| CTRI Number |
CTRI/2022/01/039160 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Bacteria in Root Canal and External Root Surface |
|
Scientific Title of Study
|
Microbial Evaluation of Apical Periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinesh G |
| Designation |
MDS |
| Affiliation |
Thai Moogambigai Dental College |
| Address |
Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai 600107
Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai 600107
Chennai
TAMIL NADU
631402
India |
| Phone |
9176988804 |
| Fax |
|
| Email |
joodine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A R Pradeep Kumar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Thai Moogambigai Dental College |
| Address |
Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai 600107
Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai 600107
Chennai
TAMIL NADU
600031
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A R Pradeep Kumar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Thai Moogambigai Dental College |
| Address |
Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai 600107
Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai 600107
Chennai
TAMIL NADU
600031
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dinesh G |
| Address |
Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai 600107 |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Dinesh G |
Thai Moogambigal Dental College & Hospital |
Room no 202, Department of Conservative Dentistry & Endodontics
Chennai
TAMIL NADU |
9176988804
joodine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics review board Dr M.G.R educational research institute, university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Teeth requiring extraction |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Apical periodontitis / pulp necrosis
2. Age group - 40-60yrs
3. Non diabetic ≤6.5
4. PAI ≥3
5. Teeth indicated for extraction /unrestorable teeth
7. Patient not willing for RCT
|
|
| ExclusionCriteria |
| Details |
1. with periodontal discharge
2. presence of sinus
3. Antibiotic history for 3 months
4. Diabetes
5. Under medication –steroids
6. Root fracture, cracks
7. Resorption
8. Pocket depth > 3mm
9. RC treated teeth
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate bacterial presence between intra radicular and extra radicular biofilm |
single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate bacterial presence in extra radicular biofilm |
single time point |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate the intraradicular and
extraradicular biofilm in infected root canal system. 10 teeth
with
dental caries with apical periodontitis and PAI score greater than 3 indicated
for extraction
were selected in our study . First, patients were asked to
rinse
with
0.2% chlorhexidine
mouthwash and Local anaesthesia was administered. Teeth were extracted
and the apical 3 mm of the root apex was washed with
sterile saline to remove blood and planktonic bacteria and then resected
perpendicularly to the long axis of the tooth. A portion of periapical soft tissue/root
surface was scraped
using spoon excavator and placed
in a sterile Eppendorf tube containing 1mL DNA Buffer . The intra-radicular content is removed
using #15 and # 20 file and collected in a 1.5mL Eppendorf tube containing buffer . Microbial evaluation of samples was
done.
|