| CTRI Number |
CTRI/2025/11/097001 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in patients who needs wisdom tooth removal and to compare two tooth sectioning techniques and find which causes less surgery time and post operative swelling |
|
Scientific Title of Study
|
Removal Of Horizontally Impacted Mandibular Third Molars Using Two Different Tooth Sectioning Techniques- A Split Mouth Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Jayan K |
| Designation |
Assistant Professor |
| Affiliation |
Goverment Dental College Thrissur |
| Address |
Jai Vilas
Viyyur
Thrissur - 680010
Government Dental College
Thrissur Medical College
P.O Thrissur,Kerala-680596
Thrissur
KERALA
680010
India |
| Phone |
7907853056 |
| Fax |
|
| Email |
nidhikj002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Jayan K |
| Designation |
Assistant Professor |
| Affiliation |
Goverment Dental College Thrissur |
| Address |
Government Dental College
Thrissur Medical College
P.O Thrissur, Kerala - 680596
Jai Vilas
Viyyur
Thrissur - 680010
Thrissur
KERALA
680010
India |
| Phone |
7907853056 |
| Fax |
|
| Email |
nidhikj002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Jayan K |
| Designation |
Assistant Professor |
| Affiliation |
Goverment Dental College Thrissur |
| Address |
Government Dental College
Thrissur Medical College P.O, Thrissur,Kerala-680596
Jai Vilas
Viyyur
Thrissur-680010
Thrissur
KERALA
680010
India |
| Phone |
7907853056 |
| Fax |
|
| Email |
nidhikj002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Thrissur |
|
|
Primary Sponsor
|
| Name |
Government Dental College Thrissur |
| Address |
Government Dental College Thrissur
Parappuram Road
Peringandoor
Thrissur
Kerala
India-680596. |
| Type of Sponsor |
Government 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 |
| Nidhi Jayan K |
Government Dental College Thrissur |
Department Of Oral and Maxillofacial Surgery
Room NO 111
Government Dental College Thrissur
Medical College
P.O Thrissur
Kerala
India-680596
Thrissur
KERALA |
08547732214
nidhikj002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT DENTAL COLLEGE THRISSUR constituted as per order no :B/4178/2019/GDCTSR dated 27/05/2023 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients present with symptomatic mandibular third molar impactions |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 1- SECTIONING ALONG LONG AXIS |
In Group I sectioning of tooth along the long axis is done on
the right side in 15 patients and on the left side in 15 patients |
| Comparator Agent |
GROUP 11 -TRANSVERSE SECTIONING |
In group II transverse section of
tooth is done along the cementoenamel junction on the right side in 15 patients and on the left
side in 15 patients. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
A total of 30 patients with bilateral horizontally impacted mandibular third molars according
to Winters’s classification in orthopantomogram are included in this prospective study. Patients
with no medical comorbidities and in the age group of 20 - 40 years are selected for this study.
Before the surgical procedure, all patients will be informed in detail about the surgical
procedure, the average time required for the surgery, and possible intraoperative and
postoperative complications; all patients will be requested to sign an informed consent form
for inclusion in the study. Total 30 patients divided into two groups. Patients are randomly
selected for group I and group II. In Group I sectioning of tooth along the long axis is done on
the right side in 15 patients and on the left side in 15 patients. In group II transverse section of
tooth is done along the cementoenamel junction on the right side in 15 patients and on the left
side in 15 patients. |
|
| ExclusionCriteria |
| Details |
Medically compromised patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the duration of surgical procedure between two different
tooth sectioning techniques for the removal of the horizontally impacted mandibular
third molars |
At baseline assessment.Duration of surgical procedure evaluated on the day of surgery . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of two different tooth sectioning techniques on post operative
odema in patient undergoing the removal of horizontally impacted mandibular third
molars |
5th post operative day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/11/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - NO
|
Brief Summary
Modification(s)
|
This randomized clinical trial compares two different tooth sectioning techniques for removal of horizontally impacted mandibular third molars. The aim is to evaluate duration of surgical procedure and post operative odema on the 5th post operative day. Outcomes will help determine a more efficient and less traumatic technique for third molar surgery. I have started recruiting patients.will be completed soon |