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| Name | Class |
|---|---|
| Biointelligent Technology Systems SL | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariano Sanz Alonso, DMD, MD, PHD | Contact | 913942021 | marsan@ucm.es | |
| Andrea Dobos, DMD | Contact | +36309532140 | andobos@ucm.es |
| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz Alonso, DMD, MD, PHD | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complutense University of Madrid | Recruiting | Madrid | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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. |
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| 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. |
| D055093 |
| Periodontal Atrophy |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |