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Mandibular Overdentures Retained by Conventional or Mini Implants

This study is currently recruiting participants.
Verified January 2012 by University of Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Raphael Freitas de Souza, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01411683
First received: August 5, 2011
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Edentulous Mouth
Edentulous Jaw
 Device: Implant-retained mandibular overdenture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Denture satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To be assessed by specific questionnaires

  • Oral health-related quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To be assessed by means of the Brazilian version of the OHIP-EDENT.


Secondary Outcome Measures:
  • Post-surgical discomfort [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.

  • Success rate of implant-retained mandibular overdentures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Survival of implant-retained overdentures.

  • Denture quality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Functional aspects of mandibular overdentures, as assessed by a dentist.

  • Treatment costs [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 mini dental implants
Retention of an overdenture by means of 4 mini implants.
 Device: Implant-retained mandibular overdenture
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.
Other Name: - Mini-implant overdenture.
Experimental: 2 mini dental implants
Retention of an overdenture by means of 2 mini implants.
 Device: Implant-retained mandibular overdenture
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.
Other Name: - Mini-implant overdenture.
Active Comparator: 2 conventional dental implants
Retention of an overdenture by means of 2 conventional implants associated to ball attachments.
 Device: Implant-retained mandibular overdenture
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.
Other Name: - Mini-implant overdenture.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411683

Contacts
Contact: Viviane C. Oliveira, BSc, MSc +55-16-36024800 vivianecassia@usp.br
Contact: Maria Paula Della Vecchia, DDS +55-16-36024800 paulavecchia@yahoo.com.br

Locations
Brazil
Ribeirão Preto Dental School Recruiting
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sub-Investigator: Claudia H Silva-Lovato, DDS, PhD            
Sub-Investigator: Helena FO Paranhos, DDS, PhD            
Sub-Investigator: Valdir A Muglia, DDS, PhD            
Principal Investigator: Raphael F Souza, DDS, PhD            
Principal Investigator: Rubens F Albuquerque Jr, DDS, PhD            
Sub-Investigator: Andrea C dos Reis, DDS, PhD            
Sub-Investigator: Sergio LS de Souza, DDS, PhD            
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Raphael F de Souza, DDS, PhD University of Sao Paulo
  More Information

Additional Information:
Institutional page of the Ribeirão Preto Dental School (research site)  This link exits the ClinicalTrials.gov site
Principal Investigator´s CV (RF de Souza)  This link exits the ClinicalTrials.gov site
Principal Investigator´s CV (RF Albuquerque Jr)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Raphael Freitas de Souza, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01411683     History of Changes
Other Study ID Numbers: FORP-PT-004, 2011.1.197.58.3, 2011/00688-7
Study First Received: August 5, 2011
Last Updated: January 25, 2012
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
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

Additional relevant MeSH terms:
Jaw, Edentulous
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
 Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on May 23, 2013