Gingival Recession, LocalizedNCT07430670
Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery
A study testing Modified Free Gingival Graft (M-FGG) and Theravex Bioactive Solutions (Tissue Care Plus and Oral) in people with Gingival Recession, Localized, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- Modified Free Gingival Graft (M-FGG) and Theravex Bioactive Solutions (Tissue Care Plus and Oral)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2026to 6 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Complutense University of Madrid
Madrid, Madrid, 28040
Andrea Dobos, DMD, +36309532140, andobos@ucm.es
About this study
Official title: Clinical Study on the Efficacy of Theravex Oral and Theravex Tissue Care Plus in Periodontal Surgery" Modified Free Gingival Graft for the Treatment of RT1-RT2: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Gingival Recession, Localized
- Being tested
- Modified Free Gingival Graft (M-FGG), Theravex Bioactive Solutions (Tissue Care Plus and Oral)
- 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)
- Medical subject headings
- Gingival Recession, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Free Gingival Graft (M-FGG)Procedure or surgery
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.
Theravex Bioactive Solutions (Tissue Care Plus and Oral)Drug
Also called Bone Bioactive Liquid (BBL)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Modified Free Gingival Graft (M-FGG); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral) |
| 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. Receives: Procedure: Modified Free Gingival Graft (M-FGG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months post-surgery.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Preoperatively, immediately after surgery, 2 weeks, 1 month, 3 months, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start17 Feb 2026
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Biointelligent Technology Systems SL
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz Alonso, DMD, MD, PHD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430670
- Sponsor's protocol ID
- Theravex
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy of Theravex Oral and Theravex Tissue Care Plus in Periodontal Surgery" Modified Free Gingival Graft for the Treatment of RT1-RT2: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07430670
- Acronym / sponsor ID
- Theravex
- Conditions
- Gingival Recession, Localized
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Biointelligent Technology Systems SL
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theravex Oral and Theravex Tissue Care Plus | Experimental | Procedure: Modified Free Gingival Graft (M-FGG), Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)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 |
| Control Group | Active comparator | Procedure: Modified Free Gingival Graft (M-FGG)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Control Group, Theravex Oral and Theravex Tissue Care Plus |
| Theravex Bioactive Solutions (Tissue Care Plus and Oral)Also: Bone Bioactive Liquid (BBL)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. | Drug | Theravex Oral and Theravex Tissue Care Plus |
Primary outcome
Recession depth reduction
Time frame: 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.
7 secondary outcomes
Recession Depth (RD)
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.
Recession Width (RW)
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.
Keratinized Tissue Width (KTW)
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.
Soft Tissue Thickness (STT)
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.
Microvascular Perfusion (LSPU)
Time frame: Preoperatively, immediately after surgery, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months
Gingival Color Difference (Delta E)
Time frame: Preoperatively, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 1 year
Soft Tissue Volume Change
Time frame: Preoperatively, immediately after surgery, 2 weeks, 1 month, 3 months, 6 months, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariano Sanz Alonso, DMD, MD, PHD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Free Gingival Graft (M-FGG) and Theravex Bioactive Solutions (Tissue Care Plus and Oral) in people with Gingival Recession, Localized, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariano Sanz Alonso, DMD, MD, PHD (913942021, marsan@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession depth reduction (time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.