| CTRI Number |
CTRI/2024/10/075485 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Chances of Pain and swelling after Root canal treatment- one sitting versus multiple sitting in cases of infection at root tip (using Calcium with iodoform inside tooth) |
|
Scientific Title of Study
|
Incidences of flare ups after single visit and multiple visit endodontic therapy with and without metapex in permanent teeth with periapical lesion |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Sharma |
| Designation |
Ph.D Research Scholar |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre, Moradabad |
| Address |
Room no. 4, Department of Conservative Dentistry and Endodontics, 4th floor, TMDC&RC, TMU, NH-24, Delhi road, Moradabad, U.P (244001)
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7017996796 |
| Fax |
|
| Email |
anjali357512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre, Moradabad |
| Address |
Room no.4, Department of Conservative Dentistry and Endodontics, TMDC&RC,TMU, NH-24, Delhi road, Moradabad, U.P (244001)
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7618192324 |
| Fax |
|
| Email |
rohit357512@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Sharma |
| Designation |
Ph.D Research Scholar |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre, Moradabad |
| Address |
Room No.4, Department of Conservative Dentistry and Endodontics, 4th floor, TMDC&RC, TMU, NH-24, Delhi road, Moradabad, U.P (244001)
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7017996796 |
| Fax |
|
| Email |
anjali357512@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Dental College and Research Centre, Moradabad, Uttar Pradesh (244001), India |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
TMU, NH-24, Delhi road, Moradabad, Uttar Pradesh (244001),India |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rohit Kumar Sharma |
TMU, NH-24, Delhi road, Moradabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Sharma |
Teerthanker Mahaveer Dental College and Research Centre |
Room No.4, Department of Conservative Dentistry and Endodontics, 4th floor, TMDC&RC TMU, NH-24, Delhi road, Moradabad (244002), INDIA
Moradabad
UTTAR PRADESH |
7017996796
anjali357512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Teerthanker Mahaveer Dental College and Research Centre, Delhi road, Moradabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metapex with zinc oxide eugenol in multiple sitting |
Metapex with zinc oxide eugenol will be used in multiple sitting RCT in presence of periapical lesion |
| Intervention |
Metapex with zinc oxide eugenol in single sitting |
Metapex with zinc oxide eugenol will be used in single sitting RCT in presence of periapical lesion |
| Comparator Agent |
Zinc oxide eugenol in multiple sitting RCT |
Metapex will not be used in multiple sitting RCT in presence of periapical lesion. Only zinc oxide eugenol used as sealer. |
| Comparator Agent |
Zinc oxide eugenol in Single sitting RCT |
Metapex will not be used in single sitting RCT in presence of periapical lesion. Only Zinc oxide eugenol will be used |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Age above 14 years with deep caries approaching or involving pulp and indicated for a root canal treatment
2)Gender both male and females
3)Free from any systemic disease
4)No history of intake of medication for that complaint for last 24 hrs
5)Periapical lesion
|
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating women
2)Not giving proper consent
3)Root fractures
4)Medically compromised patients
5)Preoperative intra oral or extra oral swelling
6)More than one third root resorption
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain- Heft Parker Visual Analog Scale |
1, 2, 3, 4, 5, 6, 7 day in between and post obturation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Swelling- Verbal rating scale |
1, 2, 3, 4, 5, 6, 7 day in between and post obturation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anjali357512@gmail.com].
- For how long will this data be available start date provided 01-11-2024 and end date provided 01-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
The
Purpose of the present study is to comparatively evaluate the
incidences of flare‑up after single‑ and multiple‑visit endodontic therapy
with and without medicament (metapex) in permanent teeth with periapical
lesion. Hypothesis of our study is that there will be more chance of flare ups in cases of single sitting RCT whether in presence or absence of Metapex in cases of asymptomatic periapical lesion.
|
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