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

NCT ID: NCT03004196

Last Updated: 2016-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-10-31

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).

Conditions

White Spot Lesion of Tooth; Long Term Adverse Effects; Caries, Dental; Orthodontic Appliance Complication

Keywords

White Spot Lesion; Probiotics; Chlorhexidine; Streptococcus Mutans; Fixed Orthodontic Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

They were not given probiotic toothpaste or chlorhexidine mouthwash

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

No Probiotic toothpaste \& Chlorhexidine Mouthwash

Probiotic Group

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.

Group Type: EXPERIMENTAL

Probiotic Toothpaste

Intervention Type: DRUG

G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria

Chlorhexidine Mouthwash Group

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.

Group Type: EXPERIMENTAL

Dr. Reddy's Clohex

Intervention Type: DRUG

0.20% Chlorhexidine Mouthwash

Interventions

Probiotic Toothpaste

G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria

Intervention Type: DRUG

Dr. Reddy's Clohex

0.20% Chlorhexidine Mouthwash

Intervention Type: DRUG

Control Group

No Probiotic toothpaste \& Chlorhexidine Mouthwash

Intervention Type: OTHER

Other Intervention Names

G.D Probiotic Toothpaste; Chlorhexidine Mouthwash

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peoples University, Bhanpur, Bhopal

OTHER

Sponsor Role: lead

Responsible Party

Chandrika Dubey

Post-Graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr.Chandrika Dubey, MDS

Role: PRINCIPAL_INVESTIGATOR

Peoples University

Locations

Peoples College Of Dental Science & Research Center

Bhopal, Madhya Pradesh, India

Countries

India

References

Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72. doi: 10.1016/j.ajodo.2013.02.023.

Reference Type: BACKGROUND

PMID: 23810047 (View on PubMed)

Other Identifiers

CD-01

Identifier Type: -

Identifier Source: org_study_id