Role of Herbal Based Mouthwashes in Plaque Control (mouthwash)

November 28, 2024 updated by: sudhir rama varma, Ajman University

Role of Herbal Based Mouthwashes in Plaque Control. a Randomized Clinical Control Trial

Herbal medicine has been used for thousands of years. Traditional herbal medicine is used by an estimated 80% of the world's population for primary health care. Herbal treatments have gained popularity as a dietary supplement for illness prevention and as an alternative/complementary therapy in recent years. Herbal remedies come in a wide variety of forms and can be found on the market all over the world.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Herbal mouthwashes have been increasingly popular over time. Ethnomedicines are the term used to describe them. Various substances have been tested, with phytopharmacological analyses yielding contradictory results. Many previous studies had tested the antiplaque efficiency of one herbal mouthwash with contradicting results, other studies have tested the Antiplaque efficiency of chlorhexidine, tea tree oil and Miswak, some studies had given positive outcomes and benefits of Miswak on the gingiva and others when comparing between the efficacy of Miswak over chlorhexidine mouth wash in dental practice provided results favouring both these mouthwashes.

In our proposed study we will compare the antiplaque efficiency of three herbal kinds of mouthwash, Miswak, tea tree oil and Resveratrol mouthwash. Plaque and gingival bleeding scores will be taken before the study from 6 different teeth and retaken after 2 weeks and four weeks respectively the use of the mouthwash. This study is single-blinded. Antiplaque and gingival bleeding scores from the three mouthwashes will be recorded over a period of a month and statistical analysis will be performed

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are medically fit
  • Patients with gingival inflammation not progressed into periodontitis (AAP classification
  • Patients between the age of 18-60 years

Exclusion Criteria:

  • Patients who are medically compromised
  • Patient who have undergone a periodontal therapy for the past 3 months
  • Patients who are healthy but have been using herbal mouthwashes

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chlorhexidine
Mouthwash will be used for these participants
Other: Mouthwash Product
  • In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft).
  • They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores.
Other Names:
  • chlorhexidine
  • tea tree oil
  • resverotriol
  • miswak
Active Comparator: Tea tree oil
Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks
Other: Mouthwash Product
  • In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft).
  • They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores.
Other Names:
  • chlorhexidine
  • tea tree oil
  • resverotriol
  • miswak
Active Comparator: Reseverotriol
Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks
Other: Mouthwash Product
  • In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft).
  • They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores.
Other Names:
  • chlorhexidine
  • tea tree oil
  • resverotriol
  • miswak
Active Comparator: Miswak
Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks
Other: Mouthwash Product
  • In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft).
  • They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores.
Other Names:
  • chlorhexidine
  • tea tree oil
  • resverotriol
  • miswak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plaque score
Time Frame: From Baseline-pre-intervention to the end of treatment at 4 weeks
To assess the plaque score
From Baseline-pre-intervention to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gingival bleeding score
Time Frame: from pre-intervention to the end of the treatment at 4 weeks
To assess gingival bledding score
from pre-intervention to the end of the treatment at 4 weeks

Collaborators and Investigators

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

Sponsor

Ajman University

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 (Estimated)

December 20, 2024

Primary Completion (Estimated)

February 20, 2025

Study Completion (Estimated)

March 20, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ajman Herbal mouthwash 2425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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