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Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery

RecruitingNAAges 18 Years - anyAllUniversidad Complutense de Madrid
NCT07430670 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical study assesses the efficacy of two novel bioactive solutions, Theravex Oral and Theravex Tissue Care Plus, in enhancing soft tissue healing after periodontal surgery. The study focuses on patients undergoing a Modified Free Gingival Graft (M-FGG) technique to treat gingival recessions around mandibular incisors. Participants are randomly assigned to a test group receiving the Theravex treatment or a control group receiving a saline placebo. The primary goal is to measure the impact of these solutions on root coverage and other key outcomes, such as tissue gain, color integration, and postoperative pain, over a one-year period.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Healthy patients aged ≥ 18 years. * Patients with at least one mandibular incisor presenting a gingival recession RT1-RT2 and requiring a free gingival graft. * Periodontal health in either an intact or reduced periodontium (Chapple et al., 2018) with a plaque index ≤ 20% (O'Leary et al., 1972). * Initial probing depth ≤ 3 mm in the treated teeth. * No dental mobility (grade ≤ 1) in the treated teeth. * Well-defined CEJ * Agreement to take part in this study (signed informed consent). Exclusion Criteria: * Smokers ≥10 cigarettes/day. * Patients treated with Theravex \[IS1.1\]\[ma1.2\]previously. * Untreated parafunctional habits. * Restorations that cannot be removed for proper treatment. * Pregnant patients or cases with uncertain pregnancy status (self-reported). * Patients with uncontrolled systemic diseases, neurological, psychiatric disorders, or other known conditions capable of influencing the results of the study. * Patients not attending follow-ups or not signing informed consent.
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What it tests

  • Modified Free Gingival Graft (M-FGG)
  • Theravex Bioactive Solutions (Tissue Care Plus and Oral)
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Where

1 site
Complutense University of Madrid
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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