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Coronally Advanced Tunnel Combined With Xenogenic Dermal Matrix and L-PRF

NCT06634043 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-01-28

No results posted yet for this study

Summary

Gingival recession is the exposure of the root surface due to the gum margin moving away from the crown of the tooth. It's common in adults and becomes more prevalent and severe with age. About 50% of people aged 18-64 and up to 88% of those over 65 have at least one site with gingival recession. The causes are multifactorial, including factors like aggressive brushing, thin gum tissue, orthodontic treatments, and more.

A systematic review found that untreated gingival recessions tend to worsen over time, with a significant increase in both the number of sites and the depth of the recession. A new classification system for gingival recessions has been proposed, categorizing them based on the detection of the cementoenamel junction (CEJ) and interproximal attachment loss.

Surgical techniques aim to restore the gum margin to its original position with minimal probing depths and good aesthetic results. The standard treatment involves a connective tissue graft from a donor site, but newer methods using substitutes like collagen matrices and platelet concentrates have shown comparable results.

Acellular Dermal Matrix (ADM) is a processed dermal tissue used as a substitute for connective tissue in root coverage and implant soft tissue corrections. It has shown favorable results, especially in reducing patient morbidity and thickening the gingival phenotype. ADM can be combined with a coronally positioned flap or tunnel technique for effective root coverage.

The use of platelet concentrates, such as Leukocyte and Platelet-Rich Fibrin (L-PRF), has also become an important alternative. These concentrates improve healing by providing growth factors and cytokines, aiding in the development of microvascularization.

The objective is to assess whether combining Acellular Dermal Matrix (ADM) with Leukocyte and Platelet-Rich Fibrin (L-PRF) yields better or comparable results to ADM alone in terms of complete root coverage, percentage of root coverage (PRC), recession reduction (RecRED), gain of keratinized gingiva (KGG), height of the interdental papilla (IDH), and increased gingival thickness (GT) after 6 months.

Conditions

  • Gingival Recession
  • Gingival Recession, Localized
  • Mucogingival Defects

Interventions

PROCEDURE

Coronally Advanced Tunel + ADM (Novomatrix®)

ADM (Novomatrix®) will be used alone

PROCEDURE

Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF

ADM in combination with L-Prf will be applied

Sponsors & Collaborators

  • Andres Matteo Pascual La Rocca

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-05-30
Completion
2026-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634043 on ClinicalTrials.gov