| CTRI Number |
CTRI/2025/12/099478 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Do Different Root Canal Sealers Affect Pain Relief and Healing After Treatment? |
|
Scientific Title of Study
|
Comparative analysis of post operative pain and healing of periapical lesion using different sealers after non surgical endodontic treatment. 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 Prashanth S |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital,Nagpur |
| Address |
117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR 117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR Nagpur MAHARASHTRA 400003 India |
| Phone |
9342522537 |
| Fax |
|
| Email |
sankardrprashant@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sadhana Raina |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital,Nagpur |
| Address |
117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR 117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR Nagpur MAHARASHTRA 400003 India |
| Phone |
9423685967 |
| Fax |
|
| Email |
drsadhanaraina@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sadhana Raina |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital,Nagpur |
| Address |
117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR 117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR Nagpur MAHARASHTRA 400003 India |
| Phone |
9423685967 |
| Fax |
|
| Email |
drsadhanaraina@gmail.com |
|
|
Source of Monetary or Material Support
|
| 117, Department of Conservative Dentistry and endodontics, Government dental college and hospital,Nagpur, Maharashtra 440003 ,India |
|
|
Primary Sponsor
|
| Name |
DR PRASHANTH S |
| Address |
DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
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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 |
| PRASHANTH S |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, NAGPUR |
117,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR Nagpur MAHARASHTRA |
9342522537
sankardrprashanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,government dental college and hospital,nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ENDOFILL |
PD Endofill (also referred to simply as Endofill) is a well-known radiopaque, zinc oxide-eugenol based root canal sealer containing dexamethasone for permanent obturation after a pulpectomy. The addition of dexamethasone provides anti-inflammatory properties to help reduce post-operative pain and sensitivity.
|
| Intervention |
MTA FILLAPEX |
MTA Fillapex is an endodontic sealer, while MTA Reparative is indicated for the treatment of perforations, root resorption, apical plug and pulp capping. |
| Comparator Agent |
ZINC OXIDE EUGENOL |
Zinc oxide eugenol (ZOE) is a widely used material in dentistry, primarily as a root canal (RC) sealer, temporary cement, or cavity liner. It is a powder/liquid system that reacts to form an amorphous chelate of zinc eugenolate.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. HEALTHY PATIENTS BETWEEN 18-60 YEARS
2. PAI SCORE 2 OR MORE |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| This randomised control clinical study is designed to analyse and compare the mentioned sealers in terms of their role in post-operative pain and peri-apical healing potential.To check in reduction of Post-operative pain intensity |
3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic healing of periapical lesion |
24 hours,48 hours & 7 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Post-operative pain has a multi-factorial aetiology and a potential pathogenic link to the acute inflammation of the periapical area, secondary to localized chemical, mechanical, host and/or microbial damage occurring during endodontic treatment. Postoperative pain is a usual and unpredictable outcome of endodontic treatment. Postoperative pain after RCT has been reported from 1.9%- 48%. Apical extrusion of debris (AED) or excessive apical region preparation are typically the causes of post-operative pain associated with RCT.Incomplete pulp removal, apical extrusion of the obturating material, chemical irritation, root fracture, and incorrect filling adjustment are other reasons for postoperative pain. Traditionally, gutta-percha combined with an endodontic sealer is used to fill root canal systems that need to be treated. Although these sealers are intended to be used inside the root canal during endodontic therapy, they may leach, lateral canal, or get into close contact with the periapical tissues.Sealers placed in the root canal may interfere with periodontal tissues through the apical foramen, lateral canals and can possibly affect the healing process in the periodontium. The severity of inflammatory reactions is influenced by a variety of factors including the root canal sealers composition. In addition to this,root canal sealer might activate the trigeminal nociceptors invitro and this activation along with immunologic response may trigger pain symptoms and can cause flare up
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