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CTRI Number  CTRI/2018/10/016100 [Registered on: 22/10/2018] Trial Registered Prospectively
Last Modified On: 15/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   a clinical trial comparing the effectiveness of two mouthrinses to treat gum diseases in patients undergoing fixed orthodontic treament 
Scientific Title of Study   A Randomized Controlled trial to evaluate the Effectiveness of freshly prepared Synbiotic Mouthwash vs freshly prepared Probiotic Mouthwash as an Adjunct to Scaling in Patients with Plaque induced gingivitis along with Fixed Orthodontic Appliances” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikita Patil 
Designation  2nd Year postgraduate  
Affiliation  Nair Hospital Dental college 
Address  202, second floor,Nair Hospital Dental College, Opposite Maratha mandir, Mumbai Central -08

Mumbai (Suburban)
MAHARASHTRA
400008
India 
Phone  9699696160  
Fax    
Email  patilnikii19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mala Dixit Baburaj 
Designation  HOD and Professor, Dept of Periodontics 
Affiliation  Nair Hospital Dental college 
Address  202, second floor,Nair Hospital Dental College, Opposite Maratha mandir, Mumbai Central -08

Mumbai
MAHARASHTRA
400008
India 
Phone    
Fax    
Email  maladixit25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikita Patil 
Designation  2nd Year postgraduate  
Affiliation  Nair Hospital Dental college 
Address  202, second floor,Nair Hospital Dental College, Opposite Maratha mandir, Mumbai Central -08

Mumbai
MAHARASHTRA
400008
India 
Phone  9699696160  
Fax    
Email  patilnikii19@gmail.com  
 
Source of Monetary or Material Support  
Nair Hospital Dental college, Mumbai Central. Mumbai 400008 
 
Primary Sponsor  
Name  Dr Nikita Patil 
Address  202, Nair hospital dental college, Mumbai 08 
Type of Sponsor  Other [self sponsored study] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikita Patil  Nair hospital dental college  202, second floor,Nair Hospital Dental College, Opposite Maratha mandir, Mumbai Central -08
Mumbai (Suburban)
MAHARASHTRA 		 9699696160

patilnikii19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-NHDC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R68||Other general symptoms and signs, (2) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  probiotic mouthrinse 10 ml twicwdaily for 30 days  good bacteria 
Intervention  synbiotic mouthrinse 10 ml twicwdaily for 30 days  fertilizer to probiotic  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Minimum of 20 teeth should be present in the dentition .
2) Patients with fixed orthodontic appliances
3) Patients classified as stage II and stage III gingivitis based upon the gingival score given by Loe and Silness 1964.
4)Patient with clinical bleeding on probing present.
5) Patient willing to give the informed consent and willing to comply with the study were selected
 
 
ExclusionCriteria 
Details  1)Allergy or hypersensitivity to Chlorhexidine or related compounds.
2)Use of antibiotics within last 3 months.
3)Periodontal pockets >4mm.
4)systemic diseases.
5)Pregnancy.
6)Smoking
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
3. To Compare the efficacy of freshly prepared synbiotic mouthrinse and freshly prepared probiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances  baseline, 1month. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To Compare the efficacy of Chlorhexidine mouthrinse(0.12%) and freshly prepared probiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances
2. To Compare the efficacy of Chlorhexidine mouthrinse(0.12%) and freshly prepared Synbiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances patients
 		 baseline, 1month. 
4. To Compare the efficacy of warm saline rinse and all of the above on plaque induced gingivitis in patient with fixed orthodontic appliances  baseline, 1month. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/11/2018 
Date of Study Completion (India) 01/02/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/02/2019 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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
Modification(s)  

AIM OF STUDY:

To evaluate the Effectiveness of freshly prepared Synbiotic Mouthwash vs freshly prepared Probiotic Mouthwash as an Adjunct to Scaling in Patients with Plaque induced gingivitis along with Fixed Orthodontic Appliances

OBJECTIVES OF THE STUDY:

1. To Compare the efficacy of Chlorhexidine mouthrinse(0.12%) and freshly prepared probiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances

2. To Compare the efficacy of Chlorhexidine mouthrinse(0.12%) and freshly prepared Synbiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances patients

3. To Compare the efficacy of freshly prepared synbiotic mouthrinse and freshly prepared probiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances

4. To Compare the efficacy of warm saline rinse and all of the above on plaque induced gingivitis in patient with fixed orthodontic appliances

STUDY DESIGN

The patients fitting in   the inclusion criteria will be divided into four groups using Computer assisted randomization –

Group A, Group B, Group C and Group D

a) Group A: Scaling along with Chlorhexidine mouthrinse(0.12%) (n=20)

b) Group B : Scaling along with freshly prepared Probiotic Mouth rinse (n=20)

c) Group C: Scaling along with freshly prepared Synbiotic mouthrinse (n=20)

d)Group D: Scaling along with warm saline rinse(n=20)

Scaling will be done on all sides using Utrasonic Scaler

Clinical parameters:-

The following clinical parameters were recorded at baseline before ultrasonic scaling in every patient by the examiner:-

1. Gingival index (Loe and Silness-1964)14

2. Papilla bleeding index (Muhlemann-1977)15

3. Bonded bracket plaque index (Kilicoglu et al.) 16

4. Stains- present /absent assessed with the help of magnifying glass

Procedure:

Following initial examination and treatment planning, the subjects will be divided into

Groups A,B,C & D. Those in Group A, B, C and D will be explained to undergo thorough

scaling and root planing (SRP).The patients will be allocated in Groups using computer generated randomization method.

 

The following instruction will be given to the patient for the use of mouthrinse

1.    The patient will be advised to brush with the toothbrush and toothpaste with modified Bass technique twice daily. Modified Bass technique will be demonstrated to the patients.

2.    The patient will be advised to use 10ml of mouthrinse 30 mins after toothbrushing.

3.    This mouthrinse should be used twice daily for 1 month

4.    Patient will be advised not to eat/drink/rinse/brush 30 mins after the use of mouthrinse.


 
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