| CTRI Number |
CTRI/2025/01/079237 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
One-Year Follow-Up Study on Periapical Healing After Single-Visit Root Canal Treatment Using Two Different Sealants |
|
Scientific Title of Study
|
Periapical healing outcome of two different sealants in single visit RCT: 1 year follow - up study |
| 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 R Jesanth Joel |
| Designation |
Post graduate - MDS |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
Room no.6
Department of conservative Dentistry and endodontics
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH,
129, CMH compound,
East veli street,
old kuyavarpalayam road,
Madurai, tamilnadu, India
No.18,
Ramaiya Street,
Jaihindpuram
Madurai
TAMIL NADU
625001
India |
| Phone |
08248494531 |
| Fax |
|
| Email |
jesanthjoel96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of Conservative Dentistry and endodontics |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
Room no. 6
Department of conservative dentistry and Endodontics
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH,
129, CMH compound,
East veli street,
old kuyavarpalayam road,
Madurai, tamilnadu, India
Room no. 6
Department of conservative dentistry and Endodontics
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH,
129, CMH compound,
East veli street,
old kuyavarpalayam road,
Madurai, tamilnadu, India
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of Conservative Dentistry and endodontics |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
Room no. 6
Department of conservative dentistry and Endodontics
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH,
129, CMH compound,
East veli street,
old kuyavarpalayam road,
Madurai, tamilnadu, India
Room no. 6
Department of conservative dentistry and Endodontics
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH,
129, CMH compound,
East veli street,
old kuyavarpalayam road,
Madurai, tamilnadu, India
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSI College of dental sciences and Research, Madurai |
|
|
Primary Sponsor
|
| Name |
Dr Jesanth Joel |
| Address |
DEPARTMENT OF CONSERVATIVE DENTIISTRY AND ENDODONTICS
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
madurai - 625001 |
| 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 Jesanth Joel R |
CSI College of Dental Sciences and Research |
Room no. 6, Department of conservative Dentistry and Endodontics, 129 CMH Compound, East veli street, Madurai, TamilNadu, 625001
Madurai
TAMIL NADU |
8248494531
jesanthjoel96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioceramic sealer |
Single visit root canal treatment using SafeEndo BioActive RCS Root Canal Sealant, 12 months follow - up |
| Comparator Agent |
Zinc Oxide Eugenol |
Single visit root canal treatment using Zinc Oxide Eugenol Root canal sealer, 12 months follow - up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 – 70 years
2. Anteriors, premolars and molars
3. Uncomplicated non vital teeth with sinus
tract , intraoral and extraoral swelling.
4. Asymptomatic non vital teeth with presence of
periapical lesion |
|
| ExclusionCriteria |
| Details |
1. Patient not willing for recall visits
2. Patients who cannot keep mouth open for long
duration (TMJ disorders)
3. Cases with continuous flow of pus through the canal during Root Canal Treatment (Weeping canal).
4. Calcified, severely curved canals
5. Periodontally compromised teeth
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiographic evaluation of healing of periapical lesion |
Radiographic evaluation of healing of periapical lesion after 1 year. Clinical evaluation of pain intensity 1st day, 2nd day and 7th day after completion of single visit root canal treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain after single visit root canal treatment |
1st day, 2nd day, 7 days after single visit root canal treatment |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 present clinical and radiographic evaluation was planned for comparing the radiographic periapical healing and pain intensity following single visit Root canal Treatment in non - vital teeth with raiographic periapical lesion using two different root canal sealers namely, Bioceramic sealer(Bioactive RCS) and Zinc oxide eugenol sealer. |