Prospective clinical study to evaluate the clinical performance of immediately placed PL implants: A monocenter study
- Conditions
- K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00016500
- Lead Sponsor
- Johann Wolfgang Goethe Universität FrankfurtZentrum der Zahn-, Mund- und KieferheilkundeCarolinum Zahnärztliches Universitäts-Institut gGmbHPoliklinik für Zahnärztliche Chirurgie und Implantologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 25
1. Males and females with an age of 18 to 69 years
2. Planned single tooth replacement in maxilla (14-24 FDI) allowing the placement of a single implant
3. Adjacent teeth have to be free of acute or chronical infections (e.g. periodontal or endodontic problems)
4. Single tooth gaps (i.e. natural tooth roots present on the sides adjacent to the implant)
5. Opposing dentition must be natural teeth or fixed restoration
6. Subject shall have a stable occlusal relationship
7. Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visits
8. Subjects must have voluntarily signed the informed consent form before any study related action
1. Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
2. Any contraindications for oral surgical procedures (according to instruction for use of implant system)
3. Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew tobacco
4. Bone metabolism disorders
5. Uncontrolled para-functional diseases (bruxism, clenching or grinding of teeth)
6. Disorders that impede the ability of patients to maintain adequate oral hygiene
7. Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
8. Any implant that cannot be immediately provisionalized or receive an individual healing abutment and need to be submerged healed will be excluded from the study
9. Pregnant or breastfeeding women
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Implant success as evidenced by clinical and immunological outcome measures:<br>Clinical:<br>- Bleeding on probing (BOP)<br>- Mucosal recession (MR)<br>- Probing pocket depths (PD)<br>- Clinical attachment level (CAL)<br>Measured at final restoration, at 6-month, 1-, 2-, 3-, 4-, 5-year post implant placement.<br>Immunological (paper strip):<br>- aMMP-8 (Matrix-Metalloproteinase-8) <br>Measured at final restoration, at 6-month and 1-year post implant placement.
- Secondary Outcome Measures
Name Time Method At implant surgery: <br>- ISQ (resonance frequency analysis, Osstell)<br>- Insertion torque<br>- Soft tissue thickness<br>- Alveolar structure assessment<br>At final restoration, at 1-, 3-, and 5-year follow-up:<br>- Patient satisfaction (PROMs)<br>Clinical parameters at final restoration and at each follow-up for up to 5 years post-surgery:<br>Soft tissue parameters<br>- Pink esthetic score (PES, acc. Fürhauser)<br>- Plaque index (PI)<br>Oral hygiene measures<br>As required:<br>- Evaluation of any complications and adverse events (i.e. safety analysis).<br>