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NCT Number: NCT07397026

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of dentistry , Mansoura university

Al Mansurah, DK, 35516, Egypt

About this study

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:
  • Plaque Index (PI), according to Silness P. Loe H 1964.
  • Gingival Index (GI), according to Silness P. Loe H 1963.
  • Eastman Interdental Bleeding Index (EIBI), according to Ainamo & Bay 1975 .
  • Clinical Attachment Level (CAL) is measured from cemento enemal junction to base of the pocket.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient 25-55 years.
  • Presence of ≥20 teeth.
  • PPD >3&≤5 mm.
  • The patients are in good systemic health.
  • Patients have not received any periodontal surgery in the areas that will be assessed in the last 6 months

Exclusion criteria

  • Patients with systemic diseases.
  • Pregnant and lactating women.
  • Heavy Smokers and tobacco chewers.
  • Patients do not follow oral hygiene measures.
  • Patients with a known or suspected allergy to any material used in the study.

Treatment and study plan

Resveratrol loaded gel

Drug

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 .

Other names: (Resveratrol loaded gel ), Resveratrol Loaded Nanoparticles

Primary outcomes

  1. Clinical attachment level (CAL) as Clinical periodontal parameter

    Time frame: 3 months

    Patients who are accepted for this study will be screened by periodontal examination and full periodontal charts. Proper Diagnosis of the stages of periodontitis will be based on the new classification proposed in 2017.

    Clinical attachment level (CAL) as Clinical periodontal parameter in mm

Secondary outcomes

  1. laboratory evaluation of Cox-2 & SOD in GCF

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Hagar Ahmed Ali Mohammed Elzain

Other

Collaborators

  • Mansoura University

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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