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

Official title

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

Overview

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.

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.

Interventions

• 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 surfac
• 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 p

Primary outcome measures

• Recession depth reduction [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-surgery.]

Secondary outcome measures (7)

• Recession Depth (RD) [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.]
• Recession Width (RW) [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.]
• Keratinized Tissue Width (KTW) [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.]
• Soft Tissue Thickness (STT) [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.]
• Microvascular Perfusion (LSPU) [Time frame: Preoperatively, immediately after surgery, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months]
• Gingival Color Difference (Delta E) [Time frame: Preoperatively, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 1 year]
• Soft Tissue Volume Change [Time frame: Preoperatively, immediately after surgery, 2 weeks, 1 month, 3 months, 6 months, and 12 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Complutense University of Madrid — Madrid

Identifiers

NCT: NCT07430670 · Theravex

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗