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CTRI Number  CTRI/2022/01/039684 [Registered on: 25/01/2022] Trial Registered Prospectively
Last Modified On: 13/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   root canal treatment and periodontium. 
Scientific Title of Study   Effect of endodontic treatment on periodontal healing of endo-periodontal lesions-A randomised clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swet Nisha 
Designation  Assistant professor 
Affiliation  Haldia Institute Of Dental Sciences and Research 
Address  Haldia Institute of Dental Sciences and Research,Division Of Dentistry,Department Of Periodontology

Medinipur
WEST BENGAL
721645
India 
Phone  07595800724  
Fax    
Email  swetnisha1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Swet Nisha 
Designation  Assistant professor 
Affiliation  Haldia Institute Of Dental Sciences and Research 
Address  Haldia Institute of Dental Sciences and Research,Division Of Dentistry,Department Of Periodontology

Medinipur
WEST BENGAL
721645
India 
Phone  07595800724  
Fax    
Email  swetnisha1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swet Nisha 
Designation  Assistant professor 
Affiliation  Haldia Institute Of Dental Sciences and Research 
Address  Haldia Institute of Dental Sciences and Research,Division Of Dentistry,Department Of Periodontology

Medinipur
WEST BENGAL
721645
India 
Phone  07595800724  
Fax    
Email  swetnisha1@gmail.com  
 
Source of Monetary or Material Support  
Haldia Institute of dental sciences and research  
 
Primary Sponsor  
Name  Swet Nisha 
Address  Haldia Institute of dental sciences and research,Haldia 
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 
Swet Nisha  Haldia Institute of dental sciences and research  Haldia Institute of dental sciences and research,Division-Dentistry,Department of Periodontology Medinipur WEST BENGAL
Medinipur
WEST BENGAL 
9883916227

swetnisha1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Haldia institute of dental sciences and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  root canal treatment alone and in combination with periodontal regenerative therapy.  comparison of 2 treatment plan for endo-periodontal lesions without root damage. Follow up will be done at baseline,3,6 and 12 months  
Intervention  root canal treatment and periodontal regenerative surgery  Group A - will receive root canal treatment followed by periodontal regenerative surgery.papilla preservation flap will be performed in indicated cases. Group B - will receive root canal treatment only. Follow up will be done baseline,3,6 and 12 months .  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  subjects diagnosed with endoperio lesions without root damage in non periodontitis patients 
 
ExclusionCriteria 
Details  subjects who had undergone any periodontal treatment in past 12 months.
subjects on anti-inflammatory / antimicrobial therapy in past 6 months.
subjects with any systemic diseases.
unrestorable tooth,root resorption or grade 3 mobility
smokers
pregnant /lactating mother 
 
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 
change of pocket probing depth  baseline ,3 months and 6 months,9 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
change of PAI (periodontal apical index) ,bleeding on probing,plaque index
attachment loss  
baseline,3 months and 6 months,9 months and 12 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/01/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a randomised clinical trial comprising of two groups :Group 1 - will receive endodontic treatment followed by periodontal regenerative flap surgery. Group 2- will receive endodontic treatment only.
probing pocket depth ,clinical attachment level, bleeding on probing, periapical index will be evaluated to see effect of endodontic treatment on periodontal healing with and without periodontal regenerative flap surgery in endo-periodontal lesions without root damage.
 
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