Mandibular Overdentures Retained by Conventional or Mini Implants
3 other identifiers
interventional
120
1 country
1
Brief Summary
This study aims to compare mandibular overdentures retained either by mini or standard size implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and oral health-related quality of life. We will also evaluate post surgical discomfort, the success rate of prostheses and implants in the long term, denture quality and costs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 17, 2017
April 1, 2017
3.3 years
August 5, 2011
April 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Denture satisfaction
To be assessed by specific questionnaires
2 years
Oral health-related quality of life
To be assessed by means of the Brazilian version of the OHIP-EDENT.
2 years
Secondary Outcomes (4)
Post-surgical discomfort
7 days
Success rate of implant-retained mandibular overdentures
2 years
Denture quality
2 years
Treatment costs
2 years
Study Arms (3)
4 mini dental implants
EXPERIMENTALRetention of an overdenture by means of 4 mini implants.
2 mini dental implants
EXPERIMENTALRetention of an overdenture by means of 2 mini implants.
2 conventional dental implants
ACTIVE COMPARATORRetention of an overdenture by means of 2 conventional implants associated to ball attachments.
Interventions
Insertion of implants in the lower arch in order to retain existing complete dentures. Tested implants are approved by the Brazilian National Health Surveillance Agency for clinical use.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ribeirão Preto Dental School
Ribeirão Preto, São Paulo, 14040-904, Brazil
Related Publications (5)
Chaves CA, Souza RF, Cunha TR, Vecchia MP, Ribeiro AB, Bruniera JF, Silva-Sousa YT. Preliminary In Vitro Study on O-Ring Wear in Mini-Implant-Retained Overdentures. Int J Prosthodont. 2016 Jul-Aug;29(4):357-9. doi: 10.11607/ijp.4677.
PMID: 27479342RESULTRibeiro AB, Della Vecchia MP, Cunha TR, Sorgini DB, Dos Reis AC, Muglia VA, de Albuquerque RF Jr, de Souza RF. Short-term post-operative pain and discomfort following insertion of mini-implants for retaining mandibular overdentures: a randomized controlled trial. J Oral Rehabil. 2015 Aug;42(8):605-14. doi: 10.1111/joor.12287. Epub 2015 Mar 13.
PMID: 25765784RESULTde Souza RF, Ribeiro AB, Della Vecchia MP, Costa L, Cunha TR, Reis AC, Albuquerque RF Jr. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial. J Dent Res. 2015 Oct;94(10):1376-84. doi: 10.1177/0022034515601959. Epub 2015 Aug 20.
PMID: 26294416RESULTdos Reis AC, Leon JE, Ribeiro AB, Della Vecchia MP, Cunha TR, de Souza RF. Traumatic ulcerative granuloma with stromal eosinophilia around mini dental implants without the protection of a denture base. J Prosthodont. 2015 Jan;24(1):83-6. doi: 10.1111/jopr.12184. Epub 2014 Jun 27.
PMID: 24975725RESULTDella Vecchia MP, Leles CR, Cunha TR, Ribeiro AB, Sorgini DB, Muglia VA, Reis AC, Albuquerque RF Jr, de Souza RF. Mini-Implants for Mandibular Overdentures: Cost-Effectiveness Analysis alongside a Randomized Trial. JDR Clin Trans Res. 2018 Jan;3(1):47-56. doi: 10.1177/2380084417741446. Epub 2017 Nov 20.
PMID: 30938654DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raphael F de Souza, DDS, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 8, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2014
Study Completion
April 1, 2017
Last Updated
April 17, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share