Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis

NCT04830176 | Completed

• 1 other identifier: D-F-19-03-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingiva; Infection; Plaque, Dental

Keywords

miswak; moringa; plaque; gingival bleeding

Outcome Measures

Primary Outcomes (1)

• plaque scores

  plaque score recorded using calibrated periodontal probes

  72 hours

Secondary Outcomes (1)

• Gingival inflammation scores

  72 hours

Study Arms (2)

moringa

ACTIVE COMPARATOR

First phase of subjects were given dentifrice for brushing

Other: dentifrice

miswak

ACTIVE COMPARATOR

second phase of subjects were given dentifrice for brushing

Other: dentifrice

Interventions

dentifrice OTHER

use of dentifrices for brushing

miswak; moringa

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• subjects having only plaque induced gingival inflammation

You may not qualify if:

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

Sponsors & Collaborators

• Ajman University: lead
• A B Shetty Memorial Institute of Dental Science: collaborator

Study Sites (1)

AB shetty Institute of dental sciences

Mangaluru, India

Location

MeSH Terms

Conditions

Infections; Dental Plaque; Plaque, Amyloid; Gingival Hemorrhage

Interventions

Dentifrices

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Oral Hemorrhage; Mouth Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both the participant and the care provider were masked. They were unaware of the paste they were using as it was marked alphanumerically
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: January 20, 2021
• Primary Completion: March 20, 2021
• Study Completion: March 28, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data can be accessible in a months time. The data will have unrestricted time frame

Locations

IN (1)