| CTRI Number |
CTRI/2025/08/092756 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Intracanal Medicaments like calcium hydroxide TAP and bioceramic for Pain Relief in Symptomatic Apical Periodontitis |
|
Scientific Title of Study
|
Comparative evaluation of Calcium Hydroxide, Triple Antibiotic Paste and Bioceramic as intracanal medicament on endodontic interappointment pain in patients with symptomatic apical periodontitis – A Randomised Control 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 |
Prathamesh Sawant |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and research Center Nagpur |
| Address |
Department of Conservative Dentistry and Endodontics Ranjeet Deshmukh Dental College and Research Center Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7038517216 |
| Fax |
|
| Email |
sawantprathamesh60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetana Makade |
| Designation |
Associate Professor |
| Affiliation |
Ranjeet Deshmukh Dental College and research Center Nagpur |
| Address |
Department of Conservative Dentistry and Endodontics Ranjeet Deshmukh Dental College and Research Center Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9372690962 |
| Fax |
|
| Email |
makade.chetana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prathamesh Sawant |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and research Center Nagpur |
| Address |
Department of Conservative Dentistry and Endodontics Ranjeet Deshmukh Dental College and Research Center Nagpur
MAHARASHTRA
440019
India |
| Phone |
7038517216 |
| Fax |
|
| Email |
sawantprathamesh60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre Nagpur |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| 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 Prathamesh Sawant |
Department Of Conservative Dentistry and Endodontics |
311 Ranjeet Deshmukh Dental College and research Center
Nagpur
MAHARASHTRA |
07038517216
sawantprathamesh60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutuional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 Calcium Hydroxide intracanal medicament 2 Triple Antibiotic Paste intracanal medicament 3 Bioceramic intracanal medicament |
20% calcium hydroxide intracanal dressing paste
Triple antibiotic paste Ciprofloxacin, minocycline, metronidazole mixture in a proportion of 1:1:1 by weight
Bio-C temp intracanal medicament -2gm will be used in the study |
| Comparator Agent |
1.Triple Antibiotic Paste
2.Bioceramic |
1.Ciprofloxacin, minocycline, metronidazole mixture in a proportion of 1:1:1 by weight
2.Bio-C temp intracanal medicament -2gm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age of the patient 18 to 50 years will be included in the study
2. Both males and females
3. Systemically healthy patients (Category: ASA Class 1)
4. Single rooted tooth diagnosed with symptomatic apical periodontitis.
5. Teeth with necrotic pulp that gave a negative response to vitality testing.
|
|
| ExclusionCriteria |
| Details |
1. Non-restorable teeth
2. Presence of endo-perio lesion
3. Teeth associated with acute or chronic apical abscess
4. Teeth with chronic periodontitis
5. Teeth with open apex
6. Teeth with calcified canals
7. Teeth with severe dilaceration
8. Teeth with internal/external root resorption
9. Patient who were allergic to medication that were used in study
10. Patient who were taking medicine that could influence pain perception
11. Patient that had serious medical illness
12. Patient with systemic disorder
13. Patient with immunocompromised disease such as AIDS or HBV.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate Calcium hydroxide Triple Antibiotic Paste and Bioceramic as intracanal medicaments on endodontic interappointment pain in patients with symptomatic apical periodontitis
|
6hrs 48hrs 72 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. To compare Calcium hydroxide, Triple Antibiotic Paste and Bioceramic as intracanal medicaments on endodontic interappointment pain in patients with symptomatic apical periodontitis.
3. To analyse Calcium hydroxide, Triple Antibiotic Paste and Bioceramic as intracanal medicaments on endodontic interappointment pain in patients with symptomatic apical periodontitis.
|
6hrs 48hrs 72 hrs
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
09/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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 randomized controlled clinical study
aims to assess the comparative effectiveness of three intracanal
medicaments—Calcium Hydroxide, Triple Antibiotic Paste (TAP), and Bioceramic
compounds—on reducing interappointment pain in patients with symptomatic apical
periodontitis. Endodontic treatment, while effective for tooth preservation,
often presents challenges like pain between appointments, influenced by factors
such as necrotic pulp and bacterial infections.
Calcium Hydroxide is known for its antimicrobial effects, while TAP offers
broad-spectrum antibacterial action but may cause dentin weakening and tooth
discoloration. Bioceramics, being a recent advancement, show promise due to
their superior biocompatibility and ability to stimulate healing.
In this in vivo study, 80 patients aged between 18 to 50 years were selected
based on strict inclusion and exclusion criteria. They were randomly divided
into four groups, each receiving a different medicament, with one serving as a
control. Pain levels were assessed using the Wong-Baker FACES Pain Rating Scale
at several intervals post-treatment (6, 24, 48, and 72 hours). The outcomes
were analyzed statistically to determine which medicament offers superior pain
relief. |