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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026732
Enrollment
40
Registered
2021-10-01
Start date
2021-09-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K08.2

Interventions

Group 1: Patients who have received soft tissue augmentation (with NovoMatrix) upon implantation due to a medical indication. Group 2: Patients who, due to a medical indication, did not receive any so

Sponsors

Universitätsklinik für Zahn, Mund- und Kieferheilkunde Klinik für Mund-, Kiefer- und Gesichtschirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Immunohistological reaction in the tissue preparation: distribution pattern of the Macrophages or foreign body giant cells, T cells, neutrophils, monocytes and fibroblasts.

Secondary

MeasureTime frame
Distribution pattern of the porcine Gala1-3Gal epitopes contained in the sample material.

Countries

Germany

Contacts

Public ContactTobias Fretwurst

Universitätsklinik für Zahn, Mund- und Kieferheilkunde Klinik für Mund-, Kiefer- und Gesichtschirurgie

tobias.fretwurst@uniklinik-freiburg.de+49 76127049820

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026