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

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession, Localized
• Intervention / Treatment: Procedure: Modified Free Gingival Graft (M-FGG); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)

Detailed Description

Background and Rationale:

Gingival recession is a common condition often leading to aesthetic concerns and dentin hypersensitivity. While Free Gingival Graft (FGG) is a standard procedure to halt recession, it often lacks aesthetic predictability. This study investigates a novel Bone Bioactive Liquid (BBL) solution, containing calcium chloride and magnesium dichloride hexahydrate, which has shown preclinical advantages in hard and soft tissue regeneration.

Study Design and Methodology:

This is a randomized, double-blind clinical trial conducted at the Complutense University of Madrid. Subjects with at least one RT1-RT2 gingival recession around mandibular incisors are recruited based on specific inclusion and exclusion criteria, including periodontal health and non-smoking status.

Intervention:

• Test Group: Receives M-FGG surgery combined with Theravex Tissue Care Plus applied to the graft and recipient site, followed by 14 days of twice-daily rinsing with Theravex Oral.
• Control Group: Receives the same surgical procedure using a blinded saline placebo.

Outcomes and Follow-up:

The primary outcome is the reduction of recession depth at 12 months. Secondary outcomes include:

• Clinical parameters (keratinized tissue width, probing depth, etc.).
• Volumetric changes analyzed via digital 3D scanning.
• Tissue color integration measured by spectrophotometry.
• Vascularization assessed through Laser Speckle Contrast Imaging (LSCI).
• Soft tissue thickness evaluated via ultrasonography.
• Patient-reported outcomes (PROMS) focusing on pain perception and aesthetics.

Participants are followed at regular intervals (1, 3, 6, and 12 months post-surgery) for clinical examinations and professional hygiene.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Dobos, DMD; Phone Number: +36309532140; Email: andobos@ucm.es
• Study Contact Backup: Name: Mariano Sanz Alonso, DMD, MD, PHD; Phone Number: 913942021; Email: marsan@ucm.es

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • Complutense University of Madrid
      • Contact: Andrea Dobos, DMD; Phone Number: +36309532140; Email: andobos@ucm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Modified 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.; Drug: Theravex 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.; Other Names: Bone Bioactive Liquid (BBL)
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.	Procedure: Modified 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recession Depth (RD)	This clinical parameter measures the exposure of the root surface by calculating the distance from the cemento-enamel junction (CEJ) to the gingival margin. Measurements are performed mid-buccally with a UNC-15 peridontal probe on the teeth receiving treatment.	Baseline, 1 month, 3 months, 6 months, and 12 months.
Recession Width (RW)	This parameter measures the horizontal extent of the root exposure. The width is measured at the level of the cemento-enamel junction (CEJ) with a UNC-15 periodontal probe.	Baseline, 1 month, 3 months, 6 months, and 12 months.
Keratinized Tissue Width (KTW)	The width of the keratinized gingiva is measured from the gingival margin to the mucogingival junction (MGJ) mid-buccally with a UNC-15 periodontal probe.	Baseline, 1 month, 3 months, 6 months, and 12 months.
Soft Tissue Thickness (STT)	Gingival thickness measured in millimeters using a dental ultrasound device (Pirop Echoson). Measurements are taken at the mid-buccal aspect at standardized points: 1 mm apical to the original marginal gingiva (Baseline) and at 1 mm, 2 mm, and 3 mm apical to the new marginal gingiva (postoperatively).	Baseline, 1 month, 3 months, 6 months, and 12 months.
Microvascular Perfusion (LSPU)	Blood supply and superficial vascular network visualization quantified in Laser Speckle Perfusion Units (LSPU) using Laser Speckle Contrast Imaging (LSCI).	Preoperatively, immediately after surgery, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months
Gingival Color Difference (Delta E)	Measurement of color coordinates (L, a, b) using a reflectance spectrophotometer. Delta E is calculated to determine the chromatic tissue integration between the treated area and adjacent healthy tissue.	Preoperatively, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 1 year
Soft Tissue Volume Change	Volumetric changes of the soft tissue dimensions analyzed through the comparison of Surface Tessellation Language (STL) files obtained from digital intraoral scans.	Preoperatively, immediately after surgery, 2 weeks, 1 month, 3 months, 6 months, and 12 months.

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Biointelligent Technology Systems SL
• Investigators: Principal Investigator: Mariano Sanz Alonso, DMD, MD, PHD, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasonography; Root Coverage; Neovascularization; Spectrophotometry; Randomized Clinical Trial (RCT); Soft Tissue Healing; Gingiva Recession; Modified Free Gingival Graft (M-FGG); Theravex (Oral and Tissue Care Plus); Bone Bioactive Liquid
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Gingival Diseases; Metaplasia; Pathological Conditions, Signs and Symptoms; Gingival Recession; Neovascularization, Pathologic
• Other Study ID Numbers: Theravex

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No