Clinical trial NCT03004196: Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans
Official title: Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: Peoples University, Bhanpur, Bhopal
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Bhopal
country: India
facility: Peoples College Of Dental Science & Research Center
state: Madhya Pradesh
Study officials:
affiliation: Peoples University
name: Dr.Chandrika Dubey, MDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.