on-interventional long-term follow-up observation of soft tissue around final restorations following previous soft tissue augmentation in single tooth gaps
- Conditions
- K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00017484
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
The 20 patients who participated in the study 10860-001:
1. Successful soft tissue augmentation in study 10860-001;
2. Final restoration at implant site;
3. Ability to fully understand the nature of the proposed long-term follow-up study and ability to sign the informed consent form.
Exclusion Criteria
1. Newly developed diseases interfering with soft tissue regeneration (e.g. diabetes);
2. Peri-implant infection (not related to previously performed soft tissue regeneration) following the insertion of the final reconstruction;
3. Second soft tissue augmentation since completion of study 10860-001;
4. Severe trauma to implant site;
5. Orthodontic treatment in the same quadrant.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness endpoints:<br>1. Assessment of long-term stability of mucosal soft tissue thickness around implants measured at day 0 (baseline) and 0.5, 1, 3 and 5 years by trans-mucosal probing;<br>2. Assessment of long-term stability of mucosal soft tissue thickness around implants based on a 3D volumetric analysis;<br>3. keratinized tissue width, probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), periodontal index (PI) at day 0 (baseline) and after 0.5, 1, 3 and 5 years;<br>4. Aesthetic parameters (pink esthetic score (PES), papilla evaluation, soft tissue recession evaluation, spectroshade measurements) at day 0 (Baseline), 0.5, 1, 3 and 5 years.<br>
- Secondary Outcome Measures
Name Time Method Safety endpoints to be assessed are: <br>1. Assessment of AEs;<br>2. Oral health impact profile (OHIP-G14) score at day 0 (Baseline), and 0.5, 1, 3 and 5 years.