Prospective, controlled immunhistological analysis of soft tissue graft with acelullar porcine dermal matrix above dental implants

Not Applicable

Recruiting

• Conditions: K08.2; Atrophy of edentulous alveolar ridge

• Registration Number: DRKS00026732
• Lead Sponsor: niversitätsklinik für Zahn, Mund- und Kieferheilkunde Klinik für Mund-, Kiefer- und Gesichtschirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

1) Patients who receive an implant treatment due to a medical indication with soft tissue augmentation (with NovoMatrix) or without soft tissue augmentation at the same time as implantation.
2) People over the age of 18 in the sense of the age of majority, as well as full legal capacity (§§ 2 BGB).
3) Non-smokers and moderate smokers = 20 cigarettes / day
4) Good oral hygiene and plaque control of the patient (full mouth plaque score = 25%)
5) The patient that was informed about the follow-up examinations and agrees to participate in them.

Exclusion Criteria

1) Dependent persons or persons in custody
2) General diseases that contradict dental implant therapy (e.g. diabetes mellitus not ceased)
3) Previous history of non-compliance and / or unreliability)
4) Diseases of the mucous membrane (e.g. erosive lichen planus)
5) Untreated endodontic or periodontal lesions with probing of the PD of = 4mm directly adjacent to the planned implant position
6) Patients with inadequate oral hygiene (full mouth plaque score> 25%) or gingivitis
6) Heavy nicotine abuse (> 20 cigarettes / day) or consumption of chewing tobacco
7) Pregnant or breastfeeding women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunohistological reaction in the tissue preparation: distribution pattern of the<br>Macrophages or foreign body giant cells, T cells,<br>neutrophils, monocytes and fibroblasts.

Secondary Outcome Measures

Name	Time	Method
Distribution pattern of the porcine Gala1-3Gal epitopes contained in the sample material.