Advanced PeriodontitisPhase 2/3NCT06675578
Treatment of Periodontitis by Tulsi Gel
A Phase 2/3 study testing Tulsi gel and Chlorhexidine gel in people with Advanced Periodontitis and Stage III Periodontitis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study will be carried out to compare between the effect of 4%Tulsi gel and 1%Chlorohexidine gel as locally administered agents in the treatment of advanced periodontitis. Clinical parameters measurements, microbiological and radiographic assessment will be performed at base line, one month and 3 months after the… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Advanced Periodontitis, Stage III Periodontitis, Stage IV Periodontitis
- What is being tested?
- Tulsi gel and Chlorhexidine gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2025to Nov 2025
- Phase
- Phase 2/3
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients included in this study will be having advancedI Periodontitis
- Aging from 30 to 50 years old
- Free from any local or systemic risk factors that may affect the results of the study.
Who cannot join
- Long-term therapy with medications within a month prior to enrollment that could affect periodontal status or healing.
- Pregnant woman and lactating mothers.
- Patients with previous periodontal treatment including scaling and root planning and periodontal surgery in the last 3 and 6 months, respectively.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Non Surgical Treatment Using Tulsi Gel Versus Chlorhexidine Gel as Adjunctive in Treatment of Advanced Periodontitis ( Stage III and Stage IV )
This study will be carried out to compare between the effect of 4%Tulsi gel and 1%Chlorohexidine gel as locally administered agents in the treatment of advanced periodontitis. Clinical parameters measurements, microbiological and radiographic assessment will be performed at base line, one month and 3 months after the intervention.
- Being tested
- Tulsi gel, Chlorhexidine gel
- Keywords
- periodontitis, clinical attachment loss, advanced periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tulsi gelDrug
Also called Basil gel
After scaling and root debridement, 4% of Tulsi gel will be injected in to the sulcus until it over flooded, at base line, then after one month.
Chlorhexidine gelDrug
Also called Corsodyl 1% w/w dental gel
After scaling and root debridement, 1% of Chlorhexidine gel will be injected in to the sulcus until it over flooded, at base line, then after one month.
| Study group | Role | What they receive |
|---|---|---|
| Tulsi Gel group | Active comparator | Ocimum sanctum Receives: Drug: Tulsi gel |
| Chlorhexidine Gel group | Active comparator | Chlorhexidine Receives: Drug: Chlorhexidine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical parameters
Improvement of the clinical attachment loss in millimeters.
Measured: 3 months after end of treatment
Clinical parameters
Improvement of gingival index.
Measured: 3 months after end of treatment
Clinical parameters
Improvement of probing depth in millimeters.
Measured: 3 months after end of treatment
Secondary outcomes (3)
Microbiological assessment
Counting microbial colony of Porphyromonas gingivalis
Measured: 3 months after end of treatment
Microbiological assessment
Counting microbial colony of Fusobacterium nucleatum
Measured: 3 months after end of treatment
Microbiological assessment
Counting microbial colony of Tannerella forsythia
Measured: 3 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study startJul 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Gamal Elsayed Mohamed Saleh, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675578
- Sponsor's protocol ID
- P-ME-24-12
- Status last verified
- Jun 2025
- First submitted
- 4 Nov 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Surgical Treatment Using Tulsi Gel Versus Chlorhexidine Gel as Adjunctive in Treatment of Advanced Periodontitis ( Stage III and Stage IV )
- ClinicalTrials.gov ID
- NCT06675578
- Acronym / sponsor ID
- P-ME-24-12
- Keywords
- periodontitis, clinical attachment loss, advanced periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 5 Nov 2024 (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 study will be carried out to compare between the effect of 4%Tulsi gel and 1%Chlorohexidine gel as locally administered agents in the treatment of advanced periodontitis. Clinical parameters measurements, microbiological and radiographic assessment will be performed at base line, one month and 3 months after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tulsi Gel group | Active comparator | Drug: Tulsi gelOcimum sanctum |
| Chlorhexidine Gel group | Active comparator | Drug: Chlorhexidine gelChlorhexidine |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients included in this study will be having advancedI Periodontitis
- Aging from 30 to 50 years old
- Free from any local or systemic risk factors that may affect the results of the study.
Key exclusion criteria (3 listed)
- Long-term therapy with medications within a month prior to enrollment that could affect periodontal status or healing.
- Pregnant woman and lactating mothers.
- Patients with previous periodontal treatment including scaling and root planning and periodontal surgery in the last 3 and 6 months, respectively.
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 |
|---|---|---|
| Tulsi gelAlso: Basil gelAfter scaling and root debridement, 4% of Tulsi gel will be injected in to the sulcus until it over flooded, at base line, then after one month. | Drug | Tulsi Gel group |
| Chlorhexidine gelAlso: Corsodyl 1% w/w dental gelAfter scaling and root debridement, 1% of Chlorhexidine gel will be injected in to the sulcus until it over flooded, at base line, then after one month. | Drug | Chlorhexidine Gel group |
Primary outcome
Clinical parameters
Time frame: 3 months after end of treatment
Improvement of the clinical attachment loss in millimeters.
Clinical parameters
Time frame: 3 months after end of treatment
Improvement of gingival index.
Clinical parameters
Time frame: 3 months after end of treatment
Improvement of probing depth in millimeters.
3 secondary outcomes
Microbiological assessment
Time frame: 3 months after end of treatment
Microbiological assessment
Time frame: 3 months after end of treatment
Microbiological assessment
Time frame: 3 months after end of 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 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Periodontitis
Active, not recruiting
C-PRF With Minimally Invasive Non-Surgical Periodontal Therapy
Periodontitis, Intrabony Periodontal Defect
Recruiting
HbA1c Screening in Dental Care and Primary Care Referral in Patients With Advanced Periodontitis
Periodontitis, Adult, Prediabetes / Type 2 Diabetes
Enrolling by invitationObservational study
Blood Glucose Screening in Patients With Advanced Periodontits: the Role of Specialist Periodontal Care in Identifying Hyperglycaemia and Supporting Patient Centered Treatment
Periodontitis Stage III, Periodontitis Stage IV
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.
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 Phase 2/3 study testing Tulsi gel and Chlorhexidine gel in people with Advanced Periodontitis and Stage III 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Jul 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical parameters (time frame: 3 months after end of treatment). The study lists 3 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 1 Jul 2025.