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

NCT07636993 | Completed Early Phase 1 DMC

• 1 other identifier: M04020250M
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Periodontitis; Periodontal Disease; Periodontitis Stage II

Outcome Measures

Primary Outcomes (1)

• assess the clinical effectiveness of the locally delivered ozonated sunflower seed oil as an adjunctive therapy to mechanical debridement in stage II grade B periodontitis

  1\) Plaque Index: deposits were recorded the level of oral hygiene.The percentage of all tooth surfaces that showed the presence of plaque was determined by recording the full-mouth plaque score dichotomously (presence/absence of plaque) on six different points per tooth.The frequency of positive surfaces was given in percentages relative to the total number of tested surfaces. 2) Gingival index: 0 = Normal gingiva.1=Slight inflammation.2 = Moderate glazing. 3 = Severe. 3) Probing pocket depth:For each group, the PPD was measured from the base of the pocket on the whole mouth to the free gingival margin.4) Clinical attachment level:It is the space between the base of the periodontal pocket and CEJ. Six locations were used to measure the clinical attachment loss: three on the facial surface and three on the lingual or palatal surface.5) Bleeding on probing:take the percentage from all teeth that appear BOP

  3 month

Secondary Outcomes (1)

• assess the impact of the locally delivered ozonated sunflower seed oil as an adjunctive therapy to mechanical debridement on the GCF level of TNF-α in stage II periodontitis

  3 months

Study Arms (4)

positive control group

OTHER

control recived mechanical debridment only

Other: Mechanical debridement .

negative control

NO INTERVENTION

healthy

study group A

EXPERIMENTAL

sunflower seed oil gel for each pocket

Drug: sun flower

study group B

EXPERIMENTAL

Ozonated Sunflower Oil

Drug: ozonated sun flower

Interventions

Mechanical debridement . OTHER

mechanical debridment

positive control group

sun flower DRUG

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

study group A

ozonated sun flower DRUG

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

study group B

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Stage II Periodontitis grade B periodontitis (horizontal bone loss with maximum probing depth ≤ 5 mm and with 3-4 mm clinical attachment loss).
• Minimum of 20 remaining teeth.
• Age range (25 - 50) years.
• Good compliance with the plaque control instructions following initial therapy.
• Availability for follow up and maintenance program.

You may not qualify if:

• Systemic diseases / drugs which could influence the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).
• Receiving periodontal therapy in past 6 month.
• Pregnant and lactating females.
• Vulnerable groups of patients (e.g handicapped patients and decisionally impaired individuals).
• Smoking.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, faculty of dentistry

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Hashem Alshareef, Bachelors degree

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor 's degree, Faculty of Dentistry, Umm Alqura University, Saudi Arabia

Model Details: this is a retrospective interventional study

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 9, 2026
• Study Start: March 7, 2025
• Primary Completion: March 25, 2026
• Study Completion: April 30, 2026
• Last Updated: June 9, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)