| CTRI Number |
CTRI/2025/03/082652 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of traditional radiographic indices with volume-based index based on cone beam computed tomography in teeth with apical periodontitis |
|
Scientific Title of Study
|
Assessment of correlation between Cone beam computed tomography-Periapical Volume Index and
traditional radiographic indices in endodontic lesion evaluation : A
volumetric analysis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma Rajasekhar |
| Designation |
PhD scholar |
| Affiliation |
|
| Address |
Room number 6
Department of conservative dentistry and endodontics
MES dental college,
Malaparamba,Palachode P.O,
Kolathur,Perinthalmanna
Malappuram
Malappuram
KERALA
679321
India |
| Phone |
8606008164 |
| Fax |
|
| Email |
reshmarajasekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kailash attur |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of conservative dentistry and endodontics,
Narasinhbhai patel dental college,
Gandhinagar link road,
Visnagar,Gujarat
Gandhinagar
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reshma Rajasekhar |
| Designation |
PhD scholar |
| Affiliation |
|
| Address |
Room number 6
Department of conservative dentistry and endodontics
MES dental college,
Malaparamba,Palachode P.O,
Kolathur,Perinthalmanna
Malappuram
Malappuram
KERALA
679321
India |
| Phone |
8606008164 |
| Fax |
|
| Email |
reshmarajasekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry,
MES dental college ,
Malapparamba,Palachode p.o
Perinthalmanna,Malappuram
Kerala |
|
|
Primary Sponsor
|
| Name |
Dr.Reshma Rajasekhar |
| Address |
MES dental college , Malapparamba,Palachode p.o Perinthalmanna,Malappuram Kerala |
| 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 |
| Reshma Rajasekhar |
MES dental college |
Room number 6,
Department of conservative dentistry and endodontics,
MES dental college,
Malaparamba,Palachode P.O,
Kolathur,Perinthalmanna
Malappuram
Malappuram
KERALA |
8606008164
reshmarajasekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NPDCH Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apical periodontitis,Dental caries |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Single rooted teeth with diagnosis of pulp necrosis and radiographic signs of periapical lesion.
Patients of age group 15 years to 65 years.
Teeth with deep caries, crown fracture ,history of trauma ,discolouration.
Teeth with associated gingival swelling ,draining sinus tract
Teeth with absence or delayed response to electric pulp testing and cold testing .
Endodontically treated / previously initated treatment with radiographically visible apical
periodontitis. |
|
| ExclusionCriteria |
| Details |
Multirooted teeth
Large periapical lesion joining the apex of more than 1 teeth
Teeth with periodontal abscess and positive response to sensibility tests |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Correlationship between Periapical index and CBCTPAVI,Association/relationship between Complex periapical index & CBCTPAVI,Correlationship between Endodontic radiolucency Index & CBCTPAVI |
Outcome assessed after 8 months based on the data collected from patients coming to the outpatient department. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Correlationship between indices based on gender of the patient |
Outcome assessed after 8 months based on the data collected from patients coming to the outpatient department. |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
25/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
220 single rooted teeth will be selected from patients based on inclusion criteria.Teeth will be subjected to sensibility tests using electric pulp tester and endofrost followed by radiographic imaging using periapical radiographs and CBCT. Orstavik’s periapical index scores were recorded from periapical radiographic images whereas endodontic radiolucency index,complex periapical index were recorded from CBCT scans of the patient. CBCT periapical volume will be calculated using ITK SNAP (4.0) software using manual and semi automatic segmentation as well as using MONAI deep learning software. After recording the index scores the Orstavik’s periapical index , Endodontic radiolucency index (ERI), Complex periapical index (COPI) of PESS index are correlated with CBCT periapical volume index |