| CTRI Number |
CTRI/2025/05/086382 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare two tooth root removal methods in patients with broken tooth roots to see which one causes less pain, faster healing, better quality of life, smaller wound size, and takes less time |
|
Scientific Title of Study
|
Comparison of Luxator assisted vs conventional elevator-forceps technique for Root Stump Extraction: A Randomized Controlled 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 |
Dr Neeraj Bansal |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room no - QG43, Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9971338761 |
| Fax |
|
| Email |
doc.neerajbansal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Bansal |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room no - QG43, Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9971338761 |
| Fax |
|
| Email |
doc.neerajbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Bansal |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room no - QG43, Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9971338761 |
| Fax |
|
| Email |
doc.neerajbansal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manav Rachna Dental College |
| Address |
Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 |
| 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 Neeraj Bansal |
Manav Rachna Dental College |
Room no - QG43, Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana - 121004
Faridabad
HARYANA |
9971338761
doc.neerajbansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MRDC, SDS, MRIIRS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K083||Retained dental root, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Elevator-Forceps Tooth Root Stump Extraction |
Patients in this group will undergo standard root stump extraction using conventional elevator and forceps technique. The mucoperiosteal flap will be elevated, and the root will be removed using traditional method. Each patient will be followed up for at least 2 weeks to assess study objectives such as wound healing, post-operative pain, quality of life, wound diameter, and time taken for root stump removal. The total duration of the study, including recruitment and follow-ups, is expected to be 3 months. |
| Intervention |
Luxator-Assisted Tooth Root Stump Extraction |
Patients in this group will undergo root stump extraction using a luxator to sever the periodontal ligament and expand the socket. If required, forceps may be used to complete the extraction. Each patient will be followed up for at least 2 weeks to assess study objectives such as wound healing, post-operative pain, quality of life, wound diameter, and time taken for root stump removal. The total duration of the study, including recruitment and follow-ups, is expected to be 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient requiring non-complicated tooth root extraction.
Patients with no systemic conditions affecting healing.
Patients without active local infection at the extraction site.
|
|
| ExclusionCriteria |
| Details |
Patients with primary, malformed, dilacerated or third molar roots.
Cases requiring trans-alveolar extraction.
Patients requiring primary closure after extraction.
Patients with uncontrolled systemic comorbidities affecting healing.
Patients on anticoagulant therapy.
Patients with a history of tobacco/alcohol abuse.
Patients with active local infection at the extraction site.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healing |
Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound Diameter |
Day 0, Day 7 |
| Post-operative Pain |
Day 0, Day 3, Day 7 |
| Time Taken for Extraction |
Day 0 |
| Quality of Life |
Day 14 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/05/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 designed to compare the clinical outcomes of two techniques for tooth root stump extraction: the luxator-assisted technique versus the conventional elevator-forceps method. A total of 150 patients requiring extraction of non-complicated root stumps will be randomly assigned to one of the two groups. The intervention group (Group A) will undergo luxator-assisted extraction, while the control group (Group B) will receive the standard extraction method using elevator and forceps. The primary outcome will be wound healing, measured using the Landry Wound Healing Index on Day 7 post-extraction. Secondary outcomes will include post-operative pain (measured using the Visual Analog Scale (VAS) on Day 0, 3, and 7), wound diameter (measured with a flexible scale on Day 0 and 7), extraction time (measured with a stopwatch on Day 0), and the impact on quality of life (measured using the OHIP-14 questionnaire on Day 14). Both participants and outcome assessors will be blinded to the group assignments, ensuring objective evaluation of clinical outcomes. The study aims to determine if the luxator-assisted technique results in superior clinical outcomes in terms of healing, patient comfort, and procedural efficiency compared to the conventional extraction method. |