Quality of Life Clinical Trial
Official title:
Clinical Performance of 6-mm Short Implants Supporting Single Crowns in the Posterior Region: A 10-year Prospective Study
Verified date | December 2023 |
Source | Pontificia Universidade Católica do Rio Grande do Sul |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the present project is to evaluate functional, biological and technical variables, as well as quality of life and satisfaction as indicators of long-term clinical performance of single prostheses on short implants in the posterior region with a 10-year prospective follow-up. This proposal refers to a clinical research project with a 10-year follow-up of single crowns on short implants (6 mm) in the posterior region of the maxilla and mandible. The cohort has started in 2010 through a project funded by the International Team for Implantology. The main clinical results with a 4-year follow-up showed the influence of biomechanical factors (implant/crown ratio) on short-term treatment success and increased risk over time. The sample will consist of participants from the cohort of the research project established in 2010, who received a single crown on a short implant (6-mm Standard Plus Wide Neck SLA) in the posterior region of the maxilla or mandible according to eligibility criteria and standardized clinical procedures. Data will be collected by clinical and image exams, questionnaires (for sleep bruxism, satisfaction and quality of life), recording of maximum occlusal force, measurement of perimplant bone changes, and calculation of the clinical crown-implant ratio. Data will be analyzed by descriptive and inferential statistics with survival analysis and multivariable models, if assumptions are met, at the significance level of 0.05.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 1, 2023 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years and older |
Eligibility | The study sample will consist of participants from the 2010-cohort, who were selected according to the following eligibility criteria: Inclusion Criteria: - need for single implants in the posterior region of the maxilla and mandible; - indication of 6-mm implants according to preoperative evaluation Exclusion Criteria: - previous problems with osseointegration failure in the region of interest; - bone graft or use of biomaterials; - diabetes; - heavy tobacco use (over 10 cigarettes per day); - immunosuppression; - local radiation therapy; - poor oral hygiene; - active periodontal disease in the remaining teeth; - cystic or neoplastic lesions; - removable dentures in the opposing arch. |
Country | Name | City | State |
---|---|---|---|
Brazil | Pontificia Universidade Catolica do Rio Grande do Sul | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidade Católica do Rio Grande do Sul | ITI International Team for Implantology, Switzerland |
Brazil,
Alonso FR, Triches DF, Mezzomo LAM, Teixeira ER, Shinkai RSA. Primary and Secondary Stability of Single Short Implants. J Craniofac Surg. 2018 Sep;29(6):e548-e551. doi: 10.1097/SCS.0000000000004567. — View Citation
Mezzomo LA, Miller R, Triches D, Alonso F, Shinkai RS. Meta-analysis of single crowns supported by short (<10 mm) implants in the posterior region. J Clin Periodontol. 2014 Feb;41(2):191-213. doi: 10.1111/jcpe.12180. Epub 2013 Nov 25. — View Citation
Triches DF, Alonso FR, Mezzomo LA, Schneider DR, Villarinho EA, Rockenbach MI, Teixeira ER, Shinkai RS. Relation between insertion torque and tactile, visual, and rescaled gray value measures of bone quality: a cross-sectional clinical study with short implants. Int J Implant Dent. 2019 Feb 11;5(1):9. doi: 10.1186/s40729-019-0158-6. — View Citation
Villarinho EA, Correia A, Vigo A, Ramos NV, Pires Vaz MA, Arai Shinkai RS. Volumetric Bone Measurement Around Dental Implants Using 3D Image Superimposition: A Methodological and Clinical Pilot Study. Int J Prosthodont. 2018 January/February;31(1):23-30. doi: 10.11607/ijp.5366. Epub 2017 Nov 16. — View Citation
Villarinho EA, Triches DF, Alonso FR, Mezzomo LAM, Teixeira ER, Shinkai RSA. Risk factors for single crowns supported by short (6-mm) implants in the posterior region: A prospective clinical and radiographic study. Clin Implant Dent Relat Res. 2017 Aug;19(4):671-680. doi: 10.1111/cid.12494. Epub 2017 May 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ten-year Implant survival | Survival of short implant (6-mm) placed in the posterior region as assessed through clinical-radiographic examination at the 10-year follow-up, according to success clinical criteria, i.e., no problem that lead to implant loss or removal. | 10-year follow-up | |
Primary | Ten-year prosthesis survival | Survival of single crown supported by short implant placed in the posterior region as measured through clinical-radiographic examination at the 10-year follow-up, according to success clinical criteria, i.e., no problem that lead to prosthesis loss or removal. | 10-year follow-up | |
Secondary | OHIP-14 (Oral Health Impact Profile - 14) | Self-reported general satisfaction and oral health-related quality of life as measured by the instrument OHIP-14 (Oral Health Impact Profile - 14) | 10-year follow-up | |
Secondary | Perimplant bone change from baseline to ten years | Perimplant bone change will be assessed by using radiographic images to measure the vertical bone loss from the implant platform to the most coronal level of the bone-implant contact, on both mesial and distal implant surfaces, and averaged. | from baseline to 10-year follow-up |
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