An interventional study of Modified Free Gingival Graft (M-FGG) and Theravex Bioactive Solutions (Tissue Care Plus and Oral) in Gingival Recession, Localized, sponsored by Universidad Complutense de Madrid. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
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:
Outcomes and Follow-up:
The primary outcome is the reduction of recession depth at 12 months. Secondary outcomes include:
Participants are followed at regular intervals (1, 3, 6, and 12 months post-surgery) for clinical examinations and professional hygiene.
426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 390 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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)
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.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-surgery.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Preoperatively, immediately after surgery, 2 weeks, 1 month, 3 months, 6 months, and 12 months.
Plan to share: No
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