Ozone GelNCT07923708
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
A study testing Conventional scaling and root planing, Conventional scaling and root planing in addition to chlorhexidine gel and Conventional scaling and root planing in addition to ozone gel in people with Ozone Gel and Chlorohexidine Gel, run by October 6 University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate and compare the clinical and biochemical outcomes of Ozoral® and High Cure® (chlorhexidine gel) as adjuncts to non-surgical periodontal therapy in smoker patients with Stage II Grade B periodontitis, using non-smoker patients with the same diagnosis as a comparative control… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Ozone Gel, Chlorohexidine Gel, Non-Surgical Treatment
- What is being tested?
- Conventional scaling and root planing, Conventional scaling and root planing in addition to chlorhexidine gel and Conventional scaling and root planing in addition to ozone gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Jun 2027
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged 25-45 years
- Diagnosed with Stage II Grade B periodontitis
- Clinical attachment loss of 3-4 mm
- Radiographic bone loss confined to the coronal third of the root
- Either smokers or non-smokers
Who cannot join
- Systemic diseases affecting periodontal health
- Pregnancy or lactating female
- Periodontal therapy within the last 6 months
- Use of antibiotics or anti-inflammatory medication during the last
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University
Cairo, 12511
Sara A Agha, B.Sc, 00201025536848, Ahmedagha55aa@gmail.com
Osama S El-Shall, MD
About this study
Official title: Clinical and Biochemical Evaluation of Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
The aim of the present study is to evaluate and compare the clinical and biochemical outcomes of Ozoral® and High Cure® (chlorhexidine gel) as adjuncts to non-surgical periodontal therapy in smoker patients with Stage II Grade B periodontitis, using non-smoker patients with the same diagnosis as a comparative control group.
Read the detailed description
Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding a tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament.
Chlorhexidine (CHX) has been widely used in dentistry as an antiplaque and antimicrobial agent due to its broad-spectrum activity against Gram-positive and Gram-negative bacteria, fungi, and some viruses. The antimicrobial action of chlorhexidine is mainly attributed to its ability to alter bacterial cell membrane permeability, resulting in leakage of intracellular components.
Ozone (O₃) is a highly reactive oxidizing agent that has gained increasing attention in medical and dental applications because of its potent antimicrobial, anti-inflammatory, and wound-healing properties. Ozone exerts its antimicrobial effect through oxidative damage to microbial cell walls and intracellular components, leading to rapid microbial inactivation.
- Being tested
- Conventional scaling and root planing, Conventional scaling and root planing in addition to chlorhexidine gel, Conventional scaling and root planing in addition to ozone gel
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional scaling and root planingProcedure or surgery
Participants will receive conventional scaling and root planing only.
Conventional scaling and root planing in addition to chlorhexidine gelProcedure or surgery
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery.
Conventional scaling and root planing in addition to ozone gelProcedure or surgery
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery.
| Study group | Role | What they receive |
|---|---|---|
| Group I (control - standard of care control) | Active comparator | Participants will receive conventional scaling and root planing only. Receives: Procedure: Conventional scaling and root planing |
| Group II (experimental) | Experimental | Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. Receives: Procedure: Conventional scaling and root planing in addition to chlorhexidine gel |
| Group III (experimental) | Experimental | Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. Receives: Procedure: Conventional scaling and root planing in addition to ozone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival crevicular fluid tumor necrosis factor-alpha level
Change from baseline in gingival crevicular fluid tumor necrosis factor-alpha (TNF-α) level will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment..
Measured: 6 months after treatment
Secondary outcomes (5)
Change in gingival crevicular fluid Interleukin-1 level
Change from baseline in gingival crevicular fluid Interleukin-1(IL-1) evel will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment..
Measured: 6 months after treatment
Change in Plaque Index
Change from baseline in Plaque Index, scored from 0 (no plaque) to 3 (abundant plaque accumulation). Lower scores indicate better oral hygiene. Changes will be compared among the three treatment groups.
Measured: 6 months after treatment
Change in Gingival Index
Change from baseline in Gingival Index, scored from 0 (normal gingiva) to 3 (severe inflammation with a tendency toward spontaneous bleeding). Lower scores indicate less gingival inflammation. Changes will be compared among the three treatment groups.
Measured: 6 months after treatment
Change in Periodontal Probing Depth
Change from baseline in periodontal probing depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a periodontal probe. A reduction indicates improvement. Changes will be compared among the three treatment groups.
Measured: 6 months after treatment
Change in Clinical Attachment Level
Change from baseline in clinical attachment level will be measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a periodontal probe. A reduction in this distance indicates clinical attachment gain. Changes will be compared among the three treatment groups.
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Sep 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ozone GelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Hamed Agha, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923708
- Sponsor's protocol ID
- (4) 27/4/2026
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
- ClinicalTrials.gov ID
- NCT07923708
- Acronym / sponsor ID
- (4) 27/4/2026
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate and compare the clinical and biochemical outcomes of Ozoral® and High Cure® (chlorhexidine gel) as adjuncts to non-surgical periodontal therapy in smoker patients with Stage II Grade B periodontitis, using non-smoker patients with the same diagnosis as a comparative control group.
Detailed description
Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding a tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament.
Chlorhexidine (CHX) has been widely used in dentistry as an antiplaque and antimicrobial agent due to its broad-spectrum activity against Gram-positive and Gram-negative bacteria, fungi, and some viruses. The antimicrobial action of chlorhexidine is mainly attributed to its ability to alter bacterial cell membrane permeability, resulting in leakage of intracellular components.
Ozone (O₃) is a highly reactive oxidizing agent that has gained increasing attention in medical and dental applications because of its potent antimicrobial, anti-inflammatory, and wound-healing properties. Ozone exerts its antimicrobial effect through oxidative damage to microbial cell walls and intracellular components, leading to rapid microbial inactivation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (control - standard of care control) | Active comparator | Procedure: Conventional scaling and root planingParticipants will receive conventional scaling and root planing only. |
| Group II (experimental) | Experimental | Procedure: Conventional scaling and root planing in addition to chlorhexidine gelParticipants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
| Group III (experimental) | Experimental | Procedure: Conventional scaling and root planing in addition to ozone gelParticipants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female patients aged 25-45 years
- Diagnosed with Stage II Grade B periodontitis
- Clinical attachment loss of 3-4 mm
- Radiographic bone loss confined to the coronal third of the root
- Either smokers or non-smokers
Key exclusion criteria (4 listed)
- Systemic diseases affecting periodontal health
- Pregnancy or lactating female
- Periodontal therapy within the last 6 months
- Use of antibiotics or anti-inflammatory medication during the last
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional scaling and root planingParticipants will receive conventional scaling and root planing only. | Procedure or surgery | Group I (control - standard of care control) |
| Conventional scaling and root planing in addition to chlorhexidine gelParticipants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. | Procedure or surgery | Group II (experimental) |
| Conventional scaling and root planing in addition to ozone gelParticipants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. | Procedure or surgery | Group III (experimental) |
Primary outcome
Change in gingival crevicular fluid tumor necrosis factor-alpha level
Time frame: 6 months after treatment
Change from baseline in gingival crevicular fluid tumor necrosis factor-alpha (TNF-α) level will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment..
5 secondary outcomes
Change in gingival crevicular fluid Interleukin-1 level
Time frame: 6 months after treatment
Change in Plaque Index
Time frame: 6 months after treatment
Change in Gingival Index
Time frame: 6 months after treatment
Change in Periodontal Probing Depth
Time frame: 6 months after treatment
Change in Clinical Attachment Level
Time frame: 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Ozone Gel
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Ozone Oil-based Gel and CHX Gel After Lower Third Molar Removal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional scaling and root planing, Conventional scaling and root planing in addition to chlorhexidine gel and Conventional scaling and root planing in addition to ozone gel in people with Ozone Gel and Chlorohexidine Gel, run by October 6 University 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 4 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: looking for participants now, as of the sponsor's last update on 6 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Sara A Agha, B.D.S (00201025536848, Ahmedagha55aa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gingival crevicular fluid tumor necrosis factor-alpha level (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.