Coronally Advanced Tunnel Combined With Xenogenic Dermal Matrix and L-PRF (CAF+XADM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession; Gingival Recession, Localized; Mucogingival Defects
• Intervention / Treatment: Procedure: Coronally Advanced Tunel + ADM (Novomatrix®); Procedure: Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Andres M Pascual, DDS, PhD; Phone Number: +34627725044; Email: alaropas@uax.es
• Study Contact Backup: Name: Juan M Aragoneses, MD, DDS, PhD; Email: jaraglam@uax.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Coronally Advanced Tunel + ADM (Novomatrix®)	Procedure: Coronally Advanced Tunel + ADM (Novomatrix®); ADM (Novomatrix®) will be used alone; Other Names: Control
Experimental: test group; Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF	Procedure: Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF; ADM in combination with L-Prf will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root Coverage	Percentage of root coverage after 6 month	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Morbidity	Post Operative pain measured with visual analogue scale where the level of pain will be assessed according to the grades from 0 to 10.	6 months
presence of dentin hipersensitivity	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.	6 months
presence of dentin hipersensitivity	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.	6 months
Patients satisfaction	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.	6 months
Pink Esthetic Scores results	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.	6 months

Collaborators and Investigators

• Sponsor: Andres Matteo Pascual La Rocca

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: acellular dermal matrix; coronally advenced tunnel
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: 2024 _ 4/269; ORF42414 (Other Grant/Funding Number: Oral Reconstruction Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No