Mandibular Overdentures Retained by Conventional or Mini Implants

University of Sao Paulo

Status: Completed

Conditions: Edentulous Jaw; Edentulous Mouth

Treatments: Device: Implant-retained mandibular overdenture

Study type: Interventional

Funder types: Other

Identifiers

NCT01411683

2011/00688-7 (Other Grant/Funding Number)

FORP-PT-004

2011.1.197.58.3 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

4 mini dental implants

Experimental group

Description:

Retention of an overdenture by means of 4 mini implants.

Treatment:

Device: Implant-retained mandibular overdenture

2 mini dental implants

Experimental group

Description:

Retention of an overdenture by means of 2 mini implants.

Treatment:

Device: Implant-retained mandibular overdenture

2 conventional dental implants

Active Comparator group

Description:

Retention of an overdenture by means of 2 conventional implants associated to ball attachments.

Treatment:

Device: Implant-retained mandibular overdenture