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CTRI Number  CTRI/2018/05/013597 [Registered on: 02/05/2018] Trial Registered Prospectively
Last Modified On: 01/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry
Process of Care Changes 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Useful bacteria and laser in Gum Disease 
Scientific Title of Study   Efficacy of local application of probiotics with and without photodynamic therapy as an adjunct to scaling and root planing a clinico microbiological study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vellampalli udhaya bhanu  
Designation  Post graduate 
Affiliation  Narayana dental college and hospital 
Address  Department of periodontology Room no 2 second floor Narayana dental college and hospital chintareddy palem nellore
Department of periodontology Room no 2 second floor Narayana dental college and hospital chintareddy palem nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  8074685129  
Fax    
Email  udayabhanuvelampalli@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B V Ramesh Reddy  
Designation  professor  
Affiliation  Narayana dental college and hospital 
Address  Department of periodontology Narayana dental college and hospital Room no 5 second floor chintareddy palem nellore
epartment of periodontology narayana dental college and hospital Room no 5 second floor chintareddy palem nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  9849798990  
Fax    
Email  perioramesh@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr BV Ramesh Reddy  
Designation  professor  
Affiliation  Narayana dental college and hospital 
Address  Department of periodontology Narayana dental college and hospital Room no 5 second floor chinta reddy palem Nellore
Department of periodontology Narayana dental college and hospital Room no 5 second floor chinta reddy palem Nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  9849798990  
Fax    
Email  perioramesh@yahoo.co.in  
 
Source of Monetary or Material Support  
Vellamaplli udhaya bhanu post graduate student narayana dental college and hospital chintareddy palem Nellore  
 
Primary Sponsor  
Name  vellampalli udhaya bhanu  
Address  3/496 lakshmipuram stone housepet nellore 524001 
Type of Sponsor  Other [self] 
 
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 
udhayabhanu  Department of periodontiology  Room no-5 second floor Department of periodontology chintareddy palem nellore
Nellore
ANDHRA PRADESH 		 8074685129

udayabhanuvelampalli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  chronic periodontitis ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Photo Dynamic Therapy  0.1% Toluidine blue with low laser application once  
Comparator Agent  Probiotic  1 mg Lactobacillus Reuteri subgingivally placed local delivery system once 
Intervention  Scaling  Ultrasonic scaling and Root planing once 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Age limit 25 to 60 years.
2)Patient with chronic periodontitis with a probing pocket depth ≥5 mm
3)Patients who are systemically healthy are included.
4)Atleast a minimum of 20 Permanent natural teeth should be present.
 
 
ExclusionCriteria 
Details  1)Patients with ongoing antibiotic therapy.
2)Pregnancy, lactating and smoking.
3)Patients undergone surgical or nonsurgical therapy with in 6months prior the study.
4)Patients who are deemed to be uncooperative.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome: RAL (Relative attachment level) gain.
secondary outcome variable will be PI, GI ,BOP and probing depth

To test the hypothesis of adjunctive probiotics and photo dynamic therapy being able to improve non surgical periodontal therapy.
 		 baseline , 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival index, Bleeding index, Plaque index  Baseline, 3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   12/05/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="3" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   study not yet completed 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

 The aim of the study was to evaluate the clinical and microbiological efficacy of probiotic bacteria with and without photodynamic therapy as an adjunct to scaling and root planning in patients with chronic periodontitis.

 The objective of the current study is to reduce the sub-gingival pathogenic microorganisms by local administration of beneficial bacteria subgingivally with and without photodynamic therapy concomitantly to phase-1 periodontal therapy.

A double masked, randomized controlled clinical trial will be conducted with a sample size of 100 between the age limit of 25-60 years will be selected from the outpatient unit of department of periodontology based on the following criteria.

All the patients will be explained about the aim, nature, and design of the study along with a written informed consent for their participation before the commencement of the study.

The clinical parameters for consideration includes plaque index (Silness and Loe 1964),  gingival index (Loe and silness 1963), modified sulcular gingival bleeding index (Mombelli,&oosten1987), pocket depth and clinical attachment level will be assessed at baseline. A thorough   SRP will be performed in all the patients. After SRP the subjects will be randomly allocated to group A,B,C,D based on computer generated randomized table.

TREATMENT PROCEDURE:

After SRP, PDT will be performed with diode laser in combination with photosensitizer dye.Periodontal pockets will be filled with the photosensitizer employing a blunt cannula starting from the bottom of the pocket to achieve both, complete filling of the pocket and coating of the root surface. After 3 minutes residence time, the pockets will be rinsed with water to remove excess photosensitizer. The remaining photosensitizer will be activated with the laser probe for 10 seconds. Probiotics will be inserted into periodontal pocket.

       CONTROL GROUP (A) : ONLY SRP

        TEST GROUP (B): SRP+PDT
        TEST GROUP (C): SRP+PROBIOTICS

         TEST   GROUP (D):SRP +PROBIOTICS +PDT.

The patients will be recalled after 3months for further evaluation of periodontal clinical parameters. In addition to evaluation of clinical parameters, periodontal pathogenic microbiological evaluation will be performed at both baseline and at 3months. The obtained data will be subjected to statistical analysis.                       


 
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