NCT07430670 Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery
| NCT ID | NCT07430670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Complutense de Madrid |
| Condition | Gingival Recession, Localized |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2027-07-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-02-17 with a primary completion date of 2027-07-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Mariano Sanz Alonso, DMD, MD, PHD
PRINCIPAL INVESTIGATOR
Universidad Complutense de Madrid
Frequently Asked Questions
Who can join the NCT07430670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gingival Recession, Localized. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07430670 currently recruiting?
Yes, NCT07430670 is actively recruiting participants. Contact the research team at marsan@ucm.es for enrollment information.
Where is the NCT07430670 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07430670 clinical trial?
NCT07430670 is sponsored by Universidad Complutense de Madrid. The principal investigator is Mariano Sanz Alonso, DMD, MD, PHD at Universidad Complutense de Madrid. The trial plans to enroll 30 participants.