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Mandibular Overdentures Retained by Conventional or Mini Implants

Primary Purpose

Edentulous Mouth, Edentulous Jaw

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Implant-retained mandibular overdenture
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Mouth focused on measuring Cost estimates, Complete Denture, Dental Economics, Dental Implants, Dental Prosthesis, Implant-Supported, Denture Retention, Edentulous, Edentulism, Mini dental implant, Oral Health-Related Quality of Life, Overdenture, Patient Acceptance of Health Care, Quality of Health Care, Quality of Life, Patient Satisfaction

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • Ribeirão Preto Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

4 mini dental implants

2 mini dental implants

2 conventional dental implants

Arm Description

Retention of an overdenture by means of 4 mini implants.

Retention of an overdenture by means of 2 mini implants.

Retention of an overdenture by means of 2 conventional implants associated to ball attachments.

Outcomes

Primary Outcome Measures

Denture satisfaction
To be assessed by specific questionnaires
Oral health-related quality of life
To be assessed by means of the Brazilian version of the OHIP-EDENT.

Secondary Outcome Measures

Post-surgical discomfort
Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.
Success rate of implant-retained mandibular overdentures
Survival of implant-retained overdentures.
Denture quality
Functional aspects of mandibular overdentures, as assessed by a dentist.
Treatment costs
This outcome will be measured by means of specific forms, according to 2 components: Direct costs: cost of labor, materials, radiographs and medications; Indirect costs: patient's time and transportation expenses.

Full Information

First Posted
August 5, 2011
Last Updated
April 13, 2017
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01411683
Brief Title
Mandibular Overdentures Retained by Conventional or Mini Implants
Official Title
Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth, Edentulous Jaw
Keywords
Cost estimates, Complete Denture, Dental Economics, Dental Implants, Dental Prosthesis, Implant-Supported, Denture Retention, Edentulous, Edentulism, Mini dental implant, Oral Health-Related Quality of Life, Overdenture, Patient Acceptance of Health Care, Quality of Health Care, Quality of Life, Patient Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 mini dental implants
Arm Type
Experimental
Arm Description
Retention of an overdenture by means of 4 mini implants.
Arm Title
2 mini dental implants
Arm Type
Experimental
Arm Description
Retention of an overdenture by means of 2 mini implants.
Arm Title
2 conventional dental implants
Arm Type
Active Comparator
Arm Description
Retention of an overdenture by means of 2 conventional implants associated to ball attachments.
Intervention Type
Device
Intervention Name(s)
Implant-retained mandibular overdenture
Other Intervention Name(s)
- Mini-implant overdenture.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Denture satisfaction
Description
To be assessed by specific questionnaires
Time Frame
2 years
Title
Oral health-related quality of life
Description
To be assessed by means of the Brazilian version of the OHIP-EDENT.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Post-surgical discomfort
Description
Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.
Time Frame
7 days
Title
Success rate of implant-retained mandibular overdentures
Description
Survival of implant-retained overdentures.
Time Frame
2 years
Title
Denture quality
Description
Functional aspects of mandibular overdentures, as assessed by a dentist.
Time Frame
2 years
Title
Treatment costs
Description
This outcome will be measured by means of specific forms, according to 2 components: Direct costs: cost of labor, materials, radiographs and medications; Indirect costs: patient's time and transportation expenses.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael F de Souza, DDS, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribeirão Preto Dental School
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27479342
Citation
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.
Results Reference
result
PubMed Identifier
25765784
Citation
Ribeiro 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.
Results Reference
result
PubMed Identifier
26294416
Citation
de 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.
Results Reference
result
PubMed Identifier
24975725
Citation
dos 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.
Results Reference
result
PubMed Identifier
30938654
Citation
Della 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.
Results Reference
derived
Links:
URL
http://www.forp.usp.br
Description
Institutional page of the Ribeirão Preto Dental School (research site)
URL
http://lattes.cnpq.br/7092555880664311
Description
Principal Investigator´s CV (RF de Souza)
URL
http://lattes.cnpq.br/5953029548378417
Description
Principal Investigator´s CV (RF Albuquerque Jr)

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Mandibular Overdentures Retained by Conventional or Mini Implants

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