Stage II Grade B PeriodontitisNCT07801417
Clinical & Biochemical Evaluation of Antioxidant Vs. Chlorhexidine as an Adjunctive to Non-Surgical Treatment of Stage II-grade B Periodontitis
A study testing Perioscience Gel, High Cure Chlorhexidine Gel and High Cure Chlorhexidine Gel + Perioscience Gel in people with Stage II Grade B Periodontitis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to evaluate and compare the clinical and biochemical effects of an antioxidant agent and chlorhexidine when used as adjuncts to non-surgical periodontal therapy in patients with Stage II Grade B periodontitis. Read more about this study
- Who is it for?
- Ages 25 to 40 months
- Conditions the study is for
- Stage II Grade B Periodontitis
- What is being tested?
- Perioscience Gel, High Cure Chlorhexidine Gel and High Cure Chlorhexidine Gel + Perioscience Gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Jul 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 40 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1- Patients diagnosed as having stage II periodontitis (22) 2- Clinical attachment loss ranged from 3-4mm 3- Radiographic bone loss ranged from 15% to 30%, mostly horizontal 4- Male or female aged from 25 - 40 years old
Who cannot join
- 1- Smoking patient 2- Pregnancy and breastfeeding patients. 3- Patients with systemic conditions which could affect the outcome of periodontal therapy.
- 4- Previous periodontal therapy in last 6 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical & Biochemical Evaluation of Antioxidant Vs. Chlorhexidine as an Adjunctive to Non-Surgical Treatment of Stage II-grade B Periodontitis.
This randomized clinical trial aims to evaluate and compare the clinical and biochemical effects of an antioxidant agent and chlorhexidine when used as adjuncts to non-surgical periodontal therapy in patients with Stage II Grade B periodontitis. Eligible participants will receive scaling and root planing (SRP) and will be randomly assigned to either the antioxidant or chlorhexidine treatment group. Clinical periodontal parameters, including plaque index, gingival index, probing depth, and clinical attachment level, will be assessed at baseline and follow-up visits. Biochemical analysis of inflammatory markers, including tumor necrosis factor-alpha (TNF-α) and interleukin-1 (IL-1), will be performed to evaluate the inflammatory response to treatment. The study aims to determine whether antioxidant therapy provides comparable or superior benefits to chlorhexidine as an adjunct to non-surgical periodontal treatment.
- Conditions
- Stage II Grade B Periodontitis
- Being tested
- Perioscience Gel, High Cure Chlorhexidine Gel, High Cure Chlorhexidine Gel + Perioscience Gel, Scaling and Root Planing (SRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioscience GelDrug
Local application of Perioscience antioxidant gel into periodontal pockets following scaling and root planing (SRP).
High Cure Chlorhexidine GelDrug
Local application of High Cure chlorhexidine gel into periodontal pockets following scaling and root planing (SRP).
High Cure Chlorhexidine Gel + Perioscience GelDrug
Local application of both High Cure chlorhexidine gel and Perioscience gel into periodontal pockets following scaling and root planing (SRP).
Scaling and Root Planing (SRP)Procedure or surgery
Conventional full-mouth scaling and root planing performed using ultrasonic and hand instruments.
| Study group | Role | What they receive |
|---|---|---|
| Perioscience Gel + SRP | Experimental | Participants receive scaling and root planing (SRP) followed by local application of antioxidant gel. Receives: Drug: Perioscience Gel |
| Chlorhexidine Gel + SRP | Experimental | Participants receive scaling and root planing (SRP) followed by local application of chlorhexidine gel. Receives: Drug: High Cure Chlorhexidine Gel |
| Antioxidant Gel + Chlorhexidine Gel + SRP | Experimental | Participants receive scaling and root planing (SRP) followed by local application of both antioxidant gel and chlorhexidine gel. Receives: Drug: High Cure Chlorhexidine Gel + Perioscience Gel |
| SRP Alone | Active comparator | Participants receive scaling and root planing (SRP) only, without adjunctive gel application. Receives: Procedure: Scaling and Root Planing (SRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Crevicular Fluid (GCF) Level of Interleukin-1 (IL-1)
Changes in the concentration of Interleukin-1 (IL-1) in gingival crevicular fluid (GCF) will be assessed before and after the intervention using an enzyme-linked immunosorbent assay (ELISA) with unit of measurement pg/mL .
Measured: Baseline to 6 months after treatment
Gingival Crevicular Fluid (GCF) Level of Tumor Necrosis Factor-alpha (TNF-α)
Changes in the concentration of Tumor Necrosis Factor-alpha (TNF-α) in gingival crevicular fluid (GCF) will be assessed before and after the intervention using an enzyme-linked immunosorbent assay (ELISA) with unit of measurement pg/mL .
Measured: Baseline and 6 months after treatment
Secondary outcomes (4)
Probing Depth (PD)
Probing depth will be measured in millimeters using a periodontal probe at the selected periodontal sites.
Measured: Baseline to 6 months after treatment.
Gingival Index (GI)
Gingival status will be assessed using the Gingival Index, scored (0 - 3) at the selected periodontal sites.
Measured: baseline to 6 months after treatment
Clinical Attachment Level (CAL)
Clinical attachment level will be measured in millimeters using a periodontal probe at the selected periodontal sites.
Measured: baseline to 6 month after treatment
Plaque Index (PI)
Dental plaque accumulation will be assessed using the Plaque Index, scored (0 - 3) at the selected periodontal sites.
Measured: baseline to 6 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Grade B PeriodontitisStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Yassen Yousef Radwan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801417
- Sponsor's protocol ID
- OMPDR-105-1w
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical & Biochemical Evaluation of Antioxidant Vs. Chlorhexidine as an Adjunctive to Non-Surgical Treatment of Stage II-grade B Periodontitis.
- ClinicalTrials.gov ID
- NCT07801417
- Acronym / sponsor ID
- OMPDR-105-1w
- Conditions
- Stage II Grade B Periodontitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Sep 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.
This randomized clinical trial aims to evaluate and compare the clinical and biochemical effects of an antioxidant agent and chlorhexidine when used as adjuncts to non-surgical periodontal therapy in patients with Stage II Grade B periodontitis. Eligible participants will receive scaling and root planing (SRP) and will be randomly assigned to either the antioxidant or chlorhexidine treatment group. Clinical periodontal parameters, including plaque index, gingival index, probing depth, and clinical attachment level, will be assessed at baseline and follow-up visits. Biochemical analysis of inflammatory markers, including tumor necrosis factor-alpha (TNF-α) and interleukin-1 (IL-1), will be performed to evaluate the inflammatory response to treatment. The study aims to determine whether antioxidant therapy provides comparable or superior benefits to chlorhexidine as an adjunct to non-surgical periodontal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Perioscience Gel + SRP | Experimental | Drug: Perioscience GelParticipants receive scaling and root planing (SRP) followed by local application of antioxidant gel. |
| Chlorhexidine Gel + SRP | Experimental | Drug: High Cure Chlorhexidine GelParticipants receive scaling and root planing (SRP) followed by local application of chlorhexidine gel. |
| Antioxidant Gel + Chlorhexidine Gel + SRP | Experimental | Drug: High Cure Chlorhexidine Gel + Perioscience GelParticipants receive scaling and root planing (SRP) followed by local application of both antioxidant gel and chlorhexidine gel. |
| SRP Alone | Active comparator | Procedure: Scaling and Root Planing (SRP)Participants receive scaling and root planing (SRP) only, without adjunctive gel application. |
Who may qualify
- Ages
- 25 to 40 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1- Patients diagnosed as having stage II periodontitis (22) 2- Clinical attachment loss ranged from 3-4mm 3- Radiographic bone loss ranged from 15% to 30%, mostly horizontal 4- Male or female aged from 25 - 40 years old
Key exclusion criteria (2 listed)
- 1- Smoking patient 2- Pregnancy and breastfeeding patients. 3- Patients with systemic conditions which could affect the outcome of periodontal therapy.
- 4- Previous periodontal therapy in last 6 month.
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 |
|---|---|---|
| Perioscience GelLocal application of Perioscience antioxidant gel into periodontal pockets following scaling and root planing (SRP). | Drug | Perioscience Gel + SRP |
| High Cure Chlorhexidine GelLocal application of High Cure chlorhexidine gel into periodontal pockets following scaling and root planing (SRP). | Drug | Chlorhexidine Gel + SRP |
| High Cure Chlorhexidine Gel + Perioscience GelLocal application of both High Cure chlorhexidine gel and Perioscience gel into periodontal pockets following scaling and root planing (SRP). | Drug | Antioxidant Gel + Chlorhexidine Gel + SRP |
| Scaling and Root Planing (SRP)Conventional full-mouth scaling and root planing performed using ultrasonic and hand instruments. | Procedure or surgery | SRP Alone |
Primary outcome
Gingival Crevicular Fluid (GCF) Level of Interleukin-1 (IL-1)
Time frame: Baseline to 6 months after treatment
Changes in the concentration of Interleukin-1 (IL-1) in gingival crevicular fluid (GCF) will be assessed before and after the intervention using an enzyme-linked immunosorbent assay (ELISA) with unit of measurement pg/mL .
Gingival Crevicular Fluid (GCF) Level of Tumor Necrosis Factor-alpha (TNF-α)
Time frame: Baseline and 6 months after treatment
Changes in the concentration of Tumor Necrosis Factor-alpha (TNF-α) in gingival crevicular fluid (GCF) will be assessed before and after the intervention using an enzyme-linked immunosorbent assay (ELISA) with unit of measurement pg/mL .
4 secondary outcomes
Probing Depth (PD)
Time frame: Baseline to 6 months after treatment.
Gingival Index (GI)
Time frame: baseline to 6 months after treatment
Clinical Attachment Level (CAL)
Time frame: baseline to 6 month after treatment
Plaque Index (PI)
Time frame: baseline to 6 month 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 3 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioscience Gel, High Cure Chlorhexidine Gel and High Cure Chlorhexidine Gel + Perioscience Gel in people with Stage II Grade B Periodontitis, run by Al-Azhar 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Crevicular Fluid (GCF) Level of Interleukin-1 (IL-1) (time frame: Baseline to 6 months after treatment). The study lists 2 primary outcomes in all. 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 3 Sep 2026.