| CTRI Number |
CTRI/2024/11/076742 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of position and dimension of posterior superior alveolar canal located in the wall of the upper jaw in relation to the adjacent anatomical structures |
|
Scientific Title of Study
|
Assessment of position and dimension of posterior superior alveolar canal in relation to the alveolar crest and floor of the maxillary sinus: a retrospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1315-2826 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meru S |
| Designation |
Professor and Head dept of Oral Medicine andRadiology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 1, Dept of Oral Medicine and Radiology,
Uttaranchal Dental and Medical Research Institute,
Majri grant, Haridwar road, Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8126192404 |
| Fax |
|
| Email |
drmeru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meru S |
| Designation |
Professor and Head dept of Oral Medicine andRadiology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 1, Dept of Oral Medicine and Radiology,
Uttaranchal Dental and Medical Research Institute,
Majri grant, Haridwar road, Dehradun
UTTARANCHAL
248140
India |
| Phone |
8126192404 |
| Fax |
|
| Email |
drmeru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meru S |
| Designation |
Professor and Head dept of Oral Medicine andRadiology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 1, Dept of Oral Medicine and Radiology,
Uttaranchal Dental and Medical Research Institute,
Majri grant, Haridwar road, Dehradun
UTTARANCHAL
248140
India |
| Phone |
8126192404 |
| Fax |
|
| Email |
drmeru@gmail.com |
|
|
Source of Monetary or Material Support
|
| CBCT Reporting Center, Dept of Oral Medicine and Radiology,
Uttaranchal Dental and Medical Research Institute,
Majri grant, Haridwar road, Dehradun |
|
|
Primary Sponsor
|
| Name |
Uttaranchal Dental and Medical Research Institute |
| Address |
Uttaranchal Dental and Medical Research Institute,
Majri grant, Haridwar road, Dehradun |
| Type of Sponsor |
Other [Private dental 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 Meru S |
Uttaranchal Dental Medical Research Institute |
room no 1 dept of Oral medicine and radiology. Majri grant Dehradun
Dehradun
UTTARANCHAL |
8126192404
drmeru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Uttaranchal Dental and Medical Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
CBCT images of maxilla taken for diagnostic and treatment planning purpose in patients with any indication for imaging.
Good quality images.
|
|
| ExclusionCriteria |
| Details |
CBCT images with metal artefacts in the area of interest.
Images not showing the maxillary sinus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Location of the canal in relation lateral wall of the sinus.
Distance from lower edge of canal to sinus floor at anterior extent.
Distance from lower edge of canal to sinus floor at posterior extent.
Distance from lower edge of canal to crestal bone at anterior region.
Distance from lower edge of canal to crestal bone at posterior region
|
one time after the CBCT images are selected for inclusion into the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Distance from lateral edge of canal to mesial wall at anterior end
Distance from lateral edge of canal to mesial wall at posterior end
Distance from lower edge of canal to longest buccal root apex of first molar
Distance from lower edge of canal to longest root apex of second molar
|
one time after the CBCT images are selected for inclusion into the study |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
02/12/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmeru@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 30-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Background:Familiarity with the anatomy of the arteries in the sinus wall is essential to prevent the perforation of the sinus membrane and bleeding during dental implant surgery. PSAA should be analyzed during planning sinus lifting with lateral approach. Objectives. The aim of the study is to evaluate the anatomical position of the posterior superior alveolar artery (PSAA), using cone-beam computed tomography (CBCT).
Methods: A total of 200 CBCT scans that mete the eligibility criteria for this cross-sectional study will be selected.. The vertical distance from the lower border of the artery to the lower border of the sinus floor, the diameter of the artery, and the type of artery (intrasinusoidal, intraosseous or superficial) in the first and second premolar and molar regions will be measured.
The data was analyzed with the t tests, the one-way analysis of variance (ANOVA) and the χ2 tests. |