Actively Recruiting
Clinical Study on the Efficacy of Theravex Oral and Theravex Tissue Care Plus in Periodontal Surgery Modified Free Gingival Graft for RT1-RT2 Gingival Recession: A Randomized Clinical Trial
Led by Universidad Complutense de Madrid · Updated on 2026-02-24
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universidad Complutense de Madrid
Lead Sponsor
B
Biointelligent Technology Systems SL
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two new bioactive solutions, Theravex Oral and Theravex Tissue Care Plus, to improve soft tissue healing after periodontal surgery. The study focuses on patients with gingival recession around mandibular incisors undergoing a Modified Free Gingival Graft (M-FGG) technique. This randomized, double-blind trial aims to measure the impact of these solutions on root coverage, tissue gain, color integration, and postoperative pain over a one-year period. Participants are randomly assigned to either the test group receiving the M-FGG surgery combined with Theravex Tissue Care Plus applied to the graft and recipient site, followed by twice-daily rinsing with Theravex Oral for 14 days, or the control group receiving the same surgery with a saline placebo solution and rinsing with a blinded cetylpyridinium chloride solution. The solutions are applied immediately after graft harvesting and prior to graft placement. During the study, participants are followed at 1, 3, 6, and 12 months post-surgery for clinical exams and professional hygiene. Researchers assess outcomes including recession depth reduction, keratinized tissue width, soft tissue thickness, tissue color integration, microvascular perfusion, and soft tissue volume changes using digital 3D scanning, spectrophotometry, ultrasonography, and laser imaging. Patient-reported pain and aesthetic perceptions are also recorded.
CONDITIONS
Brief Title
Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy patients aged 18 years or older
- At least one mandibular incisor with RT1 or RT2 gingival recession needing a free gingival graft
- Periodontal health with plaque index 20% or less
- Probing depth 3 mm or less on treated teeth
- No dental mobility greater than grade 1 on treated teeth
- Well-defined cementoenamel junction
- Signed informed consent to participate
You will not qualify if you...
- Smoking 10 or more cigarettes per day
- Previous treatment with Theravex products
- Untreated parafunctional habits like teeth grinding
- Restorations that cannot be removed for treatment
- Pregnant patients or uncertain pregnancy status
- Uncontrolled systemic diseases, neurological or psychiatric disorders
- Not attending follow-up visits or not signing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a Modified Free Gingival Graft (M-FGG) surgery where a graft is harvested and placed at the treatment site. During surgery, either Theravex Tissue Care Plus or a placebo solution is applied to the graft and recipient site. Immediately after surgery, participants perform a rinse with Theravex Oral or placebo solution.
1 day surgery visit
Duration - 14 days
Participants rinse twice daily with Theravex Oral or placebo solution for 14 days following surgery to support healing.
Twice-daily rinsing at home for 14 days
Duration - 12 months
Participants attend follow-up visits for clinical examinations, digital 3D scanning, tissue assessments, and professional hygiene to monitor healing and treatment outcomes.
Follow-up visits at 1, 3, 6, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Complutense University of Madrid
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
M
Mariano Sanz Alonso, DMD, MD, PHD
A
Andrea Dobos, DMD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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