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New treatment option for Gingival Recession, Localized
Official title Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery
ClinicalTrials.gov ID: NCT07430670
What this study is testing
What is Theravex Bioactive Solutions (Tissue Care Plus and Oral)?
Theravex Bioactive Solutions (Tissue Care Plus and Oral) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gingival recession, localized.
Also referred to as Bone Bioactive Liquid (BBL).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.