Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans

Phase 1

Completed

• Conditions: Orthodontic Appliance Complication; Long Term Adverse Effects; White Spot Lesion of Tooth; Caries, Dental
• Interventions: Other: Control Group; Drug: Probiotic Toothpaste; Drug: Dr. Reddy's Clohex

• Registration Number: NCT03004196
• Lead Sponsor: Peoples University, Bhanpur, Bhopal

Brief Summary

Orthodontic appliance causes increase in plaque accumulation, especially around brackets, wires and attachments. Advances in orthodontics in recent time have led to improved quality of appliance and treatment procedures ultimately resulting in improvised standard of patient care.

These bacteria metabolize different kind of carbohydrates accumulated around orthodontic appliances and create acidic environment in the oral cavity leading to enamel demineralization around the brackets and white spot lesions.

This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are not using them.

Detailed Description

INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where plaque gets accumulated, especially around brackets, bands, wires, and other attachments; this facilitates the development of white spot lesions. Probiotics act by competitively inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental plaque around orthodontic appliances. AIM \& OBJECTIVE - The objectives of the study is to evaluate and compare the effects of the topical application of probiotic toothpaste and chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic patients hence improving the oral micro-flora of oral cavity by competitive inhibition of Streptococcus Mutans in plaque present around brackets.

MATERIAL \& METHOD - The study consists of thirty randomly selected orthodontic patients undergoing fixed appliance treatment. The patients were divided into three groups - Control Group (Group 1), Probiotic Toothpaste Group (Group 2) \& Chlorhexidine Mouthwash Group (Group 3). Samples were collected at two times interval: before the study began (Phase 1) and after thirty days (Phase 2).

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-22
• Last Update Submitted: 2016-12-22
• Study First Posted: 2016-12-28
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Orthodontic Treatment With The Straight Wire Appliance (MBT, 0.022-in Slot; 3M Unitek, Monro- Via, Calif), Permanent Dentition (Excluding Third Molars)
• Good General Health (No Significant Medical History Or Drug Use During The Last Month)
• No Anti-inflammatory Or Antibiotic Medications Taken In The Month Before The Study
• No Chewing Gum Or, Mouthwash Used In The Last Week And During The Study
• Habit Of Brushing Twice Daily With Fluoride Toothpaste

Exclusion Criteria

-Patient with poor periodontal condition Patient with known medical condition e.g. Subacute bacterial, endocarditis , diabetes, valvular disease ,anaemia etc

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	They were not given probiotic toothpaste or chlorhexidine mouthwash
Probiotic Group	Probiotic Toothpaste	Patients were asked to brush twice daily with given "G.D Probiotic Toothpaste" and were asked not to eat or drink anything for half-an-hour.
Chlorhexidine Mouthwash Group	Dr. Reddy's Clohex	Patients were asked to rinse daily with "Dr. Reddy's Clohex" chlorhexidine mouthwash of 10ml without dilution for three times a day after meals (Breakfast, Lunch Dinner) for 3-4 minutes and were asked not to eat or drink anything for half-an-hour.

Primary Outcome Measures

Name	Time	Method
Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash	1 Month	Probiotic Toothpaste \& Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group

Trial Locations

Locations (1)

Peoples College Of Dental Science & Research Center; 🇮🇳 Bhopal, Madhya Pradesh, India