| CTRI Number |
CTRI/2025/01/079048 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Periapical pathology association with mucosal thickening |
|
Scientific Title of Study
|
Assessment Of Maxillary Posterior Teeth Pathologies And Its Association with maxillary Sinus Alterations- A Cone Beam Computed Tomographic Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K B A Kader |
| Designation |
Resident Post Graduate |
| Affiliation |
Institute Of Dental Sciences, Bareilly |
| Address |
manokamna mandir, suresh sharma nagar, bareilly, Uttar pardesh
manokamna mandir, suresh sharma nagar, bareilly, Uttar pardesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9679380416 |
| Fax |
|
| Email |
kbakaderdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Aggarwal |
| Designation |
Professor and head of department |
| Affiliation |
Institute Of Dental Sciences, Bareilly |
| Address |
16, Dept. of Oral Medicine & radiology, Institute Of dental science Bareilly, bareilly
16, Dept. of Oral Medicine & radiology, Institute Of dental science Bareilly, bareilly
UTTAR PRADESH
243006
India |
| Phone |
9358353566 |
| Fax |
|
| Email |
drashishagg01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Aggarwal |
| Designation |
Professor and head of department |
| Affiliation |
Institute Of Dental Sciences, Bareilly |
| Address |
16, Oral Medicine & Radiology, Institute of Dental Science bareilly, Bareilly
16, Oral Medicine & Radiology, Institute of Dental Science bareilly, Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9358353566 |
| Fax |
|
| Email |
drashishagg01@gmail.com |
|
|
Source of Monetary or Material Support
|
| institute of dental science, bareilly,Bareilly, Uttar Pardesh, 243006 |
|
|
Primary Sponsor
|
| Name |
K B A Kader |
| Address |
Institute Of Dental Science, Bareilly |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr K B A Kader |
Institute Of Dental Sciences, Bareilly |
16,Dept of Oral Medicine and Radiology, Institute Of Dental Science, Bareilly
Bareilly
UTTAR PRADESH |
9679380416
kbakaderdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IDS, Bareilly, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M272||Inflammatory conditions of jaws, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Maxillary CBCT scans showing all first and second premolars and first and second
molars, all fully erupted and with fully formed roots with periapical lesions |
|
| ExclusionCriteria |
| Details |
Patients with traumatic injuries and sinuses associated with implants and/or
augmentation.
Scans that did not allow for complete visualization of the maxillary sinus in the coronal
and axial views. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the association between maxillary posterior teeth periapical pathologies
and maxillary sinus mucosal changes using CBCT. |
1 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the association & corelate the maxillary posterior teeth periapical
pathologies & the maxillary sinus mucosal alterations using CBCT |
1 weeks |
|
|
Target Sample Size
|
Total Sample Size="151"
Sample Size from India="151"
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)
|
30/01/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kbakaderdoc@gmail.com].
- For how long will this data be available start date provided 11-11-2024 and end date provided 11-01-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Among the most common manifestations of maxillary sinus is Maxillary Sinusitis.
Since the maxillary posterior teeth’s roots are so close to the sinus floor, an infection might
spread there and thicken the sinus mucosa.However, in cases where the tooth roots are too near the sinus floor, odontogenic
infections may flow into the sinus. When diagnosing MS anomalies and periapical alterations,
radiographs are crucial diagnostic tools.Since computed tomographic (CT) imaging can produce images in thin CT slices and
many planes and can show bone and soft tissue, it is the standard imaging test for multiple
sclerosis.Consequently, CBCT with advantage of lower radiation dose and better spatial
resolution could be useful in identifying odontogenic maxillary sinusitis.Therefore, the purpose of this study is to evaluate the association between maxillary
posterior teeth periapical pathologies and maxillary sinus mucosal changes using CBCT |