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ID
Source
Brief title
Health condition
The missing tooth is a molar in maxilla or mandible
Sponsors and support
Intervention
Outcome measures
Primary outcome
• evaluation of technical complications of screw-retained full-anatomic zirconia crowns without abutment in the posterior maxilla and mandible during a 1-year follow-up.
Secondary outcome
• Implant survival
• Peri-implant bone level change
• Probing pocket depth
• Amount of plaque
• Mucosa condition
• Patient satisfaction
Background summary
• Background
Implant-supported single crowns are still prone to some complications. Technical complications are breakage of the porcelain and mobility of the crown due to loosening of the screw. Of monolithic zirconia restorations is almost no fracture reported because no porcelain is used. To reduce loosening of the screw-retention, a number of possibilities has been developed. A better fit of the connection between implant and crown and the absence of an extra abutment between implant and crown have resulted in less loosening. Studies evaluating these three developments in one study design are limited.
• Main research question
The primary objective of the study is evaluation of technical complications of screw-retained full-anatomic zirconia crowns without abutment in the posterior maxilla and mandible during a 1-year follow-up.
• Design (including population, confounders/outcomes)
The study design is a prospective observational study of a group of patients which will be treated with a dental implant and a full-zirconia implant-supported crown without abutment because of a missing tooth in the posterior region. Outcomes: primary outcome is the frequency of technical complications; secondary outcome measures will be implant survival, peri-implant bone level change, peri-implant mucosa health and patients’ satisfaction using a questionnaire.
Study objective
Absence of technical complications, high implant survival, stable peri-implant bone levels, and satisfied patients.
Study design
Evaluation at 1-year follow-up
Intervention
Dental implant placement and restoration without interconnecting abutment
Inclusion criteria
Inclusion criteria:
• Patients referred to the department of Oral and Maxillofacial Surgery (UMCG) because of having a missing tooth in the posterior region.
• The patient is 18 years or older;
• The missing tooth is a molar in maxilla or mandible;
• Sufficient healthy and vital bone to insert a dental implant with a minimum length of 8 mm and at least 4.0 mm in diameter with initial stability > 45 Ncm
• The implant site is 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 is capable of understanding and giving informed consent.
Exclusion criteria
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
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 | NL9418 |
| Other | METc UMCG : METc 2021/253 Ref M21.274463 |