| CTRI Number |
CTRI/2019/09/021300 [Registered on: 18/09/2019] Trial Registered Prospectively |
| Last Modified On: |
05/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
It is a study to observe X ray film that shows that the lower wisdom tooth is close to the underlying nerve is enough to suggest a CBCT Scan |
|
Scientific Title of Study
|
Accuracy Of Intraoral Periapical Radiographic Signs In The Assessment Of Relationship Between Impacted Mandibular Third Molar and Mandibular Canal For The Indication Of Cone Beam Computed Tomography And Determination Of Tooth Proximity To The Lingual Cortical Plate |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srujana Daniella Remulla |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College, Bhimavaram |
| Address |
Room no. 1,
Department of Oral Medicine and Radiology,
Vishnu Dental College , Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7702987931 |
| Fax |
08816250894 |
| Email |
srujanadaniella@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Jyothirmai |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College, Bhimavaram |
| Address |
Room no. 1,
Department of Oral Medicine and Radiology,
Vishnu Dental College , Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9866432477 |
| Fax |
08816250894 |
| Email |
jyothirmaik2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Jyothirmai |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College, Bhimavaram |
| Address |
Room no. 1,
Department of Oral Medicine and Radiology,
Vishnu Dental College , Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9866432477 |
| Fax |
08816250894 |
| Email |
jyothirmaik2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu dental college,
Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH 534202
India |
|
|
Primary Sponsor
|
| Name |
Vishnu Dental College |
| Address |
Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH 534202
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Srujana Daniella Remulla |
Vishnu Dental College |
Room no. 1,
Department of Oral Medicine and Radiology,
Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH |
7702987931
08816250894
srujanadaniella@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VISHNU INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra Oral Periapical Radiograph |
CARESTREAM DENTAL E- speed X ray films of size 2
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of the age group 18 years and above
2. Patients with Impacted Mandibular third molar
3. IOPA with any one of the signs of Rood’s and
Shehab Criteria |
|
| ExclusionCriteria |
| Details |
1. Patients not willing for CBCT
2. IOPA not showing Rood’s criteria
3. Patients below 18 years of age
4. Cyst and tumor associated third molar |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Accuracy of signs in relation to Mandibular Third Molar with the Inferior
Alveolar Canal
2. The proximity of Impacted Mandibular Third Molar to the Lingual Cortical
Plate
|
1. Accuracy of signs in relation to Mandibular Third Molar with the Inferior
Alveolar Canal - Day 0
2. The proximity of Impacted Mandibular Third Molar to the Lingual Cortical
Plate - Day 0
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Shape and Position of the Mandibular canal with respect to the
apices of the impacted third molar roots |
1. Shape and Position of the Mandibular canal with respect to the
apices of the impacted third molar roots - Day 0 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/09/2019 |
| 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="2"
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)?
|
|
Brief Summary
|
The study is a Descriptive Study to observe the accuracy of Intra Oral Periapical Radiographic [IOPAR] signs correlating with Cone Beam Computed Tomography[CBCT] in order to establish indication criteria for CBCT regarding the relation of Impacted Mandibular Third Molar to the Mandibular Canal. This study will be conducted at Vishnu Dental College, Bhimavaram. The primary outcome will be to determine the accuracy of IOPAR according to Roods and Shehab Criteria |