Clinical Performance of 6-mm Short Implants Supporting Single Crowns in the Posterior Region: A 10-year Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Ten-year Implant survival
Study Overview
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.
Detailed Description
AIMS
General Aim:
To evaluate the clinical performance of single crowns on short (6-mm) implants in the posterior region of the maxilla and mandible, according to functional, biological and technical variables, as well as patient satisfaction and quality of life as indicators of clinical success after ten years of use.
Specific Aims: This study will
- Measure the long-term success and survival rates of short implants (6-mm) and single crowns in the posterior region, through a 10-year prospective follow-up.
- Identify risk factors for failure and complication of short implant and single crowns.
- Compare the general satisfaction and quality of life of patients with and without failures/complications.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Ten-year Implant survival
Time Frame: 10-year follow-up
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.
Ten-year prosthesis survival
Time Frame: 10-year follow-up
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.
Secondary Outcomes
- 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)