Actively Recruiting
Clinical Evaluation of Lipo-Curcumin Gel with Scaling and Root Planing for Treating Stage III Periodontitis: A Randomized Controlled Trial
Led by G. d'Annunzio University · Updated on 2024-10-02
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Scaling and Root Planing (SRP) combined with lipo-curcumin gel compared to SRP with other gels or SRP alone for treating Stage III periodontitis. This randomized clinical trial aims to compare clinical and radiographic outcomes over 12 months. The study involves 40 patients divided into four groups to assess different treatment combinations and their effects on periodontal disease. Each participant will receive SRP using ultrasonic scalers and hand instruments under local anesthesia to clean the periodontal pockets. After SRP, the treatment groups will have their pockets filled with either lipo-curcumin gel, lipo gel, discharged gel, or no additional gel, all sealed with cyanoacrylate. Treatments are applied carefully to preserve soft tissue stability. The trial will last 12 months with follow-up treatments and assessments. Participants will undergo clinical examinations before treatment, and again at 6 and 12 months. These assessments include measuring Pocket Probing Depth, Clinical Attachment Level, Gingival Recession, Full-Mouth Plaque Score, and Bleeding on Probing. The evaluations are conducted by an examiner who does not know which treatment was given. The study will monitor these outcomes to compare the different treatment effects over the one-year period.
CONDITIONS
Brief Title
Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a diagnosis of periodontitis stage III (grades A to C)
- Non-smokers or former smokers who quit at least 1 year ago
- No periodontal treatment in the 3 months prior to recruitment
- Full mouth plaque score (FMPS) less than 20% at baseline
- Furcation not involved
- Not pregnant or lactating
- Signed informed consent
You will not qualify if you...
- Presence of uncontrolled systemic diseases affecting treatment outcomes (e.g., diabetes mellitus with HbA1C >7%, rheumatoid arthritis, immunosuppression)
- Received systemic or local antibiotic therapy within 6 weeks before enrollment
- Chronic intake of NSAIDs or steroids currently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with follow-up assessments up to 12 months
Participants receive scaling and root planing (SRP) followed by the application of one of several gels or SRP alone to treat stage III periodontitis.
1 treatment visit and several follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
G. d'Annunzio University
Chieti, CH, Italy, 66100
Actively Recruiting
Research Team
M
Michele Paolantonio, DDS, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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