Health TrialsbyHealthPanel

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

ConditionsGingival RecessionGingival Recession, LocalizedMucogingival Defects
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndres Matteo Pascual La Rocca

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coronally Advanced Tunel + ADM (Novomatrix®)

    Procedure/Surgery

    ADM (Novomatrix®) will be used alone

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

    Procedure/Surgery

    ADM in combination with L-Prf will be applied

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: test groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Root Coverage

Percentage of root coverage after 6 month

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
6 months
4

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.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andres Matteo Pascual La Rocca

Lead sponsor

Alfonso X El Sabio University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: