NCT07397026

Clinical and Laboratory Evaluation of Resveratrol Loaded Nanoparticles in the Treatment of Periodontitis: A Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hagar Ahmed Ali Mohammed Elzain · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The Aim of this study is to test the effectiveness of locally applied resveratrol as an adjunct to scaling and root planing in the treatment of periodontitis (primary outcome) . Also to assess the level of COX-2 and superoxide dismutase (SOD) in the gingival crevicular fluid samples using the commercially available kits.

Detailed description

Patients who are accepted for this study will be screened by a comprehensive periodontal examination and full periodontal charts. Proper Diagnosis of the stages of periodontitis will be based on the new classification proposed in 2017 AAP World Workshop. * Clinical periodontal parameters, including: 1. Plaque Index (PI), according to Silness P. Loe H 1964. 2. Gingival Index (GI), according to Silness P. Loe H 1963. 3. Eastman Interdental Bleeding Index (EIBI), according to Ainamo \& Bay 1975 . 4. Clinical Attachment Level (CAL) is measured from cemento enemal junction to base of the pocket. 5. Probing Pocket Depth(PPD) is measured from free gingival margin to base of the pocket. ALL these parameters will be assessed at baseline and after 3 months after treatment for groups 2, 3 and 4 while at baseline only for group 1. * GCF samples will be collected using sterile paper strips and analyzed using the commercially available kits for the assessment of the level of COX-2 and SOD at baseline and after 3 months after treatment for groups 2, 3 and 4 while at baseline only for group 1. After proper and accurate examination and diagnosis, full mouth supra- and subgingival SRP will be performed with ultrasonic tips and Gracey curettes (Hu-Friedy, Chicago, United States) and an ultrasonic device (Minipiezon, EMS \[Electro Medical System\], Le Sentier, Switzerland). All patients will receive oral hygiene instructions. After completion of SRP, RES loaded gel will be injected in the selected periodontal pocket of the test group (group 4) while RES unloaded gel will be injected as placebo gel in group 3 using a syringe with a blunt cannula until the pocket will be completely filled. After atraumatic application of the local drug delivery system, the Patients will be instructed to avoid chewing hard, eating any sticky foods for several hours.

Conditions

• Periodontitis Stage III

Interventions

Type	Name	Description
DRUG	Resveratrol loaded gel	Locally injection of Resveratrol Loaded Nanoparticles in patients with stage II periodontitis according to 2017 classification in group 4 only while group 3 will be injected with placebo also group 2 will be treated with only SRP but group 1 is the healthy group ,these participants will only be screened by a comprehensive periodontal examination and full periodontal charts. Proper Diagnosis of the stages of periodontitis will be based on the new classification proposed in 2017 AAP World Workshop and no intervention will be done .

Timeline

• Start date: 2025-08-09
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Egypt