Gingival RecessionPhase 4CAF+XADMNCT06634043
Coronally Advanced Tunnel Combined With Xenogenic Dermal Matrix and L-PRF
A Phase 4 study testing Coronally Advanced Tunel + ADM (Novomatrix®) and Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF in people with Gingival Recession and Gingival Recession, Localized, run by Andres Matteo Pascual La Rocca.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Gingival Recession, Localized, Mucogingival Defects
- What is being tested?
- Coronally Advanced Tunel + ADM (Novomatrix®) and Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 30 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Juan M Aragoneses, MD, DDS, PhD contact
About this study
Official 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
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.
Read more
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.
- Being tested
- Coronally Advanced Tunel + ADM (Novomatrix®), Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF
- Keywords
- acellular dermal matrix, coronally advenced tunnel
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally Advanced Tunel + ADM (Novomatrix®)Procedure or surgery
Also called Control
ADM (Novomatrix®) will be used alone
Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRFProcedure or surgery
ADM in combination with L-Prf will be applied
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Coronally Advanced Tunel + ADM (Novomatrix®) Receives: Procedure: Coronally Advanced Tunel + ADM (Novomatrix®) |
| test group | Experimental | Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF Receives: Procedure: Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Coverage
Percentage of root coverage after 6 month
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Apr 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 .
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andres Matteo Pascual La Rocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andres Matteo Pascual La Rocca, Alfonso X El Sabio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634043
- Sponsor's protocol ID
- 2024 _ 4/269
- Other IDs
- ORF42414
- Acronym
- CAF+XADM
- Status last verified
- Jan 2025
- First submitted
- 26 Sep 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06634043
- Acronym / sponsor ID
- CAF+XADM / 2024 _ 4/269
- Keywords
- acellular dermal matrix, coronally advenced tunnel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Andres Matteo Pascual La RoccaUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Coronally Advanced Tunel + ADM (Novomatrix®)Coronally Advanced Tunel + ADM (Novomatrix®) |
| test group | Experimental | Procedure: Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRFCoronally Advanced Tunel + ADM (Novomatrix®) + L-PRF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronally Advanced Tunel + ADM (Novomatrix®)Also: ControlADM (Novomatrix®) will be used alone | Procedure or surgery | Control group |
| Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRFADM in combination with L-Prf will be applied | Procedure or surgery | test group |
Primary outcome
Root Coverage
Time frame: 6 months
Percentage of root coverage after 6 month
5 secondary outcomes
Patients satisfaction
Time frame: 6 months
Patients Morbidity
Time frame: 6 months
presence of dentin hipersensitivity
Time frame: 6 months
Pink Esthetic Scores results
Time frame: 6 months
presence of dentin hipersensitivity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan M Aragoneses, MD, DDS, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coronally Advanced Tunel + ADM (Novomatrix®) and Coronally Advanced Tunel + ADM (Novomatrix®) + L-PRF in people with Gingival Recession and Gingival Recession, Localized, run by Andres Matteo Pascual La Rocca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andres M Pascual, DDS, PhD (+34627725044, alaropas@uax.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Coverage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.