Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Complutense de Madrid

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

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universidad Complutense de Madrid

Lead sponsor

Biointelligent Technology Systems SL

Collaborator