RecruitingNot ApplicableNCT07430670

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

Sponsor

Universidad Complutense de Madrid

Enrollment

30 participants

Start Date

Feb 17, 2026

Study Type

INTERVENTIONAL

Conditions

Gingival Recession, Localized

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria7

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.

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Interventions

PROCEDUREModified Free Gingival Graft (M-FGG)

The surgical procedure is performed under local anesthesia. It begins with an intrasulcular incision at the gingival margin of the recession, followed by 2 mm-long horizontal incisions at the cementoenamel junction (CEJ) and diverging vertical releasing incisions. A thin partial-thickness flap is raised and excised to prepare the recipient area. A connective tissue pedicle flap is then outlined apical to the exposed root, dissected from the periosteum, flipped, and anchored over the root surface using absorbable sutures. Subsequently, a free gingival graft (1.5-2 mm thick) is harvested from the palatal premolar/molar area. This graft is placed over the recipient site and secured to the periosteum with simple interrupted and cross mattress sutures to ensure complete stability.

DRUGTheravex Bioactive Solutions (Tissue Care Plus and Oral)

Active Ingredients: A novel bioactive saline solution containing calcium chloride and magnesium dichloride hexahydrate. Intraoperative Application: Immediately after harvesting the free gingival graft (1.5-2 mm thickness), 0.5 ml of Theravex Tissue Care Plus is applied to the graft and left to soak for 5 minutes. Recipient Site Treatment: Before placing the graft, 0.5 ml of the solution is applied directly to the prepared recipient site. Postoperative Protocol: Patients perform an immediate post-surgical rinse with 5 ml of Theravex Oral for 30 seconds. Starting the day after surgery, patients rinse twice daily with Theravex Oral for a duration of 2 weeks.