Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07430670

Clinical Study on the Efficacy of Theravex Oral and Theravex Tissue Care Plus in Periodontal Surgery Modified Free Gingival Graft for RT1-RT2 Gingival Recession: A Randomized Clinical Trial

Led by Universidad Complutense de Madrid · Updated on 2026-02-24

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

Universidad Complutense de Madrid

Lead Sponsor

B

Biointelligent Technology Systems SL

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two new bioactive solutions, Theravex Oral and Theravex Tissue Care Plus, to improve soft tissue healing after periodontal surgery. The study focuses on patients with gingival recession around mandibular incisors undergoing a Modified Free Gingival Graft (M-FGG) technique. This randomized, double-blind trial aims to measure the impact of these solutions on root coverage, tissue gain, color integration, and postoperative pain over a one-year period. Participants are randomly assigned to either the test group receiving the M-FGG surgery combined with Theravex Tissue Care Plus applied to the graft and recipient site, followed by twice-daily rinsing with Theravex Oral for 14 days, or the control group receiving the same surgery with a saline placebo solution and rinsing with a blinded cetylpyridinium chloride solution. The solutions are applied immediately after graft harvesting and prior to graft placement. During the study, participants are followed at 1, 3, 6, and 12 months post-surgery for clinical exams and professional hygiene. Researchers assess outcomes including recession depth reduction, keratinized tissue width, soft tissue thickness, tissue color integration, microvascular perfusion, and soft tissue volume changes using digital 3D scanning, spectrophotometry, ultrasonography, and laser imaging. Patient-reported pain and aesthetic perceptions are also recorded.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy patients aged 18 years or older
  • At least one mandibular incisor with RT1 or RT2 gingival recession needing a free gingival graft
  • Periodontal health with plaque index 20% or less
  • Probing depth 3 mm or less on treated teeth
  • No dental mobility greater than grade 1 on treated teeth
  • Well-defined cementoenamel junction
  • Signed informed consent to participate
Not Eligible

You will not qualify if you...

  • Smoking 10 or more cigarettes per day
  • Previous treatment with Theravex products
  • Untreated parafunctional habits like teeth grinding
  • Restorations that cannot be removed for treatment
  • Pregnant patients or uncertain pregnancy status
  • Uncontrolled systemic diseases, neurological or psychiatric disorders
  • Not attending follow-up visits or not signing informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo a Modified Free Gingival Graft (M-FGG) surgery where a graft is harvested and placed at the treatment site. During surgery, either Theravex Tissue Care Plus or a placebo solution is applied to the graft and recipient site. Immediately after surgery, participants perform a rinse with Theravex Oral or placebo solution.

1 day surgery visit

Treatment

Duration - 14 days

Participants rinse twice daily with Theravex Oral or placebo solution for 14 days following surgery to support healing.

Twice-daily rinsing at home for 14 days

Post-operative Follow-up

Duration - 12 months

Participants attend follow-up visits for clinical examinations, digital 3D scanning, tissue assessments, and professional hygiene to monitor healing and treatment outcomes.

Follow-up visits at 1, 3, 6, and 12 months post-surgery

Trial Site Locations

Total: 1 location

1

Complutense University of Madrid

Madrid, Madrid, Spain, 28040

Actively Recruiting

Loading map...

Research Team

M

Mariano Sanz Alonso, DMD, MD, PHD

A

Andrea Dobos, DMD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Three-Dimensional Digital Evaluation of Soft Tissue Changes ...

Gingival Recession, Localized

Actively Recruiting

1 location

Clinical Evaluation of Tunneled Coronally Advanced Flap Vers...

Gingival Recession, Localized

Actively Recruiting

1 location

Comparing Coronally Advanced Flap and Tunneled Coronally Adv...

Gingival Recession Generalized Moderate

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here