Mandibular Overdentures Retained by Conventional or Mini Implants

Not Applicable

Completed

• Conditions: Edentulous Jaw; Edentulous Mouth
• Interventions: Device: Implant-retained mandibular overdenture

• Registration Number: NCT01411683
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Study Start: 2011-09
• Primary Completion: 2014-12
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 mini dental implants	Implant-retained mandibular overdenture	Retention of an overdenture by means of 4 mini implants.
2 mini dental implants	Implant-retained mandibular overdenture	Retention of an overdenture by means of 2 mini implants.
2 conventional dental implants	Implant-retained mandibular overdenture	Retention of an overdenture by means of 2 conventional implants associated to ball attachments.

Primary Outcome Measures

Name	Time	Method
Oral health-related quality of life	2 years	To be assessed by means of the Brazilian version of the OHIP-EDENT.
Denture satisfaction	2 years	To be assessed by specific questionnaires

Secondary Outcome Measures

Name	Time	Method
Success rate of implant-retained mandibular overdentures	2 years	Survival of implant-retained overdentures.
Post-surgical discomfort	7 days	Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.
Denture quality	2 years	Functional aspects of mandibular overdentures, as assessed by a dentist.
Treatment costs	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.

Trial Locations

Locations (1)

Ribeirão Preto Dental School; 🇧🇷 Ribeirão Preto, São Paulo, Brazil