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ID
Source
Brief title
Health condition
The study design is an observational study of a group of 120 patients who were treated 5 years ago with immediate dental implant placement and an implant-supported restoration because of having a failing tooth in the maxillary aesthetic region or, in case of a post-extraction defect, were treated with an alveolar ridge preservation, delayed implant placement and an implant-supported restoration.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in peri-implant marginal bone level.
Secondary outcome
• Implant survival and restoration survival
• Change in mid-buccal mucosal level
• Changes in inter-proximal mucosal
• Peri-implant mucosa and implant crown aesthetics assessed from photographs using the Pink Esthetic Score-White Esthetic Score (PES/WES).
• Probing pocket depth
• Amount of plaque
• Mucosa condition
• Volume of the interproximal papilla, using the papilla index
• Patient satisfaction
Background summary
• Background
There is a growing tendency to place single tooth dental implants in the aesthetic zone immediately after extracting a failing tooth, preferably combined with immediate provisionalization. If a post-extraction site has a bone defect, so not full-filling the requirements for immediate implant placement, an alveolar ridge preservation is mandatory. Full-scale evaluation of immediate implant placement and implant placement after alveolar ridge preservation with a follow-up of at least 5 years is underreported in this field of implant dentistry.
• Main research question
The aim of this 5-years observational study was to analyze peri-implant bone changes, mucosa levels, effect of type of soft tissue augmentation technique, aesthetic ratings and patient-reported satisfaction with the maxillary aesthetic region following immediate implant placement and implant placement after alveolar ridge preservation.
• Design (including population, confounders/outcomes)
The study design is an observational study of a group of patients which were treated 5 years ago with immediate dental implant placement and an implant-supported restoration because of having a failing tooth in the maxillary aesthetic region. In case of a post-extraction defect, patients were treated with an alveolar ridge preservation, delayed implant placement and an implant-supported restoration. Outcomes: primary outcome is the change in marginal peri-implant bone level 5 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival and changes in interproximal peri-implant mucosa, midfacial peri-implant mucosal level , effect of soft tissue augmentation technique, aesthetic outcome assessed by means of an objective index and patients’ satisfaction using a questionnaire.
Study objective
Stable peri-implant bone levels, stable peri-implant soft tissue levels, high implant and restoration survival rate and satisfied patients.
Study design
Evaluation 5 years after treatment.
Intervention
Follow-up evaluation after 5 years.
Inclusion criteria
• Patients referred to the department of Oral and Maxillofacial Surgery 5 years ago and treated with immediate dental implant placement and an implant-supported restoration because of having a failing tooth in the maxillary aesthetic region or, in case of a post-extraction defect, were treated with an alveolar ridge preservation, delayed implant placement and an implant-supported restoration. At the time of treatment:
• The patient was 18 years or older;
• The failing tooth was an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
• Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 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 temporary restoration could be designed free from occlusal contact;
• The patient was capable of understanding and giving informed consent.
Exclusion criteria
• 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.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9860 |
| Other | METc UMCG : METc 2021/616; M21.285739; UMCG RR number 202100767 |