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

Hagar Ahmed Ali Mohammed Elzain

Status and phase: Active, not recruiting; Phase 1

Conditions: Periodontitis Stage III

Treatments: Drug: Resveratrol loaded gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07397026

M0102025OM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups, including a placebo group

Group 1 (negative control group): includes 12 periodontally healthy subjects

No Intervention group

Description:

Healthy 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. * 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 . no injection of Resveratrol Loaded Nanoparticles .

Group 2(positive control group): includes 12 patients will be treated with Scaling and root planing

Sham Comparator group

Description:

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 periodontal parameters, including: 1. Plaque Index (PI) . 2. Gingival Index(GI) . 3. Eastman Interdental Bleeding Index (EIBI) . 4. Clinical Attachment Level (CAL) . 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 . * 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 . After proper and accurate examination and diagnosis, full mouth supra- and subgingival SRP will be performed with ultrasonic tips and Gracey curettes . patients will receive oral hygiene instructions.

Treatment:

Drug: Resveratrol loaded gel

Group 3 (placebo group): includes 12 patients will be treated with Resveratrol unloaded gel

Placebo Comparator group

Description:

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 periodontal parameters, including: 1. PI . 2. GI . 3. EIBI . 4. CAL . 5. PPD. * 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 . After diagnosis, full mouth supra- and subgingival SRP will be performed with ultrasonic tips and Gracey curettes . patients will receive oral hygiene instructions. After completion of SRP, RES unloaded gel will be injected as placebo gel in using a syringe with a blunt cannula until the pocket will be completely filled. the Patients will be instructed to avoid chewing hard, eating any sticky foods for several hours. No intervention of Resveratrol Loaded Nanoparticles .

Treatment:

Drug: Resveratrol loaded gel

Group 4 (Resveratrol Loaded Nanoparticles):12 patients will be injected with Resveratrol loaded gel

Other group

Description:

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 periodontal parameters, including: 1. PI . 2. GI . 3. EIBI . 4. CAL . 5. PPD. * 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 . After diagnosis, full mouth supra- and subgingival SRP will be performed with ultrasonic tips and Gracey curettes . patients will receive oral hygiene instructions. After completion of SRP, Resveratrol loaded nanoparticles gel will be injected in the selected periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. there is intervention by injection of Resveratrol Loaded Nanoparticles inside the pocket .

Treatment:

Drug: Resveratrol loaded gel