Clinical trial NCT01411683: Mandibular Overdentures Retained by Conventional or Mini Implants
Official title: Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Mouth
Edentulous Jaw
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
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Denture satisfaction
timeFrame: 2 years
measure: Oral health-related quality of life
timeFrame: 2 years
Secondary outcomes:
measure: Post-surgical discomfort
timeFrame: 7 days
measure: Success rate of implant-retained mandibular overdentures
timeFrame: 2 years
measure: Denture quality
timeFrame: 2 years
measure: Treatment costs
timeFrame: 2 years
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Ribeirão Preto Dental School
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Raphael F de Souza, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 controlled trial. J Oral Rehabil. 2015 Aug;42(8):605-14. doi: 10.1111/joor.12287. Epub 2015 Mar 13.
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.
citation: 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.
citation: 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.