Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05650099
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2022-12-06
Brief Title:
Peri-implant Health of Dental Implants in the Posterior Region an Evaluation After 10 Years
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Peri-implant Health of Dental Implants in the Posterior Region an Evaluation After 10 Years
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Performance
Brief 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
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
Detailed Description:
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
Inclusion criteria
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 85 mm and at least 40 mm in diameter with initial stability 45 Ncm
The 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 the time of treatment
Medical and general contraindications for the surgical procedures
Presence of an active and uncontrolled periodontal disease
Bruxism
Smoking
A history of local radiotherapy to the head and neck 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
Inclusion criteria
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 85 mm and at least 40 mm in diameter with initial stability 45 Ncm
The 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 the time of treatment
Medical and general contraindications for the surgical procedures
Presence of an active and uncontrolled periodontal disease
Bruxism
Smoking
A history of local radiotherapy to the head and neck 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None