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 didn’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 participants’ 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 . |