Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.
- Conditions
- Periodontal DiseasesPeriodontal PocketPeriodontal Attachment Loss
- Interventions
- Procedure: Lipo-Curcumin gel + SRPProcedure: Lipo gel + SRPProcedure: Discharged Gel + SRPProcedure: SRP alone
- Registration Number
- NCT06624241
- Lead Sponsor
- G. d'Annunzio University
- Brief Summary
The aim of the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig (SRP) in association with lipo-curcumin gel (LC) respect SRP+ lipo-gel (L), SRP+ discharged (D) gel and SRP alone.
This study will be designed as a randomized clinical trial of 12-month duration. A total of 40 patients will be recruited and randomly equally distributed into 4 groups: an experimental group treated with SRP + LC, a first control group treated with SRP + L, a second control group treated with SRP+D and a third control group SRP alone.
Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following SRP, experimental and control sites will be randomly chosen. The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate. In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate, in the third control group SRP alone will be performed.
Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Patients with a diagnosis of periodontitis stage III (grades A to C)
- on-smokers or former smokers who quit at least 1 year ago, and had not received any periodontal treatment in the 3 months prior to recruitment
- FMPS < 20% at baseline
- Furcation not involved
- Not Pregnant or Lactating
- Signed informed consent
- Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C>7%, rheumatoid arthritis or any form of immunosuppression
- Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment
- Chronic intake of NSAIDs or steroids, currently
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lipo-Curcumin gel + SRP Lipo-Curcumin gel + SRP After SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. Lipo gel + SRP Lipo gel + SRP After SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate Discharged Gel + SRP Discharged Gel + SRP After SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate SRP alone SRP alone SRP alone will be performed.
- Primary Outcome Measures
Name Time Method Pocket Probing Depth (PPD) 12 months Distance between the gingival margin and the bottom of the pocket.
- Secondary Outcome Measures
Name Time Method Clinical Attachment Level (CAL) 12 months Distance between the CEJ and the bottom of the pocket
Gingival Recession (GR) 12 months Distance between the CEJ and the gingival margin.
Full Mouth Plaque Score 12 months Index that evaluates the general presence of bacterial plaque for all teeth. Through the passage of the probe, the presence of plaque deposits is reported for 4 surfaces for each tooth. A ratio is made between the contaminated surfaces and the total surfaces investigated to obtain a percentage value.
Full Mouth Bleeding Score 12 months Index that evaluates the general presence of bleeding for all teeth. Through the insertion of a periodontal probe, the presence of bleeding on probing is signaled for 4 sites for each tooth. A ratio is made between the bleeding sites and the total sites investigated to obtain a percentage value.
Trial Locations
- Locations (1)
G. d'Annunzio University
🇮🇹Chieti, CH, Italy