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

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.

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.