Edentulous Jaw, Edentulous Mouth
Conditions
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
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Denture satisfaction | 2 years | To be assessed by specific questionnaires |
| Oral health-related quality of life | 2 years | To be assessed by means of the Brazilian version of the OHIP-EDENT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical discomfort | 7 days | Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire. |
| Success rate of implant-retained mandibular overdentures | 2 years | Survival of implant-retained overdentures. |
| 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. |
Countries
Brazil