Theravex Oral and Theravex Tissue Care Plus to improve healing after mucogingival surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind trial at the Complutense University of Madrid enrolls adults with RT1–RT2 gingival recessions on mandibular incisors who require a modified free gingival graft (M-FGG). Participants are randomly assigned to receive either Theravex Tissue Care Plus applied to the graft and recipient site plus 14 days of twice-daily Theravex Oral rinses, or the same surgical protocol with a blinded saline placebo. The primary outcome is reduction in recession depth at 12 months, and secondary outcomes include keratinized tissue width, soft tissue thickness, volumetric 3D changes, tissue color integration by spectrophotometry, vascularization by Laser Speckle Contrast Imaging, and postoperative pain. Follow-up includes clinical exams and digital imaging over a one-year period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Complutense University of Madrid
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Mariano Sanz Alonso, DMD, MD, PHD — Universidad Complutense de Madrid
• Study coordinator: Mariano Sanz Alonso, DMD, MD, PHD
• Email: marsan@ucm.es
• Phone: 913942021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.