Treatment of Periodontitis by Tulsi Gel

June 27, 2025 updated by: Alaa Gamal Elsayed Mohamed Saleh, Al-Azhar University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry, Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tulsi Gel group
Ocimum sanctum
Drug: Tulsi 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.
Other Names:
  • Basil gel
Active Comparator: Chlorhexidine Gel group
Chlorhexidine
Drug: Chlorhexidine 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.
Other Names:
  • Corsodyl 1% w/w dental gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical parameters
Time Frame: 3 months after end of treatment
Improvement of the clinical attachment loss in millimeters.
3 months after end of treatment
Clinical parameters
Time Frame: 3 months after end of treatment
Improvement of gingival index.
3 months after end of treatment
Clinical parameters
Time Frame: 3 months after end of treatment
Improvement of probing depth in millimeters.
3 months after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological assessment
Time Frame: 3 months after end of treatment
Counting microbial colony of Porphyromonas gingivalis
3 months after end of treatment
Microbiological assessment
Time Frame: 3 months after end of treatment
Counting microbial colony of Fusobacterium nucleatum
3 months after end of treatment
Microbiological assessment
Time Frame: 3 months after end of treatment
Counting microbial colony of Tannerella forsythia
3 months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-ME-24-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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