About this trial
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
Qualifiers
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.
Disqualifiers
Smokers ≥10 cigarettes/day.
Patients treated with Theravex [IS1.1][ma1.2]previously.
Untreated parafunctional habits.
Restorations that cannot be removed for proper treatment.
Trial design
Treatments tested in this trial
- Modified Free Gingival Graft (M-FGG)
- Theravex Bioactive Solutions (Tissue Care Plus and Oral)
Treatment groups
Sponsors and collaborators
Universidad Complutense de Madrid
Lead sponsor
Biointelligent Technology Systems SL
Collaborator