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Mandibular Overdentures Retained by Conventional or Mini Implants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411683
First Posted: August 8, 2011
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Raphael Freitas de Souza, University of Sao Paulo
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Raphael Freitas de Souza, University of Sao Paulo:

Primary Outcome Measures:
  • Denture satisfaction [ Time Frame: 2 years ]
    To be assessed by specific questionnaires

  • Oral health-related quality of life [ Time Frame: 2 years ]
    To be assessed by means of the Brazilian version of the OHIP-EDENT.


Secondary Outcome Measures:
  • Post-surgical discomfort [ Time Frame: 7 days ]
    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 ]
    Survival of implant-retained overdentures.

  • Denture quality [ Time Frame: 2 years ]
    Functional aspects of mandibular overdentures, as assessed by a dentist.

  • Treatment costs [ Time Frame: 2 years ]

    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.


Enrollment: 120
Study Start Date: September 2011
Study Completion Date: April 2017
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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411683


Locations
Brazil
Ribeirão Preto Dental School
Ribeirão Preto, São Paulo, Brazil, 14040-904
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:
Publications:
Responsible Party: Raphael Freitas de Souza, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01411683     History of Changes
Other Study ID Numbers: FORP-PT-004
2011.1.197.58.3 ( Other Identifier: Institutional Review Board (FORP-USP) )
2011/00688-7 ( Other Grant/Funding Number: FAPESP )
First Submitted: August 5, 2011
First Posted: August 8, 2011
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Raphael Freitas de Souza, 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:
Mouth, Edentulous
Jaw, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases


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