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Assessment of Ozonated Sunflower Seed Oil Gel as an Adjunctive Therapy to Mechanical Debridement in the Treatment of Stage II Grade B Periodontitis

NCT07636993 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-09

No results posted yet for this study

Summary

I) Patients:

The present study will be carried on periodontitis patients. The patients will be informed about the treatment steps. This includes the possible effects or risks, and other treatment options according to the rules of the Ethical Committee of Faculty of dentistry, Mansoura University.

Groups:

Group I (negative control): 15 periodontally healthy subjects. Group II (positive control): 15 patients will be treated with mechanical debridement only.

Group III (study group A): 15 patients will be treated with mechanical debridement followed by delivery of sunflower seed oil gel for each pocket. (J MAC BOTANICALS, organic cold pressed helianthus annuus sunflower seed oil, Waterglider LLC. Spokane Valley, WA 99216, USA).

Group IV (study group B): 15 patients will be treated with mechanical debridement followed by delivery of ozonated sunflower seed oil gel for each pocket.( PurO3, Ozonated Sunflower Oil combines organic sunflower oil and ozone, giving you an oxygen-rich, soothing gel with high amounts of ozone, 1220 S Happy Hollow Rd Fayetteville, AR 72701, USA).

Periodontal evaluation will be performed for all patients at baseline and after three months including the following parameters:

* Plaque index (PI).(15)
* Gingival index.(16)
* Probing pocket depth (PPD).(17)
* Clinical attachment level (CAL).(18) B) Gingival crevicular fluid sampling. C) Local drug delivery Adequate amount of prepared ozonated sunflower and sunflower oil gel will be delivered into the selected periodontal pockets.

B) Immunological analysis of TNF-α in GCF

Conditions

Interventions

OTHER

Mechanical debridement .

mechanical debridment

DRUG

sun flower

patients will be treated with mechanical debridement followed by delivery of sunflower seed oil gel for each pocket

DRUG

ozonated sun flower

patients will be treated with mechanical debridement followed by delivery of ozonated sunflower seed oil gel for each pocket

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ahmed Hashem Alshareef, Bachelors degree · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-07
Primary Completion
2026-03-25
Completion
2026-04-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07636993 on ClinicalTrials.gov