Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara A Agha, B.D.S
- Phone Number: 00201025536848
- Email: Ahmedagha55aa@gmail.com
Study Locations
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-
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Cairo, Egypt, 12511
- Recruiting
- October 6 University
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Sub-Investigator:
- Osama S El-Shall, MD
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Contact:
- Sara A Agha, B.Sc
- Phone Number: 00201025536848
- Email: Ahmedagha55aa@gmail.com
-
Sub-Investigator:
- Amany A Al-Araby, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group I (control - standard of care control)
Participants will receive conventional scaling and root planing only. |
Participants will receive conventional scaling and root planing only. |
|
Experimental: Group II (experimental)
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
|
Experimental: Group III (experimental)
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.. |
6 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in gingival crevicular fluid Interleukin-1 level
Time Frame: 6 months after treatment
|
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.. |
6 months after treatment
|
|
Change in Plaque Index
Time Frame: 6 months after treatment
|
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. |
6 months after treatment
|
|
Change in Gingival Index
Time Frame: 6 months after treatment
|
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. |
6 months after treatment
|
|
Change in Periodontal Probing Depth
Time Frame: 6 months after treatment
|
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. |
6 months after treatment
|
|
Change in Clinical Attachment Level
Time Frame: 6 months after treatment
|
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. |
6 months after treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- (4) 27/4/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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