| CTRI Number |
CTRI/2025/02/081404 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Calcium Hydroxide vs Triple Antibiotic Paste: Which is better for treating Tooth Root Infections : A Randomized Controlled Trial |
|
Scientific Title of Study
|
Clinical and Radiographic Assessment of Apical Periodontitis with Calcium Hydroxide vs Triple Antibiotic Paste Both when used along with Chlorhexidine Digluconate as Vehicle : 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 Harnoor |
| Designation |
Postgraduate Resident |
| Affiliation |
Deaprtment of Conservative Dentistry and Endodontics Himachal Dental College Sundernagar |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, Sundernagar, distt Mandi 175019
Sundernagar
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
7696085259 |
| Fax |
|
| Email |
harnoorchadha29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Professor |
| Affiliation |
Deaprtment of Conservative Dentistry and Endodontics Himachal Dental College Sundernagar |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, Sundernagar, distt Mandi 175019
Sundernagar
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
7650000300 |
| Fax |
|
| Email |
drvk9900@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Professor |
| Affiliation |
Deaprtment of Conservative Dentistry and Endodontics Himachal Dental College Sundernagar |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, Sundernagar, distt Mandi 175019
Sundernagar
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
7650000300 |
| Fax |
|
| Email |
drvk9900@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Dental College Sundernagar |
|
|
Primary Sponsor
|
| Name |
Dr Harnoor |
| Address |
Department of Conservative Dentistry and Endodontics , Himachal Dental College and Hospital, Sundernagar
|
| 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 Harnoor |
Himachal Dental College and Hospital, Sundernagar |
Department of Conservative Dentistry and Endodontics , Himachal Dental College and Hospital, Sundernagar
Mandi
HIMACHAL PRADESH |
7696085259
harnoorchadha29@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Himachal Dental College Sundernagar |
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 |
| Comparator Agent |
Calcium Hydroxide is used as a comparator agent and applied as an intracanal medicament for 2 week then will change the medicament again for another 2 weeks |
Calcium Hydroxide is widely recognized for its antimicrobial
properties and its role in promoting apical healing. |
| Intervention |
Triple Antibiotic Paste as an interventional agent
Triple antibiotic paste is applied for 2 weeks then will change the dressing again for next 2 weeks.
Triple antibiotic paste is a combination of Ciprofloxacin 500 mg
Metronidazole 400 mg
Doxycycline 100 mg and applied as intracanal medicament |
Since endodontic infections typically involve a mixture of anaerobic and aerobic bacterial species, a single antimicrobial agent may be insufficient to achieve comprehensive disinfection. To address this, a combination of (Triple Antibiotic Paste) is often
recommended.
Triple Antibiotic Paste is
valued for its broad-spectrum antimicrobial action. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult Patients aged between 18 and 45 years.
2. Single-rooted teeth (anterior and posterior).
3. Teeth with Apical periodontitis.
4. Teeth with necrotic pulp that gave a negative response to vitality testing. |
|
| ExclusionCriteria |
| Details |
1. Non-restorable teeth.
2. Teeth requiring retreatment.
3. Teeth with calcified canals.
4. 5. Teeth with internal/external root resorption.
Patients with serious medical illness.
6. Patients with known allergies to the materials used in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective will focus on
periapical healing |
at the interval of 1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain will be assessed as a secondary
outcome. |
Pain will be evaluated at interval of 1 week, 2 weeks and 1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/03/2025 |
| 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="7"
Days="30" |
|
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
|
Patients will be randomly assigned to two groups: • Group A: Calcium Hydroxide + 2% Chlorhexidine Digluconate • Group B: Triple Antibiotic Paste + 2% Chlorhexidine Digluconate
Procedure: • Patients will undergo endodontic treatment with intracanal medicaments. • Standard protocol will be followed, including anesthesia (2% lignocaine with 1:80,000 adrenaline), rubber dam isolation, caries excavation, access opening, and root canal preparation using Ni-Ti rotary files. • Canals will be irrigated with sodium hypochlorite, normal saline, and 17% EDTA, then dried with sterile paper points.
Intracanal Medication Protocol: • Step I: Intracanal medicament applied, changed after 7 days. • Step II: Medication retained for another 7 days. • After 15 days, the master cone will be selected, and the canals will be obturated. |