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
|
|
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
|
|
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. |