Theravex Oral and Theravex Tissue Care Plus to improve healing after mucogingival surgery
Clinical Study on the Efficacy of Theravex Oral and Theravex Tissue Care Plus in Periodontal Surgery" Modified Free Gingival Graft for the Treatment of RT1-RT2: A Randomized Clinical Trial
We will test if applying Theravex Tissue Care Plus during a modified free gingival graft and rinsing with Theravex Oral afterward helps adults with lower-front gum recession heal faster and get better root coverage than a saline placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07430670 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Healthy adults (≥18) with at least one RT1–RT2 recession on a mandibular incisor, shallow probing depths (≤3 mm), low plaque levels, and willingness to attend scheduled follow-ups are the ideal candidates.
Not a fit: Smokers of ≥10 cigarettes/day, pregnant patients, those with uncontrolled systemic disease, untreated parafunctional habits, or incompatible dental restorations are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the treatment could produce better root coverage, increased tissue thickness and color match, and less postoperative pain after gum graft surgery.
How similar studies have performed: Preclinical data for the Bone Bioactive Liquid show promising effects on hard and soft tissue regeneration, but clinical evidence for these specific Theravex solutions in mucogingival surgery is limited and the approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid, Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.