Single tooth replacement with dental implants in the aesthetic zoneA randomized clinical trial of different implant designs and different times of restoration.
- Conditions
- Dental implant, single-tooth
- Registration Number
- NL-OMON25803
- Lead Sponsor
- - University Medical Center Groningen, University of Groningen- Nobel Biocare
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. The patient is 18 years or older;
2. The missing or lost tooth is an incisor (central or lateral), a canine or a first bicuspid in the maxilla. The adjacent teeth are natural teeth;
3. 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. In case of insufficient bone volume, a bone augmentation procedure will be performed with autologue bone. After three months of healing, the dental implant will then be inserted;
4. The implant site must be free from infection;
5. Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ¡Ü 1);
6. Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
7. If necessary, the temporary restoration can be designed free from occlusal contact;
8. The patient is capable of understanding and giving informed consent.
1. Medical and general contraindications for the surgical procedures;
2. Presence of an active and uncontrolled periodontal disease;
3. Presence of pathologic microflora;
4. Bruxism;
5. Site of implant placement is an extraction wound younger than three months;
6. Smoking (patients who stop smoking six weeks before the operation can be included);
7. A history of local radiotherapy to the head and neck region.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Esthetic Index according to Meijer et al. 2005.
- Secondary Outcome Measures
Name Time Method 1. Implant survival;<br>2. Marginal bone resorption;<br>3. Papil-index;<br>4. Recession;<br>5. Patient satisfaction.