| CTRI Number |
CTRI/2024/06/069443 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate which sealer shows good healing outcome and less post operative pain. |
|
Scientific Title of Study
|
Effect of bioceramic sealers on healing outcome and post operative pain: an in vivo 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 Ankita Sharma |
| Designation |
MDS( post graduate) |
| Affiliation |
ITS dental college hospital and research centre, greater noida |
| Address |
Room no. 7, department of conservative dentistry and endodontics, ITS dental college hospital and research centre, 47, knowledge park 3
Gautam Buddha nagar
uttarpradesh
201308
india
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9811646919 |
| Fax |
|
| Email |
ankitarakeshsharma2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Kochhar |
| Designation |
Professor and head of the department |
| Affiliation |
ITS dental college hospital and research centre, greater noida |
| Address |
room no.7 department Of conservative dentistry And endodontics
ITS dental college
greater noida,47, knowledge park-3
gautam buddha nagar
uttar pradesh
201308
india
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9810034451 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Kochhar |
| Designation |
Professor and head of the department |
| Affiliation |
ITS dental college hospital and research centre greater noida |
| Address |
room no.7 department Of conservative dentistry And endodontics
ITS dental college
greater noida,47, knowledge park-3
gautam buddha nagar
uttar pradesh
201308
india
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9810034451 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| room no.7, department of conservative dentistry and endodontics,ITS dental college, greater noida, 47 knowledge park 3,201308, uttarpradesh, india |
|
|
Primary Sponsor
|
| Name |
ITS dental college hospital and research centre |
| Address |
room no 7 department of conservative dentistry and endodontics
ITS dental college
greater noida,47, knowledge park 3,201308,uttar Pradesh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ankita Sharma |
its dental college hospital and research centre greater noida |
room no 7,department of conservative and endodontics,
its dental college hospital and research centre
greater noida
gauttam buddha nagar
uttar pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9811646919
ankitarakeshsharma2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS dental college hospital and research centre institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bio ceramic sealers |
Bio ceramic sealers is used for obturation to check the status of healing at 3 months, 6 months and 12 months and post operative pain at 4 hours, 24 hours and 48 hours |
| Comparator Agent |
Resin based sealer |
Resin based sealers is used for obturation to check the status of the healing at 3 months, 6 months and 12 months and post operative pain at 4 hours, 24 hours and 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female genders.
2.Age of patient between 18-60 years.
3.Teeth with fully formed apices requiring root canal therapy.
4.Posterior teeth.
5.Horizontal supracrestal root fracture.
6.Good health(AMERICAN SOCIETY OF ANESTHESIOLOGISTS CLASSIFICATION I AND II.)
7.Presence of periapical radiolucency upto 5mm.
8.Irreversible pulpitis
( SYMPTOMATIC/ ASYMPTOMATIC)
9. Patient consenting to be part of this study. |
|
| ExclusionCriteria |
| Details |
1. Use of any analgesic, anti inflammatory or antibiotics before treatment.
2. Previous endodontic intervention.
3. Evidence of vertical root fracture.
4. Non restorable teeth.
5. Patient who were unable to communicate their symptoms because of psychological disorders.
6. Tooth was affected by cracks, severe periodontal bone loss due to chronic periodontitis accompanying mobility of tooth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate healing outcome of bioceramic sealer
2. to evaluate healing outcome of resin based sealer
3. to compare healing outcome of bioceramic sealer
4. to compare healing outcome of resin based sealer. |
healing will be checked at base line 3 months 6 months and 12 months interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the intensity of pain after obturation using BC sealer and Resin based sealer.2.To evaluate and compare the intensity of pain after obturation using BC sealer and Resin based sealer.
|
pain will be measured by NRS scale. observation will be done at 4hr 24hr 48hr |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| Date of Study Completion (India) |
28/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
A clinical diagnosis for the patient reporting to the Department of Conservative Dentistry and Endodontics will be made and patients will be selected according to the inclusion criteria mentioned in the study. A preoperative radiograph and CBCT will be taken to assess the extent of caries and the size of periapical radiolucency which should be upto 5mm.Pulp vitality test(cold: ENDO ICE) and EPT will be performed to confirm the irreversible of the pulp. Included patients will be informed about the study and explained in detail about the procedure of the study and requirement for the same. A solution of 2% lidocaine HCL and 1:100000 epinephrine will be used to anaesthetize each subject. Occlusal reduction will be done to avoid postoperative pain. A sterile round bur #2 will be used to get access to the pulp chamber coronally after debriding the tooth structure of any old restoration and secondary decay around the access opening site. To establish the working length, radiographic method will be employed. An initial glide path will be prepared with a hand file after the working length has been established. Canal orifice enlargement will be done with SX hand protaper file for each patient. Continue with the root canal treatment by doing further biomechanical preparation with size F1 until the projected working length is reached, irrigation with 2.5 percent NaOCl and saline will be performed as per gold standard, and the final rinse will be done using 3ml of 17% EDTA. The canal will then be dried using paper points. Depending upon the type of sealer used 100 patients will be randomly allocated into 2 groups of 50 patients each. Group 1 (n=50): Bioceramic sealer(bio c sealer, Angelus) Group 2 (n=50): Resin based sealer (AH plus, Dentsply) Both the sealers will be mixed as per manufacturers instruction. Root canal walls will be coated with the sealer with the help of master cone GP followed by lateral compaction with accessory GP cone. Gutta percha cone will be cut at orifice level. After obturation teeth will be assessed for Post operative pain Healing of apical radiolucency If patient complains of pain after obturation a escape drug (diclofenac sodium tablets 40mg)will be given. Post Operative Pain will be checked at 4 hr, 24 hr and 48 hr. Pain will be measured by NRS Scale. Healing will be checked by Periapical Radiograph & CBCT. Periapical Radiograph Will Be Taken At: pre operative 3 months 6 months 12 months CBCT Will Be Done At: Pre operative After 12 months Healing will be checked by Periapical Index (PAI) Score and Cone-beam computed tomography – Periapical index (CBCT-PAI) |