Antiplaque Efficacy of Two Novel Commercially Available Herbal Toothpastes.

NCT05363956 | Completed Phase 1 DMC

• 1 other identifier: D-H-S-2021-NOV-24-19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Maintaining proper oral hygiene is essential in the prevention of oral as well as general illness. The use of herbal medicine in dentistry is growing exponentially over the years. Today, herbal medicine is considered an effective alternative to manufactured medication. The objective of this current randomized control study is to assess the anti-plaque efficiency of Miswak (Salvadora Persica) and Eucalyptus toothpaste in the treatment of gingivitis. Materials and Methods: This randomized experimental study enrolled 30 healthy individuals as controls and 30 individuals with mild to moderate gingivitis. The study lasted 20 days and included a two-week washout period between Miswak and Eucalyptus toothpaste. The gingival and plaque index were measured at specific time intervals during the research period.

Conditions

Gingivitis; Plaque, Dental

Keywords

gingivitis; dental plaque; herbal; dentifrice; miswak; eucalyptol

Outcome Measures

Primary Outcomes (1)

• Gingivitis Bleeding score

  The Gingivitis bleeding score of the facial surface of three maxillary teeth, the lingual surface of the two posterior mandibular teeth, and the labial surface of one anterior mandibular tooth were calculated at the initial appointment (baseline) in the morning and 72 hours later. All examinations were performed in the morning and by the same examiner at all recall visits, as this helps in reducing the risk of bias and quantifying the results.

  72 hours

Secondary Outcomes (1)

• Plaque score

  72 hours

Study Arms (2)

miswak

ACTIVE COMPARATOR

The participants were given a dentifrice that had been labeled and tagged with a number. All participants were asked to brush their teeth twice daily with a 1cm line of paste in their respective brushes for two minutes, once in the morning and the other at night, using the modified bass technique. The technique will be demonstrated to the patient and an image of the technique provided to the participants.

Drug: salvadora; Drug: Eucalyptus Oil

eucalyptus oil

ACTIVE COMPARATOR

The participants were given a dentifrice that had been labeled and tagged with a number. All participants were asked to brush their teeth twice daily with a 1cm line of paste in their respective brushes for two minutes, once in the morning and the other at night, using the modified bass technique. The technique will be demonstrated to the patient and an image of the technique provided to the participants.

Drug: salvadora; Drug: Eucalyptus Oil

Interventions

salvadora DRUG

The participants were given a dentifrice that had been labeled and tagged with a number. All participants were asked to brush their teeth twice daily with a 1cm line of paste in their respective brushes for two minutes, once in the morning and the other at night, using the modified bass technique.

Also known as: Miswak

eucalyptus oil; miswak

Eucalyptus Oil DRUG

The participants were given a dentifrice that had been labeled and tagged with a number. All participants were asked to brush their teeth twice daily with a 1cm line of paste in their respective brushes for two minutes, once in the morning and the other at night, using the modified bass technique.

eucalyptus oil; miswak

Eligibility Criteria

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

You may qualify if:

• Medically fit
• gingivitis patients
• subjects between 20-60 years of age

You may not qualify if:

• systemically compromised
• subjects who had undergone periodontal treatment in the last 6 months
• subjects using herbal dentifrice
• subjects having periodontal disease

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

Ajman University

Ajman, 009716, United Arab Emirates

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Interventions

Eucalyptus Oil

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were not told which dentifrice they will be given
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The participants were given a dentifrice that had been labeled and tagged with a number. All participants were asked to brush their teeth twice daily with a 1cm line of paste in their respective brushes for two minutes, once in the morning and the other at night, using the modified bass technique. The technique will be demonstrated to the patient and an image of the technique provided to the participants.

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 6, 2022
• Study Start: September 1, 2021
• Primary Completion: November 15, 2021
• Study Completion: December 20, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be shared immediately
• Access Criteria: via email

Locations

AE (1)