| CTRI Number |
CTRI/2018/04/013020 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry
Other (Specify) [Aloe vera] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial two study the effects of two toothpaste Probiotic and Aloe vera in patients with braces on teeth. |
|
Scientific Title of Study
|
Comparative evaluation of probiotic toothpaste and aloe vera tooth gel in reducing streptococcus mutans level in plaque around orthodontic brackets: A randomized controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Afzal K Nazim |
| Designation |
Post Graduate Resident |
| Affiliation |
Pushpagiri College of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room no:6,Pushpagiri College of Dental Sciences,Medicity, Perumturuthy P O,Thiruvalla,Pathanamthitta District,Kerala,
PIN 689107
Pathanamthitta
KERALA
689107
India |
| Phone |
9809837779 |
| Fax |
|
| Email |
afzee.7779@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biju Sebastian |
| Designation |
Professor and Head of Department |
| Affiliation |
Pushpagiri College of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopedics,
Room no:6,Pushpagiri College Of Dental Sciences, Medicity,
Perumturuthy P O, Thiruvalla, Pathanamthitta District,
Kerala, PIN 689107
Pathanamthitta
KERALA
689107
India |
| Phone |
9446539062 |
| Fax |
|
| Email |
drbijuseb00@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Afzal K Nazim |
| Designation |
Post Graduate Resident |
| Affiliation |
Pushpagiri College of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopedics,Room no:6,Pushpagiri College of Dental Sciences,Medicity, Perumturuthy P O,Thiruvalla,Pathanamthitta District,Kerala
PIN 689107
Pathanamthitta
KERALA
689107
India |
| Phone |
9809837779 |
| Fax |
|
| Email |
afzee.7779@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pushpagiri College of Dental Sciences
Medicity
Perumturuthy P O
Thiruvalla
Pathanamthitta District
Kerala
PIN 689107 |
| Pushpagiri Research Centre
Pushpagiri Medical College Campus
Thiruvalla P O
Pathanamthitta District
Kerala
PIN 689101 |
|
|
Primary Sponsor
|
| Name |
Afzal K Nazim |
| Address |
Valel Gardens
P V North
Thazhava P O
Karunagappally
Kollam
Kerala
PIN 690523 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Afzal K Nazim |
Pushpagiri College od Dental Sciences |
Department of Orthodontics and Dentofacial Orthopedics
Room no:6
Medicity
Perumturuthy P O
Thiruvalla
Pathanamthitta
Kerala
PIN 689107
Pathanamthitta
KERALA |
9809837779
afzee.7779@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Medically fit patients undergoing fixed orthodontic treatment with no medical history and relevant drug history., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ALOE VERA TOOTH GEL |
Topical application on teeth while brushing 2 times daily in morning and evening for a time period of 30 days. |
| Comparator Agent |
FLUORIDATED TOOTHPASTE |
Topical application on teeth while brushing 2 times daily in morning and evening for a time period of 30 days. |
| Intervention |
PROBIOTIC TOOTHPASTE |
Topical application on teeth while brushing 2 times daily in morning and evening for a time period of 30 days. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Orthodontic treatment with straight wire appliance.
2. Permanent dentition with full compliment of teeth excluding third molars.
3. No relevant medical history.
4. No anti-inflammatory or antibiotic medications taken in the month before and during the study.
5. No chewing gum or mouthwash usage in the week preceding and during the study.
6. Habit of brushing twice daily with fluoride toothpaste.
7. Age between 12 and 35 years.
8.Fixed orthodontic treatment started atleast 6 months before sample collection. |
|
| ExclusionCriteria |
| Details |
1. Mixed dentition.
2. Previous history of orthodontic treatment.
3. Tooth with developmental anomalies and fluorosis.
4. Restoration involving labial surface of tooth.
5. Pregnancy, lactation and diabetics
6. Patients with habit of smoking.
7. Patient allergic to aloe vera.
8. Tendency for frequent vomiting.
9. Participants with unavoidable drug intake during the study period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cycle threshold value (Ct) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cycle threshold value (Ct) |
Ct value before intervention and after 30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2016 |
| Date of Study Completion (India) |
31/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |