| CTRI Number |
CTRI/2025/02/080129 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Pain After Single-Visit Root Canal Treatments Using New Curcumin Sealers vs Traditional Sealers in Infected Teeth: A Study |
|
Scientific Title of Study
|
Comparative Analysis of Postoperative Pain in Single-Visit Endodontic Treatment using CurowhiteTM Enhanced Sealers versus Zinc Oxide Eugenol Sealer in mandibular premolars: 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 Rathna Piriyanga R S |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
Room No. 6, Department of Conservative Dentistry and Endodontics, CSI College of dental Sciences and Research, East Veli street, Madurai 625001
Madurai
TAMIL NADU
625001
India |
| Phone |
8015508427 |
| Fax |
|
| Email |
rathnapiriyanga14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeth Deepika |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Room No. 6, Department of Conservative Dentistry and Endodontics, CSI College of dental Sciences and Research, East Veli street, Madurai 625001
TAMIL NADU
625001
India |
| Phone |
8015508427 |
| Fax |
|
| Email |
geethdeepika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Sherwood I |
| Designation |
Professor and Head |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH,MADURAI
Madurai
TAMIL NADU
625003
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aurea Biolabs (P) Limited,
Regional Office : 809, Medows , Sahar Plaza, JB Nagar, Andheri East, Mumbai 400 059 |
|
|
Primary Sponsor
|
| Name |
Aurea Biolabs (P) Limited |
| Address |
Regional Office : 809, Medows , Sahar Plaza, JB Nagar, Andheri East, Mumbai 400 059 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Rathna Piriyanga |
CSI College of Dental Sciences and Research |
Room No. 6, Department of Conservative Dentistry and Endodontics, CSI College of dental Sciences and Research, East Veli street, Madurai 625001
Madurai
TAMIL NADU |
8015508427
rathnapiriyanga14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH, INSTITUTIONAL ETHICAL COMMITTEE AND INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Irreverisible pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 Zinc Oxide Eugenol (Control) |
Zinc oxide powder and eugenol liquid will be mixed to form root canal seal consistency |
| Intervention |
GROUP 2 Zinc oxide & Curowhite 1:1 ratio with eugenol |
Zinc oxide powder and curowhite powder will be taken in equal ratio and mixed with eugenol liquid to get root canal sealer consistency |
| Intervention |
GROUP 3 - Zinc oxide & Curowhite (1:1) with antimicrobial blend.
|
Zinc oxide powder and curowhite powder will be taken in equal ratio and mixed with antimicrobial blend |
| Intervention |
GROUP 4 - Zinc oxide + antimicrobial blend |
Zinc oxide powder and antimicrobial blend liquid will be mixed to form root canal sealer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 and 65 years
Single rooted mandibular premolar teeth requiring single-visit endodontic treatment
Teeth with or without periapical lesions
Absence of alterations causing a significant increase in preparation time.
|
|
| ExclusionCriteria |
| Details |
• Presence of pain in more than one tooth in the same quadrant.
• Teeth with open apices.
• Presence of systemic diseases.
• Missing opposing teeth or cracked teeth.
• Pregnant patients.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence and intensity of postoperative pain will be assessed at 24, 48, and 72 hours and 1 week.
Participants will complete a Visual Analog Scale (VAS) questionnaire for pain intensity.
Medication usage data will be collected through patient recall and medication logs.
Adverse events will be documented and reported.
|
24, 48, and 72 hours patient will be reviewed through phone call and after 1 week - clinical review will be done
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Periapical healing using PAI score |
1 week, 6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
03/03/2025 |
| 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="0"
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
|
This study aims to evaluate the effectiveness of Curowhite-enhanced root canal sealers in reducing postoperative pain in single-rooted teeth with irreversible pulpitis, compared to traditional zinc oxide eugenol sealers. In a double-blind randomized controlled trial with 128 participants, patients aged 18-65 with single-rooted mandibular premolars will undergo single-visit root canal treatment. The study will involve four groups: zinc oxide + Curowhite (1:1) + eugenol, zinc oxide + Curowhite (1:1) + antimicrobial blend, zinc oxide + antimicrobial blend, and a control group using zinc oxide + eugenol. Pain levels will be assessed using the Visual Analog Scale (VAS) at 24, 48, and 72 hours, and at 1 week post-treatment. The study will also track the use of additional pain medication and record any adverse events. Statistical analyses will compare pain scores and analgesic requirements among the groups. The findings will help determine the efficacy of Curowhite-enhanced sealers in managing postoperative pain. |