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Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis

Primary Purpose

Gingiva; Infection, Plaque, Dental

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

dentifrice

About this trial

This is an interventional prevention trial for Gingiva; Infection focused on measuring miswak, moringa, plaque, gingival bleeding

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

AB shetty Institute of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

moringa

miswak

Arm Description

First phase of subjects were given dentifrice for brushing

second phase of subjects were given dentifrice for brushing

Outcomes

Primary Outcome Measures

plaque scores

plaque score recorded using calibrated periodontal probes

Secondary Outcome Measures

Gingival inflammation scores

Gingival bleeding scores recorded using caliberated periodontal probes

Full Information

NCT ID

NCT04830176

First Posted

April 1, 2021

Last Updated

April 6, 2021

Sponsor

Ajman University

Collaborators

A B Shetty Memorial Institute of Dental Science

1. Study Identification

Unique Protocol Identification Number

NCT04830176

Brief Title

Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

January 20, 2021 (Actual)

Primary Completion Date

March 20, 2021 (Actual)

Study Completion Date

March 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ajman University

Collaborators

A B Shetty Memorial Institute of Dental Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingiva; Infection, Plaque, Dental

Keywords

miswak, moringa, plaque, gingival bleeding

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

sample size of 30- First group of 15 subjects recording of plaque and gingival scores were recorded. Patients were given first dentifrice and asked to brush for 72 hours and then asked to report. A washout period of 2 weeks followed. The next round, the subjects were given the second dentifrice and asked to brush for 72 hrs and then after a period of 3days asked to report

Masking

ParticipantCare Provider

Masking Description

Both the participant and the care provider were masked. They were unaware of the paste they were using as it was marked alphanumerically

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

moringa

Arm Type

Active Comparator

Arm Description

First phase of subjects were given dentifrice for brushing

Arm Title

miswak

Arm Type

Active Comparator

Arm Description

second phase of subjects were given dentifrice for brushing

Intervention Type

Other

Intervention Name(s)

dentifrice

Intervention Description

use of dentifrices for brushing

Primary Outcome Measure Information:

Title

plaque scores

Description

plaque score recorded using calibrated periodontal probes

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Gingival inflammation scores

Description

Gingival bleeding scores recorded using caliberated periodontal probes

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

AB shetty Institute of dental sciences

City

Mangaluru

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis

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