| CTRI Number |
CTRI/2024/09/074529 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Postoperative pain after Ceraseal, MTA Fillapex, and AH Plus sealer in single visit root canal treatment. |
|
Scientific Title of Study
|
Comparative Evaluation of Ceraseal, MTA Fillapex and AH Plus sealer on postoperative pain after single visit root canal treatment - A Randomized controlled Clinical 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 |
Monal Ajay Kohok |
| Designation |
Post graduate student |
| Affiliation |
Nair Hospital Dental College |
| Address |
301, third floor, Nair Hospital Dental College, opposite to Maratha mandir theatre, Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9730933604 |
| Fax |
|
| Email |
kohokmonal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Mandwe |
| Designation |
Associate professor |
| Affiliation |
Nair Hospital Dental College |
| Address |
301, third floor, Nair Hospital Dental College, opposite to Maratha mandir theatre, Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9220524842 |
| Fax |
|
| Email |
drmandwe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Mandwe |
| Designation |
Associate professor |
| Affiliation |
Nair Hospital Dental College |
| Address |
301, third floor, Nair Hospital Dental College, opposite to Maratha mandir theatre, Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9220524842 |
| Fax |
|
| Email |
drmandwe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nair Hospital Dental College. |
|
|
Primary Sponsor
|
| Name |
Monal Ajay Kohok |
| Address |
301, third floor, Nair Hospital Dental College, opposite to Maratha mandir theatre, Mumbai Central |
| Type of Sponsor |
Other [Self] |
|
|
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 Monal Ajay Kohok |
Nair Hospital Dental College |
Room number 301, Third Floor, Department of Conservative Dentistry and Endodontics, Nair Hospital Dental College, Opposite to Maratha Mandir Theatre, Mumbai Central, Mumbai 400008, Maharashtra, India
Mumbai
MAHARASHTRA |
9730933604
kohokmonal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Nair Hospital Dental College, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AH Plus resin Sealer |
Post operative pain after single visit root canal treatment in mandibular first molars using AH Plus sealer. The follow up of pain will be for 6, 12, 24, and 48 hours and 3rd and 7th day. |
| Intervention |
Ceraseal, MTA Fillapex |
Post operative pain after single visit root canal treatment in mandibular first molars using Ceraseal and MTA Fillapex. The follow up of pain will be for 6, 12, 24, and 48 hours and 3rd and 7th day. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Teeth necessitating endodontic treatment on asymptomatic permanent mandibular first molars, confirmed as vital through pulp sensitivity tests, will be selected for this study from the regular patient pool. The treatment procedure will be thoroughly explained to each patient in their native language to ensure comprehension. Informed written consent will be obtained prior to participation, adhering to ethical standards and ensuring patient autonomy. |
|
| ExclusionCriteria |
| Details |
Pregnant patients, medically compromised patients (with immunosuppressive, systemic diseases, patients on medications), and patients below 21 years and above 30 years of age will be excluded. |
|
|
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 |
To compare the incidence and intensity of postoperative
pain following single-visit root canal treatment using
Ceraseal, MTA Fillapex and AH Plus sealer among patients. |
6, 12, 24, 48 hours and 3rd and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the need for analgesic medication consumption
among patients in each sealer group to manage
postoperative pain. |
6, 12, 24, 48 hours and 3rd and 7th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Single-visit root canal treatment offers numerous benefits that significantly enhance patient experience and clinical outcomes. One of the most compelling advantages is the substantial reduction in treatment time, allowing patients to complete their procedure in one appointment and minimizing disruption to their daily lives. Additionally, this approach can alleviate dental anxiety, as it reduces the stress associated with multiple appointments, including the need for repeated anaesthetic injections and rubber dam placements. Importantly, single-visit treatment significantly lowers the risk of root canal contamination and bacterial regrowth, which can occur with prolonged treatment intervals. By maintaining continuity, clinicians can better understand canal anatomy, tooth length, and other vital parameters, enhancing treatment precision while avoiding complications such as inter-visit leakage and loss of temporary seals. However, it is essential to acknowledge certain limitations of single-visit procedures. The absence of diagnostic controls available in multi-visit treatments may hinder the ability to culture samples for assessing the effectiveness of biomechanical preparation or to evaluate tissue responses post-treatment. Moreover, in the event of a flare-up or complications, emergency interventions can become more complex, requiring procedures such as artificial fistulation or the removal of fillings. Ultimately, while single-visit root canal treatment provides significant advantages, both patients and clinicians must weigh these benefits against potential limitations to ensure informed decision-making for optimal dental health outcomes. This randomized controlled trial aims to assess postoperative pain following single-visit root canal treatment in mandibular first molars, comparing the efficacy of three endodontic sealers: Ceraseal, MTA Fillapex, and AH Plus. Recognizing that pain perception is a complex and subjective experience influenced by numerous physical and psychological factors, this study will employ the Visual Analog Scale (VAS) for pain measurement. The VAS, a 100 mm horizontal line anchored by descriptive terms at each end, will be used to quantify patients’ pain levels. Participants will be instructed to mark their perceived pain at specified intervals: 6 hours, 12 hours, 24 hours, 48 hours, 3 days, and 7 days post-treatment. This methodology aims to provide a robust comparison of postoperative pain associated with the different sealers under investigation. |