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NCT05650099
Peri-implant Health of Dental Implants in the Posterior Region; an Evaluation After 10 Years
Conditions: Missing Teeth
Sex: All
Ages: 18 Years – N/A
Enrollment: 126
Sponsor: University Medical Center Groningen
Location: Netherlands
Summary
Background Adaptation of a dental implant and its restoration to the existing anatomy in the region of a missing tooth is presumed to be a reliable procedure.
During the follow-up it appears that peri-implant bone level is stable, peri-implant soft tissues are healthy and patients are satisfied with the result.
However, the number of 10-years studies on implants in the posterior region of maxilla and mandible is limited and much more studies with longer follow-up periods are needed to confirm the positive outcomes.Main research question The primary objective of the study is marginal bone level changes by radiological assessments at 10-years follow-up.
Secondary objectives are implant and restoration survival, condition of peri- implant mucosa and patients' satisfaction.Design The study design is an observational study of a group of patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region.
Outcomes: primary outcome is the change in marginal peri-implant bone level 10 years after placing the definitive restoration.
Secondary outcome measures will be implant and restoration survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.Expected results Stable peri-implant bone levels, stable peri-implant soft tissue levels, high implant and restoration survival rate and satisfied patients.
Eligibility Criteria
Inclusion Criteria before treatment:Patients referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with a dental implant and an implant-supported restoration because of having a missing tooth in the posterior region.
At the time of treatment:The patient was 18 years or older;The missing tooth was a premolar or molar in maxilla or mandible;Sufficient healthy and vital bone to insert a dental implant with a minimum length of 8.5 mm and at least 4.0 mm in diameter with initial stability > 45 NcmThe implant site was free from infection;Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;The patient was capable of understanding and giving informed consent.Exclusion Criteria at time of treatment:Medical and general contraindications for the surgical procedures;Presence of an active and uncontrolled periodontal disease;Bruxism;SmokingA history of local radiotherapy to the head and neck region.
Source: ClinicalTrials.gov (NCT05650099). StuddyBuddy aggregates publicly available trial information.