Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06634043

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Gingival Recession Gingival Diseases Gingival Recession, Localized Mouth Diseases Mucogingival Defects Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients with ≥18 years of age. ability to understand all the study procedures and to comply with them throughout the entire study period. Ability and willingness to give written informed consent.

an adequate level of oral hygiene (plaque index ≤ 25%) (O'Leary et al., 1972).

an adequate general bleeding on probing (≤ 20%) treated periodontal disease. presence of two or more adjacent Cairo type I or II gingival recessions, with ≥1mm of keratinized gingiva in all the deffects.

Exclusion criteria

  • untreated periodontitis.
  • smokers > 5 cigarettes per day.
  • local or systemic diseases that would interfere with routine periodontal therapy (i.e., uncontrolled diabetes mellitus, cancer, HIV, chronic high-dose steroid therapy, metabolic bone disease, radiation, immunosuppressive disease, hepatic dysfunction, immunosuppressive disease, autoimmune disease).
  • treatment with anticoagulants or bisphosphonates.
  • pregnant or lactating women.
  • radiographic interproximal bone loss.
  • tooth Mobility. If present, splinting should be performed prior to treatment.
  • Active orthodontic treatment
  • allergy or intolerance to study medication
  • use of systemic antibiotics during the last 3 months
  • use of systemic antibiotics for endocarditis prophylaxis
  • patients with intentions to change residence that prevent follow-up

Treatment and study plan

Coronally Advanced Tunel + ADM (Novomatrix®)

Procedure

ADM (Novomatrix®) will be used alone

Other names: Control

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

Procedure

ADM in combination with L-Prf will be applied

Primary outcomes

  1. Root Coverage

    Time frame: 6 months

    Percentage of root coverage after 6 month

Secondary outcomes

  1. Patients satisfaction

    Time frame: 6 months

    health-related quality-of-life tool,specified on root coverage procedures, with a 0 to 10 pointscale used for assessing the level of concern of the following patient-centered criteria: a) general esthetics, b)cost/benefit c)general experience.

    10 being the best and 0 being the poorest score.

  2. Patients Morbidity

    Time frame: 6 months

    Post Operative pain measured with visual analogue scale where the level of pain will be assessed according to the grades from 0 to 10.

  3. presence of dentin hipersensitivity

    Time frame: 6 months

    Measured with a visual analogue scale after external stimuli applied to the surface of exposed dentin with open tubules, the level of pain will be assessed according to the grades of pain from 0 to 10.

  4. Pink Esthetic Scores results

    Time frame: 6 months

    The pink esthetic score (PES) provides a reproducible method for evaluating papilla form as well as other soft tissue variables including color and surface.

    The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture.

    Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.

  5. presence of dentin hipersensitivity

    Time frame: 6 months

    Measured with a visual analogue scale after external stimuli applied to the surface of exposed dentin with open tubules, he level of pain will be assessed according to the grades of pain from 0 to 10.

Study contacts

Contact information is provided by the study sponsor or research team.

Andres M Pascual, DDS, PhD

CONTACT

[email protected]

+34627725044

Juan M Aragoneses, MD, DDS, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Andres Matteo Pascual La Rocca

Other

Registry information

Official study title

Coronally Advanced Tunnel Combined With Xenogenic Dermal Matrix and L-PRF for the Treatment of Cairo&Amp;#39;s Type 1 and Type 2 Multiple Recessions: A Randomized Comparative Study

Acronym: CAF+XADM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.