K08.1
Conditions
Interventions
Group 1: The patients of a group in arm 1 obtain during the surgery a Collagen Matrix 10808, in order to gain a mucosal thickness around an implant placement.
Group 2: The patients of a group in arm 2
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. 18 years or older 2. Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures 3. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form 4. Necessity of soft tissue augmentation in a single tooth gap 5. Implant placement at least 6 weeks prior baseline examination 6. One tooth adjacent to each side of the defect with a mean BOP of < 20% 7. Basic periodontal examination (BPE) <2
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.Presence of a bony dehiscence >3 mm at the implant site assessed at the time of surgery (soft tissue augmentation) 2.Heavy smoker (> 10 cigarettes per day) 3.Presence of periodontal disease 4.Insulin dependent diabetes 5.General contraindications for dental and/or surgical treatment 6.History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years 7.Women of child bearing age, not using a highly effective method of birth control 8.Pregnancy or breast feeding 9.Previous and concurrent medication affecting mucosal healing in general (e.g. topical steroids, large doses of anti-inflammatory drugs) 10.Disease affecting connective tissue metabolism 11.Any systemic diseases that contraindicate implant placement 12.Allergy to collagen 13.Participation in an investigational device or drug clinical trial within the last six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gain in mucosal soft tissue thickness at day 120 compared to Baseline value measured by trans-mucosal probing at the crest (occlusal) of the soft tissue ridge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints to be assessed are: 1.Assessment of AEs from Visit 1 to Visit VIII 2.Closure of the wound at day 0 (BL 1), 10, 30, 120 3.Presence of swelling at day 0 (BL 1), 10, 30, 120 4.Oral health impact profile (OHIP-G14) score at day 0 (BL 1), 10 and 120 5.Daily cumulative Ibuprofen consumption between day 0 (BL 1) and day 10 6.Cumulative Ibuprofen consumption between day 10 and day 30 and day 30 and 120 7.Evaluation of pain using a VAS score daily between day 0 (BL 1) and day 10 and at day 30 and at day 120 8.Surgery time Effectiveness endpoints: 1.Gain in mucosal soft tissue thickness at day 120 compared to day 0 (BL 1) value measured by trans-mucosal probing (buccal, apical) of the soft tissue ridge. 2.Gain in mucosal soft tissue thickness measured at day 30 compared to day 0 (BL 1) by trans-mucosal probing (occlusal, buccal, apical) 3.Gain in mucosal soft tissue thickness at day 30 and 120, compared to day 0 (BL 1) based on a 3D volumetric analysis 4.Changes in mucosal soft tissue volume between final restoration at day 180 (Final Restoration / BL 2), compared to day 360 after BL 2 based on a 3D volumetric analysis 5.Changes in mucosal soft tissue thickness measured at day 360 after final restoration (BL 2) compared to day 180 (Final restoration / BL 2) by trans-mucosal probing 6.KT width, PD, CAL, BOP, PI at day 0 (BL 1) and at day 120 7. Soft tissue esthetics measured at day 180 (Final restoration / BL 2) and 360 after Final restoration (BL 2) | — |
Countries
France, Germany, Italy, Spain, Switzerland
Contacts
Public ContactMarco Nief
Geistlich Pharma AG
Outcome results
None listed