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

NCT07430670 | Recruiting

• 1 other identifier: Theravex
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Recession, Localized

Keywords

Gingiva Recession; Modified Free Gingival Graft (M-FGG); Theravex (Oral and Tissue Care Plus); Bone Bioactive Liquid; Root Coverage; Soft Tissue Healing; Neovascularization; Spectrophotometry; Ultrasonography; Randomized Clinical Trial (RCT)

Outcome Measures

Primary Outcomes (1)

• Recession depth reduction

  Recession Depth reduction is a calculated variable. It is determined by subtracting the Recession Depth measured at the follow-up visits from the Baseline (BL) Recession Depth (RD reduction = BL RD - Follow-up RD). Measurements are taken mid-buccally.

  Baseline, 1 month, 3 months, 6 months, and 12 months post-surgery.

Secondary Outcomes (7)

• Recession Depth (RD)

  Baseline, 1 month, 3 months, 6 months, and 12 months.

• Recession Width (RW)

  Baseline, 1 month, 3 months, 6 months, and 12 months.

• Keratinized Tissue Width (KTW)

  Baseline, 1 month, 3 months, 6 months, and 12 months.

• Soft Tissue Thickness (STT)

  Baseline, 1 month, 3 months, 6 months, and 12 months.

• Microvascular Perfusion (LSPU)

  Preoperatively, immediately after surgery, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months

Study Arms (2)

Theravex Oral and Theravex Tissue Care Plus

EXPERIMENTAL

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

Procedure: Modified Free Gingival Graft (M-FGG); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)

Control Group

ACTIVE COMPARATOR

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.

Procedure: Modified Free Gingival Graft (M-FGG)

Interventions

Modified Free Gingival Graft (M-FGG) PROCEDURE

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.

Control Group; Theravex Oral and Theravex Tissue Care Plus

Theravex Bioactive Solutions (Tissue Care Plus and Oral) DRUG

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.

Also known as: Bone Bioactive Liquid (BBL)

Theravex Oral and Theravex Tissue Care Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Biointelligent Technology Systems SL: collaborator

Study Sites (1)

Complutense University of Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Gingival Recession; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariano Sanz Alonso, DMD, MD, PHD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariano Sanz Alonso, DMD, MD, PHD

CONTACT

913942021; marsan@ucm.es

Andrea Dobos, DMD

CONTACT

+36309532140; andobos@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)