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

NCT06634043 | Not Yet Recruiting Phase 4

• 2 other identifiers: 2024 _ 4/269ORF42414
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

acellular dermal matrix; coronally advenced tunnel

Outcome Measures

Primary Outcomes (1)

• Root Coverage

  Percentage of root coverage after 6 month

  6 months

Secondary Outcomes (5)

• Patients satisfaction

  6 months

• Patients Morbidity

  6 months

• presence of dentin hipersensitivity

  6 months

• Pink Esthetic Scores results

  6 months

• presence of dentin hipersensitivity

  6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Coronally Advanced Tunel + ADM (Novomatrix®)

Procedure: Coronally Advanced Tunel + ADM (Novomatrix®)

test group

EXPERIMENTAL

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

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

Interventions

Coronally Advanced Tunel + ADM (Novomatrix®) PROCEDURE

ADM (Novomatrix®) will be used alone

Also known as: Control

Control group

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

ADM in combination with L-Prf will be applied

test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Andres Matteo Pascual La Rocca: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Andres M Pascual, DDS, PhD

CONTACT

+34627725044; alaropas@uax.es

Juan M Aragoneses, MD, DDS, PhD

CONTACT

jaraglam@uax.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization sequence will be carried out using a computer-generated list (StataⓇ v15.1) with a 1:1 allocation ratio according to a block randomization procedure. Allocation concealment will be kept by means of opaque-sealed envelopes that will be opened immediately after the anesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, PhD

Model Details: The present study protocol is a two-arm, randomized controlled clinical trial with a follow-up period of 6 months. The protocol of this study has been prepared according to the SPIRIT 2013 Statement. The study will be conducted at the Universidad Alfonso X el Sabio (UAX). Subjects will be recruited consecutively from the Department of Periodontology of Clinica Universitaria de Odontologia (CUO-UAX). The study will be coordinated by the principal investigator. Patients attending the Department of Periodontology (CUO-UAX) will be consecutively screened for eligibility and included in the study by one team member responsible in recruitment .

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 9, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01