Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity

February 24, 2024 updated by: Afsheen Mansoor, Pakistan Institute of Medical Sciences

Clinical Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Hypersensitivity of Teeth

Type of study: Single-blinded clinical trial to evaluate the effectiveness of Azadirachta indica based Herbal mouthwash to treat the tooth sensitivity in patients.

Participants aged 20 years and above having Gingival Index score 3 will be included in the study. Their tooth sensitivity will be checked initially and then they will be given Herbal based mouthwash for 3 months. Again, their tooth sensitivity shall be checked after 3 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study Herbal based mouthwash will be evaluated for eliminating the tooth sensitivity in the participants having Gingival Index score 3 with VAS scores for sensitivity ranging between 30-80 . Consecutive non-random sampling technique will be used in this study where Participants included will be assessed for tooth sensitivity through Visual Analogue Scale (VAS) initially for base line readings. These participants will be given Azadirachta indica based Herbal mouthwash for three months and then again their tooth sensitivity will be assessed by Visual Analogue Scale (VAS) for final readings. The mean values of VAS scoring both before and after the usage of herbal mouth wash will be compared to investigate the clinical efficacy of this mouthwash in treating the tooth sensitivity.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

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

  • Pakistan
      • Islamabad, Pakistan, 44080
        • Afsheen Mansoor

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with good general health and no allergy
  • Patients who have not used any mouthwash in last 3 month
  • Study teeth shall be free of decay and restoration
  • Study teeth shalll not be mobile
  • Study teeth shall have the Gingival Index score 3
  • Participants shall be able to read ,write and willing to give consent.

Exclusion Criteria:

  • Patients with poor general health and allergies
  • Patients who have used any mouthwash in last 3 months
  • Teeth with decay and restorations
  • Teeth with mobility
  • Teeth with Gingival Index score more than 3
  • Participants that wonn't be able to read ,write and willing to give consent.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Group
Participants will be assessed for their tooth sensitivity (VAS scoring) and after giving herbal based mouthwash sensitivity will be assessed after 3 months
Diagnostic test: Herbal based mouthwash
Herbal based mouthwash will be used to treat the tooth sensitivity in participants having VAS score values of tooth sensitivity ranging between 30-80

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toothsensitivity declination with herbal based mouthwash
Time Frame: 3 months
Evaluation of herbal based mouth wash in eliminating the tooth sensitivity ranging between VAS scores 30-80.
3 months

Collaborators and Investigators

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

Sponsor

Pakistan Institute of Medical Sciences

Investigators

  • Principal Investigator: Afsheen Mansoor, PhD, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2023

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Estimated)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOD/ERB/2023/22-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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