Mandibular Overdentures Retained by Conventional or Mini Implants

Edentulous Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411683
• Other study ID #: FORP-PT-004
• Secondary ID: 2011.1.197.58.32
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: April 13, 2017
• Start date: September 2011
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

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.

Related Conditions & MeSH terms

• Edentulous Jaw
• Edentulous Mouth
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Device:
• Implant-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.

Locations

Country	Name	City	State
Brazil	Ribeirão Preto Dental School	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Chaves CA, Souza RF, Cunha TR, Vecchia MP, Ribeiro AB, Bruniera JF, Silva-Sousa YT. Preliminary In Vitro Study on O-Ring Wear in Mini-Implant-Retained Overdentures. Int J Prosthodont. 2016 Jul-Aug;29(4):357-9. doi: 10.11607/ijp.4677. — View Citation

de Souza RF, Ribeiro AB, Della Vecchia MP, Costa L, Cunha TR, Reis AC, Albuquerque RF Jr. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial. J Dent Res. 2015 Oct;94(10):1376-84. doi: 10.1177/0022034515601959. Epub 2015 Aug 20. — View Citation

dos Reis AC, León JE, Ribeiro AB, Della Vecchia MP, Cunha TR, de Souza RF. Traumatic ulcerative granuloma with stromal eosinophilia around mini dental implants without the protection of a denture base. J Prosthodont. 2015 Jan;24(1):83-6. doi: 10.1111/jopr — View Citation

Ribeiro AB, Della Vecchia MP, Cunha TR, Sorgini DB, Dos Reis AC, Muglia VA, de Albuquerque RF Jr, de Souza RF. Short-term post-operative pain and discomfort following insertion of mini-implants for retaining mandibular overdentures: a randomized controlle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Denture satisfaction	To be assessed by specific questionnaires	2 years
Primary	Oral health-related quality of life	To be assessed by means of the Brazilian version of the OHIP-EDENT.	2 years
Secondary	Post-surgical discomfort	Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.	7 days
Secondary	Success rate of implant-retained mandibular overdentures	Survival of implant-retained overdentures.	2 years
Secondary	Denture quality	Functional aspects of mandibular overdentures, as assessed by a dentist.	2 years
Secondary	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

External Links

•   Institutional page of the Ribeirão Preto Dental School (research site)
•   Principal Investigator´s CV (RF Albuquerque Jr)
•   Principal Investigator´s CV (RF de Souza)