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Antiplaque Efficacy of Two Novel Commercially Available Herbal Toothpastes.

Primary Purpose

Gingivitis, Plaque, Dental

Status
Completed
Phase
Phase 1
Locations
United Arab Emirates
Study Type
Interventional
Intervention
salvadora
Eucalyptus Oil
Sponsored by
Ajman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gingivitis focused on measuring gingivitis, dental plaque, herbal, dentifrice, miswak, eucalyptol

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Ajman University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

miswak

eucalyptus oil

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Plaque score
The plaque 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.

Full Information

First Posted
April 26, 2022
Last Updated
May 3, 2022
Sponsor
Ajman University
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1. Study Identification

Unique Protocol Identification Number
NCT05363956
Brief Title
Antiplaque Efficacy of Two Novel Commercially Available Herbal Toothpastes.
Official Title
Antiplaque Efficacy of Two Novel Commercially Available Herbal Toothpastes.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The Ajman University Ethical Committee accepted the current randomized trial; the reference number is (D-H-S-2021-NOV-24-19). The research was conducted from January 1, 2022, to March 1, 2022. The current study was carried out following CONSORT standards and the Helsinki Declaration as updated in 2013. The following kinds of toothpaste were used in this randomized crossover clinical study: Miswak toothpaste (Dabur, India) contains contains primarily miswak, with traces of other elements; Eucalyptus toothpaste (Eucalyptus-Bio (Argiletz, France)) contains primarily eucalyptus, with traces of other elements Patient Selection The PS program online version 3.16 (power and sample size calculations) was used to calculate the sample size. The inclusion criteria included subjects who are medically fit, subjects with gingival inflammation not progressed into periodontitis, and subjects between the age of 20-and 60 years. The exclusion criteria included subjects who are medically compromised, subjects on active treatment of antibiotics and corticosteroids, subjects with periodontitis (according to the AAP 2017 classification), subjects who have undergone a periodontal therapy for the past 3 months, and subjects who are healthy but have been using herbal dentifrices. A total of 120 subjects were examined However, only Thirty gingivitis patients and thirty healthy patients to be used as a control met the inclusion criteria. Study Design This crossover randomized single-blinded study was conducted with a 20-day total examination period. The individuals were informed in great detail about the necessity for clinical evaluation for research objectives, and a signed agreement was acquired. A sample size of 30 patients with gingivitis was selected and the other 30 patients without gingivitis were used as a control. Randomization to which study group participants will belong was done by drawing lots into either the test 1 (Dabur Miswak, India), test 2(Eucalyptus-Bio, Argiletz, France), or the Active control group. To achieve blinding, serial opaque cardboard boxes with pre-assigned numbers corresponding to the Lot randomization code will be utilized to assign participants to their appropriate groups. After being assigned to their respective groups, the participants were blinded. On the first (baseline) day of the trial, all individuals were subjected to an oral examination. The baseline score was obtained for patients who met the inclusion criteria at the beginning of the study and followed up throughout the study. 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. The Oral hygiene index(Plaque index) 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 (OHIS, Greene & Vermillion, 1962) and the Gingival index of all teeth (Loe and Silness 1963) were recorded at the initial appointment (baseline) in the morning. 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. Following that, subjects were instructed to use miswak toothpaste twice a day for three days. Plaque and gingival bleeding scores were evaluated again after 72 hours. The 3 days study design was developed by Marchetti et al study the 3-day plaque accumulation model to compare the efficiency of essential oil mouthwash with and without alcohol instead of kinds of toothpaste. (Marchetti, E. et al., 2011) Another study was performed by Duarte, K. et al. in 2022 and followed the 3 days plaque accumulation model to compare the efficiency of two herbal kinds of toothpaste with closely resembles our study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Plaque, Dental
Keywords
gingivitis, dental plaque, herbal, dentifrice, miswak, eucalyptol

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Masking Description
Patients were not told which dentifrice they will be given
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
miswak
Arm Type
Active Comparator
Arm Description
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.
Arm Title
eucalyptus oil
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
salvadora
Other Intervention Name(s)
Miswak
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Eucalyptus Oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gingivitis Bleeding score
Description
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.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Plaque score
Description
The plaque 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.
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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Medically fit gingivitis patients subjects between 20-60 years of age Exclusion Criteria: systemically compromised subjects who had undergone periodontal treatment in the last 6 months subjects using herbal dentifrice subjects having periodontal disease
Facility Information:
Facility Name
Ajman University
City
Ajman
ZIP/Postal Code
009716
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared among those researchers who are interested
IPD Sharing Time Frame
The data will be shared immediately
IPD Sharing Access Criteria
via email

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Antiplaque Efficacy of Two Novel Commercially Available Herbal Toothpastes.

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