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| ID | Type | Description | Link |
|---|---|---|---|
| 2011.1.197.58.3 | Other Identifier | Institutional Review Board (FORP-USP) | |
| 2011/00688-7 | Other Grant/Funding Number | FAPESP |
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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mini dental implants | Experimental | Retention of an overdenture by means of 4 mini implants. |
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| 2 mini dental implants | Experimental | Retention of an overdenture by means of 2 mini implants. |
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| 2 conventional dental implants | Active Comparator | Retention of an overdenture by means of 2 conventional implants associated to ball attachments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant-retained mandibular overdenture | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Denture satisfaction | To be assessed by specific questionnaires | 2 years |
| Oral health-related quality of life | To be assessed by means of the Brazilian version of the OHIP-EDENT. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical discomfort | Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire. | 7 days |
| Success rate of implant-retained mandibular overdentures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphael F de Souza, DDS, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ribeirão Preto Dental School | Ribeirão Preto | São Paulo | 14040-904 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27479342 | Result | 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. | |
| 25765784 | Result | 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. |
| Label | URL |
|---|---|
| Institutional page of the Ribeirão Preto Dental School (research site) | View source |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| D007575 | Jaw, Edentulous |
| D010342 | Patient Acceptance of Health Care |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D007571 | Jaw Diseases |
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Survival of implant-retained overdentures.
| 2 years |
| Denture quality | Functional aspects of mandibular overdentures, as assessed by a dentist. | 2 years |
| Treatment costs | This outcome will be measured by means of specific forms, according to 2 components:
| 2 years |
| 26294416 | Result | 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. |
| 24975725 | Result | 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. |
| 30938654 | Derived | 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. |
| Principal Investigator“s CV (RF de Souza) | View source |
| Principal Investigator“s CV (RF Albuquerque Jr) | View source |
| D009140 |
| Musculoskeletal Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |