Abutment-free implant for a personalized monolithic zirconia implant crown in the posterior area: A randomized controlled clinical trial (TRI)
- Conditions
- K00-K14Diseases of oral cavity, salivary glands and jaws
- Registration Number
- DRKS00028075
- Lead Sponsor
- Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
1. Age: > 20 years;
2. Missing posterior tooth (premolar or molar);
3. Presence of one adjacent tooth or implant to the implant site;
4. Presence of antagonist;
5. Adequate oral hygiene (Bleeding on probing <20%; plaque index <20%);
6. Capability to comply with the study procedures;
7. Signed Informed Consent Form
1. Pregnant or lactating women;
2. Known or suspected non-compliance, drug or alcohol abuse;
3. Smokers (>10 cigarettes/day);
4. Currently taking drugs that influence bone metabolism;
5. Use of bisphosphonates in the last 4 years;
6. History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years
7. General medical contraindication for oral surgery
8. Clinical signs and symptoms of bruxism, with or without self-report of bruxism
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is to show that the technical complication rate is smaller in the test than in the control group from baseline (2 to 4 weeks after delivery of the final crown) to 5-year values.
- Secondary Outcome Measures
Name Time Method The study aims to assess long-term performance regarding survival rate and radiographic and clinical parameters of an abutment-free all-ceramic implant crown compared to an all-ceramic crown supported by a regular titanium base abutment. Occurrence of AEs will be compared between both treatment groups.