Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.

Clinical Evaluation of Lipo-Curcumin Gel in Association with SRP for the Treatment of Stage III Periodontitis: a Randomized and Controlled Clinical Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss
• Intervention / Treatment: Procedure: Lipo-Curcumin gel + SRP; Procedure: Lipo gel + SRP; Procedure: Discharged Gel + SRP; Procedure: SRP alone

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Paolantonio, DDS, MD; Phone Number: 3395204073; Email: michelepaolantonio@gmail.com

Study Locations

• Italy
  • CH
    • Chieti, CH, Italy, 66100
      • Recruiting
      • G. d'Annunzio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SRP alone; SRP alone will be performed.	Procedure: SRP alone; The pocket defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed.
Experimental: Lipo-Curcumin gel + SRP; After SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate.	Procedure: Lipo-Curcumin gel + SRP; The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo- Curcumin gel. The pocket will be sealed with cyanoacrylate.
Active Comparator: Lipo gel + SRP; After SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate	Procedure: Lipo gel + SRP; The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo gel. The pocket will be sealed with cyanoacrylate.
Active Comparator: Discharged Gel + SRP; After SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate	Procedure: Discharged Gel + SRP; The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of discharged gel. The pocket will be sealed with cyanoacrylate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket Probing Depth (PPD)	Distance between the gingival margin and the bottom of the pocket.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Level (CAL)	Distance between the CEJ and the bottom of the pocket	12 months
Gingival Recession (GR)	Distance between the CEJ and the gingival margin.	12 months
Full Mouth Plaque Score	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.	12 months
Full Mouth Bleeding Score	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.	12 months

Collaborators and Investigators

• Sponsor: G. d'Annunzio University
• Investigators: Study Chair: Michele Paolantonio, DDS, MD, University 'G. D'Annunzio' of Chieti

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Periodontitis; SRP; Liposome; Curcumin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Atrophy; Periodontitis; Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 12062024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No