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

Assessment of Ozonated Sunflower Seed Oil Gel as an Adjunctive Therapy to Mechanical Debridement in the Treatment of Stage II Grade B Periodontitis (Clinical and Laboratory Study)

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

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Disease; Periodontitis Stage II
• Intervention / Treatment: Other: Mechanical debridement .; Drug: sun flower; Drug: ozonated sun flower

Detailed Description

I) Patients:

The present study will be carried on periodontitis patients. The patient will be selected from Out Patient Clinic, Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dentistry, Mansoura University. 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. The patients must be legally competent to provide written consent before performing any required steps.

A)Inclusion Criteria

1. 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).
2. Minimum of 20 remaining teeth.
3. Age range (25 - 50) years.
4. Good compliance with the plaque control instructions following initial therapy.
5. Availability for follow up and maintenance program. B) Exclusion Criteria

1. Systemic diseases / drugs which could influence the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).

2. Receiving periodontal therapy in past 6 month. 3. Pregnant and lactating females. 4. Vulnerable groups of patients (e.g handicapped patients and decisionally impaired individuals).

5. Smoking.

D) 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).

II) Clinical Procedures:

• Medical and dental histories will be taken from patients.
• Mechanical debridement will be performed using suitable ultrasonic and hand instruments for positive control and study groups.

A) Periodontal assessment:

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. The GCF samples will be collected from all subjects at baseline and three months after treatment.(19)

C) Local drug delivery Adequate amount of prepared ozonated sunflower and sunflower oil gel will be delivered into the selected periodontal pockets.

III) Laboratory procedures

A) Pharmaceutics Section: Formulation development:

1. Sunflower oil and derevatives:

   The study will involve using sunflower oil as pure form and/or ozonated using controlled conditions. The oils will be used in preparation of gel formulation for applications in the mouth cavity using different formulation techniques.

2. Development of Formulations:

Based on the oil formulation, various gels will be developed with a focus on creating formulations suitable for clinical application.

• Different gel bases will be evaluated to optimize their physicochemical characteristics.
• Physicochemical Parameters of the gel formulations will be assessed to ensure the desired properties.
• The developed gels will undergo in-vitro testing under different conditions.
• Once optimized, the selected gel formulation(s) will be prepared for testing in clinical trials.

B) Immunological analysis of TNF-α in GCF

Assessment of crevicular fluid TNF-α will be performed using enzyme-linked immunosorbent assay technique

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • Mansoura University, faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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).
2. Minimum of 20 remaining teeth.
3. Age range (25 - 50) years.
4. Good compliance with the plaque control instructions following initial therapy.
5. Availability for follow up and maintenance program.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: positive control group; control recived mechanical debridment only	Other: Mechanical debridement .; mechanical debridment
No Intervention: negative control; healthy
Experimental: study group A; sunflower seed oil gel for each pocket	Drug: sun flower; patients will be treated with mechanical debridement followed by delivery of sunflower seed oil gel for each pocket
Experimental: study group B; Ozonated Sunflower Oil	Drug: ozonated sun flower; patients will be treated with mechanical debridement followed by delivery of ozonated sunflower seed oil gel for each pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	GCF sample will be assessed for TNF-α. TNF-α. is an inflammatory mediator. Assessment of gingival crevicular fluid(GCF) TNF-α will be performed using enzyme-linked immunosorbent assay technique.	3 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ahmed Hashem Alshareef, Bachelors degree, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Actual): March 25, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: M04020250M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No