A clinical trial to compare the effects of 2 mouthwashes - Green tea herbal mouthwash and 0.2 % chlorhexidine mouthwash against dental caries causing Streptococcus mutans microorganism in children.

Completed

Conditions: Children with plaque scores between 1and 2 , and gingival scores from 0 to 2 andDMFT / deft score from 0 to 3 and similar oral hygiene practices.
Dental caries, unspecified,

Registration Number: CTRI/2021/11/037903

Lead Sponsor: Dr Aarcha S Kumar

Brief Summary: NEED FOR STUDY:

The progression of dental caries is governed by acidogenic gram-positive bacteria

mainly Streptococcus mutans which convert sucrose to organic acids, that dissolve the

calcium phosphate in teeth and eventually lead to decalcification and decay. Several agents

are available that can alter the profile of oral microflora but can cause undesirable effects. 1

The Gold Standard 0.2% Chlorhexidine gluconate has many disadvantages like extrinsic

tooth staining, calculus build up, transient taste disturbance, soreness of oral mucosa,

irritation, mild desquamation and mucosal ulceration/erosions and a general burning

sensation or a burning tongue or both. 2 Some herbal mouthwashes like aloe vera and tea tree

oil have been proved to be comparable to 0.2% chlorhexidine gluconate in their efficacy . 3

Green tea (Camellia sinensis), which contains adequate amounts of catechins and various

other polyphenol compounds, has been shown to possess antibacterial, antioxidant, anti-

inflammatory, antidiabetic, antiviral, antimutagenic properties with a proper efficacy along

with anti caries and anti bacterial against periodontal pathogens. 4 There is paucity of

comparative studies on antimicrobial efficacy of Green tea herbal mouthwash and gold

standard 0.2% chlorhexidine gluconate in dental plaque.

In the light of these factors, in this study we are comparing the antimicrobial efficacy of

commercially available green tea herbal mouth wash (Camellia sinensis) with 0.2 %

chlorhexidine gluconate mouthwash( gold standard) in dental plaque .

RESEARCH QUESTION

Is green tea herbal mouthwash more efficacious than 0.2% chlorhexidine gluconate against

Streptococuus mutans in dental plaque ?

RESEARCH HYPOTHESIS

Green tea herbal mouthwash is more efficacious than 0.2% chlorhexidine gluconate

against Streptococcus mutans in dental plaque.

METHODOLOGY

A double- blind clinical trial will be conducted. After taking informed consent from the

institutional authorities, children from 2 different schools will be screened according to the

inclusion and exclusion criteria and 15 participants each from 2 different schools will be

selected for assigning 2 different mouthwash. Informed consent from the parents /

guardians and informed assent from the participants will be taken. .

Plaque collection will be done in the morning by a single operator trained in pediatric

dentistry. All samples will be collected in the morning between 9.00 a.m to 11.00 a.m.

Baseline plaque samples will be collected using a sterile explorer from the buccal surface of

first permanent molars. Participants will be asked to swallow just before plaque collection

to minimise salivary contamination and during sample collection care will be taken to avoid

contamination with blood or saliva. 8 The tooth surfaces will be patted with cotton to absorb

saliva before collecting plaque to avoid salivary contamination. Collection will be

standardized by using four occlusally directed strokes. 9 Children will be instructed not to eat

or drink anything (except water) 1h before plaque collection . The plaque will be placed in

microcentrifuge tube and then

transported within an hour to laboratory via box containing dry ice to maintain adequate

temperature. Later the samples will be placed in 1ml Brain-Heart Infusion (BHI) culture

medium. Afterwards, the samples will be cultured in MSB specific medium containing 0.2

units per milliliter Bacitracin. The numbers of the S. mutans colonies grown in Bacitracin

culture medium will be counted.

Mouth rinse bottles containing 140 ml of mouthwash will be given to the participants. The

mouth rinse bottles given to the participants will be masked. Prior to the usage of

mouthwash, the children will be demonstrated the rinsing procedure. Participants will be

instructed to use 10 ml of the mouthwash for 60 seconds twice daily, after brushing, in the

morning and at night (just before bed) for 15 days. A 10 ml measuring cup will be provided

for the same. During the course of clinical trial compliance will be evaluated and any

adverse effects will be asked to be reported on a daily basis via phone calls. Guardians will

be instructed to supervise daily proper use of the mouth rinse and also see that for a

minimum of half an hour after rinsing the child should not eat or drink anything. A

checklist will be provided to stick colourful stickers on days children have used mouthwash

and put X on days they didnâ€™t. Participants compliance will be assessed by the investigator

on day 7. The mouth rinse bottles containing 140 ml of mouthwash will be resupplied on 7

th day to all the participants.

The participantsâ€™ compliance will be evaluated by measuring the remaining volume of the

mouth wash that they brought back on 15th day and also the checklist . All children will be

reviewed on 15th day to collect the plaque samples once again using the same procedure

as mentioned above for evaluation of antimicrobial efficacy. All the participants will

undergo oral prophylaxis, oral hygiene instructions and dietary instructions. Base line and

the follow up data thus obtained, will be statistically analysed and compared .

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

CHILDREN WHO ARE CAPABLE OF MAINTAINING ORAL HYGIENE THEMSELVES 2.
CHILDREN IN LATE MIXED DENTITION 3.CHILDREN WITH PLAQUE SCORES BETWEEN 1 AND 2 , GINGIVAL SCORES BETWEEN 0 TO 2, DMFTdeft SCORES FROM 0 TO 3 AND SIMILAR ORAL HYGIENE PRACTICES.

Exclusion Criteria

CHILDREN WHO HAVE RECENTLY USED ANY MOUTHWASH, TOPICAL FLUORIDE OR ANTIBIOTICS IN THE PAST 1 MONTH.
CHILDREN WITH RAMPANT CARIES INVOLVING DENTAL PULP OR WITH SYSTEMIC DISEASES 3.
SPECIALLY ABLED CHILDREN 4.
CHILDREN WITH ORTHODONTIC APPLIANCES OR PROSTHESIS 5.
CHILDREN WITH ANY KNOWN ALLERGIES AND ALLERGIES TO MOUTHWASH ASSIGNED.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
REDUCTION OF STREPTOCOCCUS MUTANS COUNT IN DENTAL PLAQUE	15 Days

Secondary Outcome Measures

Name	Time	Method
Improvement of Oral hygiene status	15 Days

Trial Locations

Locations (1): GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE
🇮🇳
Bangalore, KARNATAKA, India
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE
🇮🇳Bangalore, KARNATAKA, India
Dr Aarcha S Kumar
Principal investigator
9738462097
avsisters@gmail.com