| CTRI Number |
CTRI/2017/11/010405 [Registered on: 07/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Lingual foramen on CBCT |
|
Scientific Title of Study
|
Evaluation of Location and dimensions of mandibular lingual foramen using CBCT – A Retrospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalu Rai |
| Designation |
Principal Professor and Head of the department |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Oral Medicine and Radiology
Institute of Dental Studies and Technologies
Kadrabad
Modinagar
Uttar Pradesh
India
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9999448961 |
| Fax |
|
| Email |
drshalurai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPurwa Gangwal |
| Designation |
PG student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Oral Medicine and Radiology
Institute of Dental Studies and Technologies
Kadrabad
Modinagar
Uttar Pradesh
India
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
08630201706 |
| Fax |
|
| Email |
purwagangwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepankar Misra |
| Designation |
Reader |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Oral Medicine and Radiology
Institute of Dental Studies and Technologies
Kadrabad
Modinagar
Uttar Pradesh
India
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8285021920 |
| Fax |
|
| Email |
deepankarmisra@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Private imaging centre |
| Address |
Dental diagnostic centre, C-1, sector 23, Noida |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrShalu Rai |
Institute of dental studies and technologies |
Room no 1, Department of Oral medicine and technologies.kadrabad
Ghaziabad
UTTAR PRADESH |
9999448961
drshalurai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Institute of Dental Studies and Technologies, Kadrabad, Modinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CBCT indicated for implant purpose, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Age between 12-80 years
2 Absence of any pathological lesions in the anterior mandible.
3 Good quality of the CBCT mandibular scans at 5x5 and 5x8 will be taken for various purposes.
4 Absence of the severe atrophy of the lower jaw.
5 Absence of impacted teeth in the mandible.
6 Absence of any kind of h/o systemic diseases.
|
|
| ExclusionCriteria |
| Details |
1 Patients who refuse to give consent to share their CBCT scans
2 Mandibles with large pathologic lesions, bone fractures or deeply impacted teeth
3 Inadequate picture quality (artifacts caused by metallic implants or osteosynthesis plates; low resolution; patient movement during imaging).
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Location of the lingual foramen
2) Type of lingual foramen
3) Diameter/width at three levels i.e. at the lingual cortex, at the buccal cortex and at the middle of the canal
|
01/06 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
4) Vertical distance from the lingual foramina to alveolar crest
5) Vertical distance from the lingual foramina to lower border of mandible
6) Length/depth of the lingual canal
|
01/06/2018 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/06/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet submitted |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
- This is a retrospective observational randomized study, using 500 CBCT scan including subjects aged between 12 to 80 years will be included. Patients consent will be obtained for performing CBCT scans & to be used for Research purpose. Mandible should be free of any pathological lesions in the anterior mandible. Good quality of the CBCT mandibular scans at 5x5 and 5x8 will be taken for various purposes. Absence of the severe atrophy of the lower jaw. Patients who refuse to give consent to share their CBCT scans will not be included in the study. Mandibles with large pathologic lesions, bone fractures or deeply impacted teeth Inadequate picture quality (artifacts caused by metallic implants or osteosynthesis plates; low resolution; patient movement during imaging) will also not be included. - Aim of the study is to determine the location and other morphometric features of lingual foramina on CBCT in dentulous and edentulous patients, along with its age wise and gender wise correlation. And to provide a baseline information about anterior mandible for implant placement planning.
|