Mandibular Overdentures Retained by Conventional or Mini Implants

Study Overview
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Brief Summary
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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.

Official Title
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Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial

Conditions
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Edentulous Mouth, Edentulous Jaw

Intervention / Treatment
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* Device: Implant-retained mandibular overdenture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 mini dental implants<br>Retention of an overdenture by means of 4 mini implants. | Device: Implant-retained mandibular overdenture<br>* 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.<br>* Other names: - Mini-implant overdenture.;|
| Experimental: 2 mini dental implants<br>Retention of an overdenture by means of 2 mini implants. | Device: Implant-retained mandibular overdenture<br>* 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.<br>* Other names: - Mini-implant overdenture.;|
| Active Comparator: 2 conventional dental implants<br>Retention of an overdenture by means of 2 conventional implants associated to ball attachments. | Device: Implant-retained mandibular overdenture<br>* 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.<br>* Other names: - Mini-implant overdenture.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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