Dept Oral and Maxillofacial Surgery UMCG
Groningen, Provincie Groningen, 9713GZ, Netherlands
NCT Number: NCT05650099
* 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.
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Notify Me18 year and older
All sexes
Observational
Groningen, Provincie Groningen, 9713GZ, Netherlands
The study design is an observational study of a group of 126 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.
All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having a missing tooth in the posterior region and were treated with a dental implant. Patients will have a regular routine control visit (as part of regular follow-up of these patients). All data to be collected are part of the routine visit and collected regularly at earlier routine visits, except for the questionnaire. The questionnaire contains a limited number of questions with respect to satisfaction with the function of the implant-supported restoration. If patients are willing to participate (to use their research data and to fill in the questionnaire), they will be asked to give informed consent by signing a form. After signing, they will be included in the 10-years evaluation as participant. The forms will be collected in the CRF and in the medical record it will be noted that patient has signed the informed consent. Data will be collected during the routine control visit; patients will not have an extra visit for data collection.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
before treatment:
Exclusion criteria
at time of treatment:
All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of missing posterior teeth and were treated with dental implant placement and implant-supported restorations. Patients will have a regular routine control visit (as part of regular follow-up of these patients)
Time frame: Comparison initial radiograph with radiograph after 10 years
Change in peri-implant marginal bone level along the implant side measured on radiographs in millimetres
Time frame: 10 years
Percentage of initially placed of dental implants present after 10 years
Time frame: 10 years
Survival of implant restorations after 10 years
Time frame: Status at 10 years
Health of peri-implant soft tissues after 10 years measured with an ordinal index
Time frame: Satisfaction at 10 years
Satisfaction of patients measured with an VAS scale in questionnaire
University Medical Center Groningen
Other
Acronym: Performance
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