Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis

April 6, 2021 updated by: sudhir rama varma, Ajman University

Role of Moringa Dentifirice in the Management of Plaque Induced Gingivitis. A Clinical Crossover Study

The clinical cross over study involves the use of two herbal based dentifirices moringa and miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are provided with details regarding the research format and consent taken.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The clinical cross over study involves use of miswak and moringa dentifrices. The patients selected are 30 in no and are selected based on having gingival inflammation due to plaque accumulation. All other cases related to gingival inflammation along with patients with underlying systemic disease are excluded from the study.

At baseline, plaque and gingival scores are recorded, followed by giving one of the dentifrice to the patient for brushing. The patients are asked to brush twice a day and asked to report after 72 hrs, following which another recording of plaque and gingival scores are recorded.

The patients are then asked to use their own tooth paste for a period of 2 weeks as a wash out period and recalled after this 2 week interval.

The patients are then given the second dentifrice and asked to brush for 72 hrs and then asked to report again for a plaque and gingival score evaluation.

Study Type

Interventional

Enrollment (Actual)

30

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

  • India
      • Mangaluru, India
        • AB shetty Institute of dental sciences

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects having only plaque induced gingival inflammation

Exclusion Criteria:

  • Subjects having gingival inflammation related to underling systemic diseases
  • Subjects taking medications
  • Gingival inflammation related to other causes

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: moringa
First phase of subjects were given dentifrice for brushing
Other: dentifrice
use of dentifrices for brushing
Active Comparator: miswak
second phase of subjects were given dentifrice for brushing
Other: dentifrice
use of dentifrices for brushing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plaque scores
Time Frame: 72 hours
plaque score recorded using calibrated periodontal probes
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival inflammation scores
Time Frame: 72 hours
Gingival bleeding scores recorded using caliberated periodontal probes
72 hours

Collaborators and Investigators

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

Sponsor

Ajman University

Collaborators

A B Shetty Memorial Institute of Dental Science

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)

January 20, 2021

Primary Completion (Actual)

March 20, 2021

Study Completion (Actual)

March 28, 2021

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-F-19-03-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results of this study will be shared to other researchers

IPD Sharing Time Frame

Data can be accessible in a months time. The data will have unrestricted time frame

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

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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