| CTRI Number |
CTRI/2021/04/032997 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
20/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Clinical And Radiological Evaluations Of Irregularly Placed Mandibular Wisdom Tooth After Removing The Upper Tooth Structure And Leaving The Root In The Socket |
|
Scientific Title of Study
|
Clinical And Radiological Evaluations Of Coronectomy For Impacted Madibular Third Molars - An In-vivo 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 Joon Sunil |
| Designation |
Postgraduate Student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Department Of Oral And Maxillofacial Surgery Room No 2 Coorg Institute Of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet
Kodagu
KARNATAKA
571218
India |
| Phone |
9591349950 |
| Fax |
|
| Email |
joonsunil041@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joon Sunil |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
coorg institute of dental sciences |
| Address |
Department Of Oral And Maxillofacial Surgery Room No 2 Coorg Institute Of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet
Kodagu
KARNATAKA
571218
India |
| Phone |
9591349950 |
| Fax |
|
| Email |
joonsunil041@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S vinod thangaswamy |
| Designation |
professor |
| Affiliation |
coorg institute of dental sciences |
| Address |
Department Of Oral And Maxillofacial Surgery Room No 2 Coorg Institute Of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet
Kodagu
KARNATAKA
571218
India |
| Phone |
9791642614 |
| Fax |
|
| Email |
svinodthangaswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Oral And Maxillofacial Surgery Room No 2 Coorg Institute Of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet |
|
|
Primary Sponsor
|
| Name |
Dr Joon Sunil |
| Address |
Department Of Oral And Maxillofacial Surgery Room No 2 Coorg Institute Of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet |
| 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 |
| DrJoon Sunil |
Coorg Institute of Dental Sciences |
Department Of Oral And Maxillofacial Surgery Room No 2 Coorg Institute Of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet Karnataka 571218 India
Kodagu
KARNATAKA |
9591349950
joonsunil041@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impacted third molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
coronectomy |
coronectomy for the tooth which is more close to the nerve to prevent paraesthesia of the inferior alveolar nerve |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
patient who is having impacted third molar
patient who had high risk of inferior alveolar nerve injury as revealed by the radiography(CBCT) specifically displacement of inferior alveolar canal by the roots
narrowing of third molar roots
narrowing of the canal
periapical radiolucent area
Darkening of the third molar roots
interruption and loss of lamina dura of nerve canal |
|
| ExclusionCriteria |
| Details |
medically compromised conditions such as diabetes chemotherapy previous radiotherapy and immunological diseases
patient with any plan for orthognathic surgery
teeth associated with apical pathology
teeth that are mobile should be excluded
patient who are pregnant
patient who is younger than sixteen years old due to premature root |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain Complete healing of the socket and reduction in bleeding where coronectomy is done |
Parameters are checked at 1st day 7th day and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gradual reduction in pain Complete healing of the socket and reduction in bleeding where coronectomy is done |
Parameters are checked at 1st day 7th day and 6th month |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
23/04/2021 |
| 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)
|
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)?
Response - NO
|
|
Brief Summary
|
Coronectomy is advocated as a method to manage the third molar that poses a risk of the injury to the inferior alveolar nerve and it seems to eliminate the risk . However the most appropriate application of the technique in the management of these teeth still remains un clear . The purpose is to cause minimal and the least amount of trauma to the tooth and patient with overall reduction in the post operative complications and increased long term success. Coronectomy is a conservative oral surgical procedure.
|