Treatment of single and multiple soft tissue recessions of Miller classes I, II and III with a new reconstructive tissue matrix using the coronally displaced tunnel technique. A prospective clinical two-center cohort study.

Phase 4

Recruiting

• Conditions: Gingivitis and periodontal diseases; GINGIVAREZESSIONEN; K05

• Registration Number: DRKS00023201
• Lead Sponsor: Oral Reconstruction Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male and female persons over the age of 18 in the sense of the age of majority, as well as full legal capacity (§§ 2 BGB).
2. Periodontal and general medical healthy patients.
3. Single or multiple ginigvar recessions of the upper and / or lower jaw (Miller classes I to III).
4. The patient was informed about the follow-up examinations relevant to the study and agrees to participate in them.
5. Good oral hygiene and patient plaque control (FMPS <20%).

Exclusion Criteria

1. Miller class IV gingival recession.
2. General diseases that contradict dental implant therapy (e.g. diabetes mellitus that has not been discontinued).
3. Any contraindications to oral surgery.
4. Tobacco consumption (in the form of cigarettes, chewing tobacco, etc.).
Systemic diseases (diseases of the cardiovascular system, bleeding disorders (including the use of anticoagulants), metabolic bone diseases, chemotherapy or radiation, chronic inflammation, metabolic or systemic dysfunction associated with lesions and / or altered bone healing).
6. Taking drugs that block or alter bone healing.
7. Uncontrolled parafunctions (bruxism (clenching of the teeth, grinding)).
8. Intraoral infections.
9.Dysfunctions / diseases / conditions that impede the patient's ability to maintain adequate oral hygiene.
10. Conditions and circumstances which, according to the evaluation of the study director or his deputy, would hinder the completion of the study participation and the analysis of the results (e.g. previous history of non-compliance and / or unreliability).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation root coverage after 12 months (mean Root Coverage-mRC in %)

Secondary Outcome Measures

Name	Time	Method
Digital evaluation of the soft tissue volume (by means of an extra-oral scan of plaster models) before, as well as six and twelve months post-augmentation