Role of Herbal Based Mouthwashes in Plaque Control (mouthwash)

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: Plaque Induced Gingival Disease
• Intervention / Treatment: Other: Mouthwash Product

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

• Study Contact: Name: sudhir Rama Varma, MDS; Phone Number: 971506595075; Email: sudhir2002@hotmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	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	To assess gingival bledding score	from pre-intervention to the end of the treatment at 4 weeks

Collaborators and Investigators

• Sponsor: Ajman University

Study record dates

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: chlorhexidine; plaque; resveratrol; miswak; gingival bleeding; tea tree oil
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Anti-Infective Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine; Tea Tree Oil
• 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