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Mandibular Overdentures Retained by Conventional or Mini Implants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01411683
Enrollment
120
Registered
2011-08-08
Start date
2011-09-30
Completion date
2017-04-30
Last updated
2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Jaw, Edentulous Mouth

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

DEVICEImplant-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.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Denture satisfaction2 yearsTo be assessed by specific questionnaires
Oral health-related quality of life2 yearsTo be assessed by means of the Brazilian version of the OHIP-EDENT.

Secondary

MeasureTime frameDescription
Post-surgical discomfort7 daysPain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.
Success rate of implant-retained mandibular overdentures2 yearsSurvival of implant-retained overdentures.
Denture quality2 yearsFunctional aspects of mandibular overdentures, as assessed by a dentist.
Treatment costs2 yearsThis 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026