Short Implants Supporting Single Crowns in the Posterior Region

NCT05081050 | Completed

• 1 other identifier: CAAE 26192919.5.0000.5336
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Prosthesis; Dental Implants; Quality of Life

Keywords

short implants; bone loss; prosthetic complications; implant survival; bone quality; patient centred outcome measures

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• OHIP-14 (Oral Health Impact Profile - 14)

  10-year follow-up

• Perimplant bone change from baseline to ten years

  from baseline to 10-year follow-up

Study Arms (1)

10-year Patients

Clinical and image examination to assess single crowns on short (6-mm) implants in the posterior region of the maxilla and mandible, according to functional, biological and technical variables, patient's satisfaction and quality of life.

Other: Only Follow-up

Interventions

Only Follow-up OTHER

No intervention is planned.

10-year Patients

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The 2010-cohort consisted of 20 patients who received 46 Standard Plus Wide Neck SLA (Straumann Dental Implant System, Waldenburg, Switzerland) 6-mm implants and metal-ceramic crowns cemented over SynOcta abutments (Straumann Dental Implant System, Waldenburg, Switzerland) in a private practice setting. The patients will be recalled for a 10-year follow-up research exam.

You may qualify if:

• need for single implants in the posterior region of the maxilla and mandible;
• indication of 6-mm implants according to preoperative evaluation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619900, Brazil

Location

Related Publications (5)

• 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.

  PMID: 28493384 BACKGROUND

• 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.

  PMID: 29145529 BACKGROUND

• 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.

  PMID: 30740630 BACKGROUND

• 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.

  PMID: 29621085 BACKGROUND

• 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.

  PMID: 24266703 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rosemary SA Shinkai, PhD

  Pontificia Universidade Católica do Rio Grande do Sul

  STUDY CHAIR

• Eduardo R Teixeira, PhD

  Pontificia Universidade Católica do Rio Grande do Sul

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 18, 2021
• Study Start: September 20, 2021
• Primary Completion: July 31, 2022
• Study Completion: March 1, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)