A clinical trial two study the effects of two toothpaste Probiotic and Aloe vera in patients with braces on teeth.

Completed

• Conditions: Medically fit patients undergoing fixed orthodontic treatment with no medical history and relevant drug history.

• Registration Number: CTRI/2018/04/013020
• Lead Sponsor: Afzal K Nazim

Brief Summary

This is a randomized, double blinded, controlled study which  aims to evaluate and compare the effects of Probiotic toothpaste and Aloe Vera tooth gel in the reduction of *streptococcus mutans* level in plaque around orthodontic brackets. A total of 60 randomly selected orthodontic patients will be enrolled in this study. They will be divided into 3 groups of 20 each. Group I is the control group using the regular fluoride toothpaste . Patients in group II will be asked to use Probiotic toothpaste and group III patients will be asked to use Aloe vera tooth gel. All the patients will be asked to brush their teeth twice daily in the morning and evening for a time period of 30 days.Samples will be collected at 2 times: before the study began and after 30 days. Plaque specimens will be  collected from the labial surfaces immediately surrounding the orthodontic brackets of the maxillary lateral incisor using a 4-pass technique. The quantification of S.mutans will be  evaluated using quantitative real time polymerase chain reaction.Cycle threshold value (Ct) is the primary outcome. Intragroup and intergroup analysis will be done based on the Ct value.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Study Completion: 2016-10-31
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Orthodontic treatment with straight wire appliance.
• Permanent dentition with full compliment of teeth excluding third molars.
• No relevant medical history.
• No anti-inflammatory or antibiotic medications taken in the month before and during the study.
• No chewing gum or mouthwash usage in the week preceding and during the study.
• Habit of brushing twice daily with fluoride toothpaste.
• Age between 12 and 35 years.
• 8.Fixed orthodontic treatment started atleast 6 months before sample collection.

Exclusion Criteria

• Mixed dentition.
• Previous history of orthodontic treatment.
• Tooth with developmental anomalies and fluorosis.
• Restoration involving labial surface of tooth.
• Pregnancy, lactation and diabetics 6.
• Patients with habit of smoking.
• Patient allergic to aloe vera.
• Tendency for frequent vomiting.
• Participants with unavoidable drug intake during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cycle threshold value (Ct)	30 days

Secondary Outcome Measures

Name	Time	Method
Cycle threshold value (Ct)	Ct value before intervention and after 30 days

Trial Locations

Locations (1)

Pushpagiri College od Dental Sciences; 🇮🇳 Pathanamthitta, KERALA, India

Pushpagiri College od Dental Sciences

🇮🇳Pathanamthitta, KERALA, India

Afzal K Nazim

Principal investigator

9809837779

afzee.7779@gmail.com