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

NCT07397026 | Active Not Recruiting Phase 1

• 1 other identifier: M0102025OM
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis Stage III

Keywords

Periodontitis; Resveratrol; Nanoparticles; Cox-2; Scaling; root planing; Gingival crevicular fluid; Superoxide dismutase

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level (CAL) as Clinical periodontal parameter

  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

  3 months

Secondary Outcomes (1)

• laboratory evaluation of Cox-2 & SOD in GCF

  3 months

Study Arms (4)

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

NO INTERVENTION

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

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.

Drug: Resveratrol loaded gel

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

PLACEBO COMPARATOR

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 .

Drug: Resveratrol loaded gel

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

OTHER

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 .

Drug: Resveratrol loaded gel

Interventions

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 .

Also known as: (Resveratrol loaded gel ), Resveratrol Loaded Nanoparticles

Group 2(positive control group): includes 12 patients will be treated with Scaling and root planing; Group 3 (placebo group): includes 12 patients will be treated with Resveratrol unloaded gel; Group 4 (Resveratrol Loaded Nanoparticles):12 patients will be injected with Resveratrol loaded gel

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hagar Ahmed Ali Mohammed Elzain: lead
• Mansoura University: collaborator

Study Sites (1)

Faculty of dentistry , Mansoura university

Al Mansurah, DK, 35516, Egypt

Location

Related Publications (9)

• Kornman KS. Controlled-release local delivery antimicrobials in periodontics: Prospects for the future. Journal of periodontology. 1993;64:782-91.

  BACKGROUND

• Goodson J, Haffajee A, Socransky S. Periodontal therapy by local delivery of tetracycline. Journal of Clinical Periodontology. 1979;6(2):83-92.

  BACKGROUND

• Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. Journal of clinical periodontology. 2002;29:22-32.

  BACKGROUND

• Page RC, Kornman KS. The pathogenesis of human periodontitis: an introduction. Periodontology 2000. 1997;14(1):9-11.

  BACKGROUND

• Graves DT, Cochran D. The contribution of interleukin-1 and tumor necrosis factor to periodontal tissue destruction. Journal of periodontology. 2003;74(3):391-401.

  BACKGROUND

• Darveau RP. Periodontitis: a polymicrobial disruption of host homeostasis. Nature reviews microbiology. 2010;8(7):481-90.

  BACKGROUND

• Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nature reviews immunology. 2015;15(1):30-44.

  BACKGROUND

• 2. Socransky SS, Haffajee AD. Dental biofilms: difficult therapeutic targets. Periodontology 2000. 2002;28(1):12-55.

  BACKGROUND

• 1. Hussein MH, Badr BM, Hassan KS, Ibrahim IH. Evaluation of the Effect of Topically Applied Resveratrol Gel as Adjunctive Treatment for Periodontitis. European Journal of General Dentistry. 2024.

  BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical demonstrator faculty of dentistry Mansoura university

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: February 9, 2026
• Study Start: August 9, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

EG (1)