
Bias due to problems not covered elsewhere in the table

Selection bias
Low risk
Allocation
Concealment
Low risk
Selective
reporting
Low Risk
Binding of
participant
performance
Low Risk
Blinding of
assessment
Detection
High Risk
Attrition
bias
Low risk
Other bias
Low risk

Low
Risk
Selection bias
Low risk
Allocation
Concealment
Low risk
Selective
reporting
Low Risk
Binding of
participant
performance
Low Risk
Blinding of
assessment
Detection
High Risk
Attrition
bias
Low risk
Other bias
Low risk

Mini-implant-retained overdentures can achieve results
at least comparable with the standard of care for
edentulism, according to the patient perspectives.
The insertion of 4 mini-implants results in superior
OHRQoL and patient satisfaction as compared with 2
mini- or standard implants.
A major issue for using mini-implants, however, is their
lower implant survival rate compared with standard
fixtures.