| CTRI Number |
CTRI/2025/09/095393 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
fficacy of Mineral Trioxide Aggregate Pulpotomy as an Adjunct to Coronectomy in High-Risk Mandibular Third Molar Impactions |
|
Scientific Title of Study
|
Efficacy of Mineral Trioxide Aggregate (MTA) Pulpotomy as an Adjunct to Coronectomy in High-Risk Mandibular Third Molar Impactions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay Yadav |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences (AIIMS) |
| Address |
Room no AY 122, ground floor, AYUSH Building, All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Room no 4, ground floor, AYUSH Building,All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Nalgonda
TELANGANA
508126
India |
| Phone |
8130319992 |
| Fax |
|
| Email |
drvjyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Negi |
| Designation |
professor and head, department of dentistry , AIIMS bibinagar |
| Affiliation |
All India Institute Of Medical Sciences (AIIMS) |
| Address |
Room no AY 122, ground floor, AYUSH Building, All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Room no 4, ground floor, AYUSH Building,All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Hyderabad
TELANGANA
508126
India |
| Phone |
9868604172 |
| Fax |
|
| Email |
dranurag.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Yadav |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences (AIIMS) |
| Address |
Room no AY 122, ground floor, AYUSH Building, All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Room no 4, ground floor, AYUSH Building,All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
TELANGANA
508126
India |
| Phone |
8130319992 |
| Fax |
|
| Email |
drvjyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences Bibinagar
Bibinagar Yadadri Bhuvanagiri District hyderabad
Telangana Pin 508126
India |
| 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 |
| Dr Vijay Yadav |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, bibinagar, hyderabad |
Room no AY 122, ground floor, AYUSH Building, All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Nalgonda
TELANGANA |
8130319992
drvjyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences BIBINAGAR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparators:
Group B - (Coronectomy only) – Active control AND
Group C: Complete surgical extraction ( Standard treatment control) |
Group B – Coronectomy Only
Standard coronectomy under local anesthesia, with crown removal and root stump reduction to 3–4 mm below alveolar crest level.
No adjunctive pulpal therapy is applied.
Flap closure with 3-0 Vicryl sutures.
Group C – Complete Surgical Extraction (Standard Comparator)
Conventional surgical extraction of the impacted mandibular third molar under local anesthesia.
Includes patients who insist on extraction of impacted mandibular third molars even after being informed of the potential risk of inferior alveolar nerve injury.
Complete removal of crown and roots, socket irrigation, and flap closure with 3-0 Vicryl sutures. |
| Intervention |
Group A -
Coronectomy with MTA Pulpotomy
|
Group A – Coronectomy without MTA Pulpotomy
A standard coronectomy will be performed under local anesthesia. The crown will be sectioned and removed, with the root stump reduced 3–4 mm below the alveolar crest.
Mineral Trioxide Aggregate will then be placed over the exposed pulp chamber to maintain vitality and prevent infection.
Flap closure will be achieved with 3-0 Vicryl sutures.
Flap closure will be achieved with 3-0 Vicryl sutures.
Common to All Groups:
Preoperative mouth rinse with 0.2% chlorhexidine gluconate.
Local anesthesia with 2 percent lignocaine with 1:200,000 epinephrine.
Standard postoperative regimen: Amoxicillin 500 mg TID for 5 days, Ibuprofen 400 mg BID for 3 days, and 0.2% chlorhexidine mouthwash TID for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 to 50 years, classified as ASA I according to the American Society of Anesthesiologists classification, with indications for extraction of impacted mandibular third molars due to dental caries, caries in adjoining mandibular second molar or history of recurrent pericoronitis or periodontal disease.
2. Radiographic markers on panoramic X-rays: Radiographic assessment revealed one or more high-risk indicators as defined by Rood and Shehab, including increased radiolucency at the root apex, root narrowing, or disruption of the radiopaque border of the inferior alveolar nerve canal (IANC), indicating close proximity to the inferior alveolar nerve.
3. Cone-Beam Computed Tomography (CBCT) confirmation demonstrated direct contact between the root and the mandibular canal, with the absence of intervening cortical bone.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Patients with systemic conditions (uncontrolled diabetes, bleeding disorders etc ) , history of radiotherapy contraindicating surgical procedures.
2. Infection or periapical pathology involving the Impacted third molar region.
3. Pre-existing IAN injury or neurological deficits.
4. Non-vital teeth, caries extending to the root, periapical infection and immature root apex.
5. Mobility of root during coronectomy.
6. Patients not willing to provide informed consent.
7. Patients with a history of tobacco use in any form, including smoking and smokeless tobacco (e.g., pan, gutka).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcomes:
1. Postoperative Pain: Measured using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours, comparing pain reduction and total analgesic consumption between the MTA pulpotomy and coronectomy groups.
2. Postoperative Swelling: Assessed using facial measurements on Days 1, 3, and 7 post-surgery. Quantified using facial measurements (tragus-commissure and tragus-pogonion distance), comparing preoperative and postoperative values.
3. Inferior Alveolar Nerve (IAN) Injury: Assessed clinically for signs of paresthesia or dysesthesia in the area of the IAN/ mental nerve distibution, evaluated during follow-up visits day 1 and at 1 week using von frey monofilament fibres.
|
Primary Outcomes:
1. Postoperative Pain: Measured using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours, comparing pain reduction and total analgesic consumption between the MTA pulpotomy and coronectomy groups.
2. Postoperative Swelling: Assessed using facial measurements on Days 1, 3, and 7 post-surgery. Quantified using facial measurements (tragus-commissure and tragus-pogonion distance), comparing preoperative and postoperative values.
3. Inferior Alveolar Nerve (IAN) Injury: Assessed clinically for signs of paresthesia or dysesthesia in the area of the IAN/ mental nerve distibution, evaluated during follow-up visits day 1 using von frey monofilament fibres. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Healing and Infection: Assess secondary intention healing and the incidence of postoperative infection (pus).
2. Post-operative Root Migration: Changes in the position of the retained root relative to anatomical landmarks on follow-up radiographs (OPG or CBCT) at 3, 6, and 12 months.
3. Patient-Reported Satisfaction and Quality of Life: Assessed using a custom 5-point Likert scale for satisfaction, ease of recovery, and willingness to undergo the procedure again if needed
|
Healing and infection- 1 Week 3 week
Postoperative root migration- 3, 6 and 12 months
Patient reported satisfaction and quality of life - 1 week postoperatively |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
02/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The extraction of impacted mandibular third molars is a common oral surgical procedure, but deeply impacted teeth in close proximity to the inferior alveolar nerve (IAN) carry a significant risk of nerve injury, which may result in paresthesia, dysesthesia, or anesthesia. Coronectomy, a nerve-sparing alternative to complete extraction, reduces the risk of IAN injury but is associated with complications such as root migration and postoperative infection. Mineral Trioxide Aggregate (MTA) pulpotomy is a vital pulp therapy technique with proven biocompatibility and regenerative potential. Its application to retained roots after coronectomy may help seal the pulp chamber, minimize bacterial contamination, reduce infection risk, and stabilize the remaining root structure. This randomized controlled trial will evaluate the efficacy of MTA pulpotomy as an adjunct to coronectomy compared with coronectomy alone and complete extraction. A total of 54 patients with high-risk mandibular third molars, identified radiographically by Rood and Shehab’s criteria, will be randomly allocated into three groups: Group A (Coronectomy + MTA pulpotomy), Group B (Coronectomy only), and Group C (Complete extraction - Includes patients who insist on extraction of impacted mandibular third molars even after being informed of the potential risk of inferior alveolar nerve injury.) The primary outcomes will include postoperative pain, swelling, and IAN injury. Secondary outcomes will assess healing, infection, root migration, and patient-reported satisfaction and quality of life. The study is expected to provide evidence for improved management strategies in high-risk third molar impactions, with the aim of reducing postoperative morbidity while preserving IAN integrity. |