Gingival Recession, Localized
Conditions
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)
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.
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
PROCEDUREModified 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.
Sponsors
Universidad Complutense de Madrid
Biointelligent Technology Systems SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recession depth reduction | Baseline, 1 month, 3 months, 6 months, and 12 months post-surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recession Depth (RD) | Baseline, 1 month, 3 months, 6 months, and 12 months. | 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. |
| Recession Width (RW) | Baseline, 1 month, 3 months, 6 months, and 12 months. | 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. |
| Keratinized Tissue Width (KTW) | Baseline, 1 month, 3 months, 6 months, and 12 months. | 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. |
| Soft Tissue Thickness (STT) | Baseline, 1 month, 3 months, 6 months, and 12 months. | 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). |
| Microvascular Perfusion (LSPU) | Preoperatively, immediately after surgery, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months | Blood supply and superficial vascular network visualization quantified in Laser Speckle Perfusion Units (LSPU) using Laser Speckle Contrast Imaging (LSCI). |
| Gingival Color Difference (Delta E) | Preoperatively, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 1 year | 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. |
| Soft Tissue Volume Change | Preoperatively, immediately after surgery, 2 weeks, 1 month, 3 months, 6 months, and 12 months. | Volumetric changes of the soft tissue dimensions analyzed through the comparison of Surface Tessellation Language (STL) files obtained from digital intraoral scans. |
Countries
Spain
Contacts
CONTACTMariano Sanz Alonso, DMD, MD, PHD
CONTACTAndrea Dobos, DMD
PRINCIPAL_INVESTIGATORMariano Sanz Alonso, DMD, MD, PHD
Universidad Complutense de Madrid
Outcome results
None listed