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Periodontitis Stage IIIPhase 1NCT07397026

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

A Phase 1 study testing Resveratrol loaded gel in people with Periodontitis Stage III, run by Hagar Ahmed Ali Mohammed Elzain at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis Stage III
What is being tested?
Resveratrol loaded gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteEgypt
Study dates
9 Aug 2025to 1 Apr 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of dentistry , Mansoura university

    Al Mansurah, DK, 35516

Other trials in Egypt

About this study

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.

Read the 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.

Being tested
Resveratrol loaded gel
Keywords
Periodontitis, Resveratrol, Nanoparticles, Cox-2, Scaling, root planing, Gingival crevicular fluid, Superoxide dismutase
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resveratrol loaded gelDrug

    Also called (Resveratrol loaded gel ), Resveratrol Loaded Nanoparticles

    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 .

Study groups in NCT07397026
Study groupRoleWhat they receive
Group 1 (negative control group): includes 12 periodontally healthy subjectsNo interventionHealthy 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 planingSham comparatorPatients 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.
Receives: Drug: Resveratrol loaded gel
Group 3 (placebo group): includes 12 patients will be treated with Resveratrol unloaded gelPlacebo comparatorPatients 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 .
Receives: Drug: Resveratrol loaded gel
Group 4 (Resveratrol Loaded Nanoparticles):12 patients will be injected with Resveratrol loaded gelOtherPatients 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 .
Receives: Drug: Resveratrol loaded gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (1)
  1. laboratory evaluation of Cox-2 & SOD in GCF

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start9 Aug 2025
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397026
Sponsor's protocol ID
M0102025OM
Status last verified
Feb 2026
First submitted
21 Dec 2025
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kornman KS. Controlled-Release Local Delivery Antimicrobials in Periodontics: Prospects for the Future. J Periodontol. 1993 Aug;64 Suppl 8S:782-791. doi: 10.1902/jop.1993.64.8s.782.

    PubMed 29539751
  • Goodson JM, Haffajee A, Socransky SS. Periodontal therapy by local delivery of tetracycline. J Clin Periodontol. 1979 Apr;6(2):83-92. doi: 10.1111/j.1600-051x.1979.tb02186.x.

    PubMed 379050
  • Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16.

    PubMed 12010523
  • Page RC, Kornman KS. The pathogenesis of human periodontitis: an introduction. Periodontol 2000. 1997 Jun;14:9-11. doi: 10.1111/j.1600-0757.1997.tb00189.x. No abstract available.

    PubMed 9567963
  • Graves DT, Cochran D. The contribution of interleukin-1 and tumor necrosis factor to periodontal tissue destruction. J Periodontol. 2003 Mar;74(3):391-401. doi: 10.1902/jop.2003.74.3.391.

    PubMed 12710761
  • Darveau RP. Periodontitis: a polymicrobial disruption of host homeostasis. Nat Rev Microbiol. 2010 Jul;8(7):481-90. doi: 10.1038/nrmicro2337.

    PubMed 20514045
  • Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.

    PubMed 25534621
  • Socransky SS, Haffajee AD. Dental biofilms: difficult therapeutic targets. Periodontol 2000. 2002;28:12-55. doi: 10.1034/j.1600-0757.2002.280102.x. No abstract available.

    PubMed 12013340
  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Resveratrol loaded gel in people with Periodontitis Stage III, run by Hagar Ahmed Ali Mohammed Elzain at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical attachment level (CAL) as Clinical periodontal parameter (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397026, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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