Randomized controlled clinical multi-center study to investigate effectiveness and safety of a Collagen Matrix 10808 for soft tissue volume augmentation after implant placement in single tooth gaps compared to autogenous connective tissue graft

Not Applicable

• Conditions: K08.1; Loss of teeth due to accident, extraction or local periodontal disease

• Registration Number: DRKS00005944
• Lead Sponsor: Geistlich Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-03
• Study Completion: 2019-07-18
• Results First Posted: 2023-07-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 88

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
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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.