Mandibular Overdentures Retained by Conventional or Mini Implants
NCT ID: NCT01411683
Last Updated: 2017-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2011-09-30
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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4 mini dental implants
Retention of an overdenture by means of 4 mini implants.
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.
2 mini dental implants
Retention of an overdenture by means of 2 mini implants.
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.
2 conventional dental implants
Retention of an overdenture by means of 2 conventional implants associated to ball attachments.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
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Raphael Freitas de Souza
Associate Professor
Principal Investigators
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Raphael F de Souza, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Ribeirão Preto Dental School
Ribeirão Preto, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Institutional page of the Ribeirão Preto Dental School (research site)
Principal Investigator´s CV (RF de Souza)
Principal Investigator´s CV (RF Albuquerque Jr)
Other Identifiers
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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
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