NCT06675578

Brief 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 intervention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

November 4, 2024

Last Update Submit

June 27, 2025

Conditions

Keywords

periodontitisclinical attachment lossadvanced periodontitis

Outcome Measures

Primary Outcomes (3)

  • Clinical parameters

    Improvement of the clinical attachment loss in millimeters.

    3 months after end of treatment

  • Clinical parameters

    Improvement of gingival index.

    3 months after end of treatment

  • Clinical parameters

    Improvement of probing depth in millimeters.

    3 months after end of treatment

Secondary Outcomes (3)

  • Microbiological assessment

    3 months after end of treatment

  • Microbiological assessment

    3 months after end of treatment

  • Microbiological assessment

    3 months after end of treatment

Study Arms (2)

Tulsi Gel group

ACTIVE COMPARATOR

Ocimum sanctum

Drug: Tulsi gel

Chlorhexidine Gel group

ACTIVE COMPARATOR

Chlorhexidine

Drug: Chlorhexidine gel

Interventions

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.

Also known as: Basil gel
Tulsi Gel group

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.

Also known as: Corsodyl 1% w/w dental gel
Chlorhexidine Gel group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Al-Azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 5, 2024

Study Start

July 1, 2025

Primary Completion

August 1, 2025

Study Completion

November 1, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations