This clinical study assesses the efficacy of two novel bioactive solutions, Theravex Oraland Theravex Tissue Care Plus, in enhancing soft tissue healing after periodontalsurgery. The study focuses on patients undergoing a Modified Free Gingival Graft (M-FGG)technique to treat gingival recessions around mandibular incisors. Participants arerandomly assigned to a test group receiving the Theravex treatment or a control groupreceiving a saline placebo. The primary goal is to measure the impact of these solutionson root coverage and other key outcomes, such as tissue gain, color integration, andpostoperative 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:
- 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.
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.
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 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.
Other Name: Bone Bioactive Liquid (BBL)
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.
Complutense University of Madrid
Madrid, Madrid, Spain
Investigator: Andrea Dobos, DMD
Contact: +36309532140
andobos@ucm.es
Mariano Sanz Alonso, DMD, MD, PHD
913942021
marsan@ucm.es
Andrea Dobos, DMD
+36309532140
andobos@ucm.es
Mariano Sanz Alonso, DMD, MD, PHD, Principal Investigator
Universidad Complutense de Madrid