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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Spain
Complutense University of Madrid
RECRUITING
Madrid
Contact Information
Primary
Mariano Sanz Alonso, DMD, MD, PHD
marsan@ucm.es
913942021
Backup
Andrea Dobos, DMD
andobos@ucm.es
+36309532140
Time Frame
Start Date: 2026-02-17
Estimated Completion Date: 2027-07-06
Participants
Target number of participants: 30
Treatments
Experimental: Theravex Oral and Theravex Tissue Care Plus
Subjects receive a Modified Free Gingival Graft (M-FGG). Immediately after graft harvesting, 0.5 ml of Theravex Tissue Care Plus is applied to the graft for 5 minutes. Before graft placement, 0.5 ml of the solution is applied to the recipient site. Post-surgically, patients rinse with 5 ml of Theravex Oral for 30 seconds immediately after surgery, followed by twice-daily rinsing for 14 days
Active_comparator: Control Group
Subjects receive the same Modified Free Gingival Graft (M-FGG) surgical procedure. In place of the active agent, the graft is submerged in a blinded saline solution (placebo), and the recipient site is irrigated with the same placebo. Post-surgically, patients rinse with a blinded 0.05% cetylpyridinium chloride solution twice daily for 2 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Biointelligent Technology Systems SL
Leads: Universidad Complutense de Madrid

This content was sourced from clinicaltrials.gov