| CTRI Number |
CTRI/2026/01/100092 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two handpiece in surgical removal of wisdom tooth - a randomized control study |
|
Scientific Title of Study
|
Comparison of air-driven turbine handpiece vs conventional electric-driven handpiece in surgical removal of mandibular third molars- a randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kadambari Vivek Kakde |
| Designation |
Post graduate student |
| Affiliation |
Meenakshi Ammal Dental College, Alapakkam Main Road, Maduravoyal, Chennai |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
7083576747 |
| Fax |
|
| Email |
kakdekadambari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Devadoss |
| Designation |
Professor, Department of Oral and Maxillofacial Surgery |
| Affiliation |
Meenakshi Ammal Dental College, Alapakkam Main Road, Maduravoyal, Chennai |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9840722457 |
| Fax |
|
| Email |
dr_pradeepds@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kadambari Vivek Kakde |
| Designation |
Post graduate student |
| Affiliation |
Meenakshi Ammal Dental College, Alapakkam Main Road, Maduravoyal, Chennai |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
7083576747 |
| Fax |
|
| Email |
kakdekadambari@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kadambari Vivek Kakde |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai |
| 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 Kadambari Vivek Kakde |
Meenakshi Ammal Dental Collee and Hospital, Chennai |
Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Maduravoyal, Chennai
Chennai
TAMIL NADU |
07083576747
kakdekadambari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Meenakshi Ammal Dental College & Hospital, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bilaterally impacted third molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Surgical Exraction of impacted third molar using straight electric driven handpiece. |
Surgical Exraction of impacted third molar using straight electric driven handpiece with extraoral irrigation.
operative time is recorded.
then patient is recalled on post-op 1st, 3rd and 7th for assessment of outcome factors.
As this is a comparison of instrument and not a drug related intervention , dose, frequency, route of administration is not applicatble. |
| Comparator Agent |
Surgical Extraction of impacted third molar using angulated aerotor handpiece. |
Surgical Extraction of impacted third molar using angulated aerotor handpiece with in built irrigation.
operative time is recorded.
then patient is recalled on post-op 1st, 3rd and 7th for assessment of outcome factors.
As this is a comparison of instrument and not a drug related intervention , dose, frequency, route of administration is not applicatble. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients age 18 to 50 years.
b) Patients with bilateral Impacted Third Molars with similar Pederson Difficulty Index.
c) Healthy patients with no systemic co morbidities.
|
|
| ExclusionCriteria |
| Details |
a) Patients with systemic diseases.
b) Patients contraindicated for surgical removal of third molars.
c) Patients not willing to be a part of the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Operating time and post operative sequelae
(Pain, Swelling, Healing and Trismus). |
Outcomes will be assessed on Post-op day 0, 1, 3 and 7.
Except operative time which is assessed intraoperatively from incision to closure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Operating time. Post operative Pain, swelling, Moth opening, Pain score |
on Day 1, 3 & 5 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/01/2026 |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized controlled trial comparing the efficacy of a 45degree angled air-driven turbine handpiece with internal irrigation versus a conventional electricdriven straight handpiece with external irrigation in the surgical removal of mandibular third molars Patients aged 18 to 50 years with bilateral impacted mandibular third molars and similar difficulty Pederson Index will be included Using a split-mouth design each patient will have one side treated with each technique Outcomes measured include postoperative swelling pain using a visual analog scale trismus operating time and healing at several postoperative time points Statistical analysis will assess differences between the two techniques |