Mandibular Overdentures Retained by Conventional or Mini Implants

NCT ID: NCT01411683

Last Updated: 2017-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Edentulous Mouth Edentulous Jaw

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

4 mini dental implants

Retention of an overdenture by means of 4 mini implants.

Group Type EXPERIMENTAL

Implant-retained mandibular overdenture

Intervention Type DEVICE

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.

2 mini dental implants

Retention of an overdenture by means of 2 mini implants.

Group Type EXPERIMENTAL

Implant-retained mandibular overdenture

Intervention Type DEVICE

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.

2 conventional dental implants

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

Group Type ACTIVE_COMPARATOR

Implant-retained mandibular overdenture

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

- Mini-implant overdenture.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Raphael Freitas de Souza

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raphael F de Souza, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27479342 (View on PubMed)

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 controlled trial. J Oral Rehabil. 2015 Aug;42(8):605-14. doi: 10.1111/joor.12287. Epub 2015 Mar 13.

Reference Type RESULT
PMID: 25765784 (View on PubMed)

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.

Reference Type RESULT
PMID: 26294416 (View on PubMed)

dos Reis AC, Leon 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.12184. Epub 2014 Jun 27.

Reference Type RESULT
PMID: 24975725 (View on PubMed)

Della Vecchia MP, Leles CR, Cunha TR, Ribeiro AB, Sorgini DB, Muglia VA, Reis AC, Albuquerque RF Jr, de Souza RF. Mini-Implants for Mandibular Overdentures: Cost-Effectiveness Analysis alongside a Randomized Trial. JDR Clin Trans Res. 2018 Jan;3(1):47-56. doi: 10.1177/2380084417741446. Epub 2017 Nov 20.

Reference Type DERIVED
PMID: 30938654 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.forp.usp.br

Institutional page of the Ribeirão Preto Dental School (research site)

http://lattes.cnpq.br/7092555880664311

Principal Investigator´s CV (RF de Souza)

http://lattes.cnpq.br/5953029548378417

Principal Investigator´s CV (RF Albuquerque Jr)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011.1.197.58.3

Identifier Type: OTHER

Identifier Source: secondary_id

2011/00688-7

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FORP-PT-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.