| CTRI Number |
CTRI/2026/01/101168 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Different Intracanal Medications Affect Pain After Root Canal Treatment in Diabetic Patients |
|
Scientific Title of Study
|
Effect of Various Intracanal Medicaments on the Incidence and Intensity of Post Operative Pain in Patients with Diabetes Mellitus : A Randomized Controlled Clinical 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 |
SHREYA RASHI |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT DENTAL COLLEGE |
| Address |
Room no 204, b block, faculty of dental science, dept of cons endo, first floor, SGT dental college, gurugram
SGT UNIVERSITY, BUDHERA,GURGAON
Gurgaon
HARYANA
122505
India |
| Phone |
9667802892 |
| Fax |
|
| Email |
rashishreya10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mamta Singla |
| Designation |
Professor |
| Affiliation |
SGT DENTAL COLLEGE |
| Address |
Room no 204, B block, faculty of dental science, dept of cons endo, first floor, SGT dental college, gurugram
SGT UNIVERSITY, BUDHERA,GURGAON
Gurgaon
HARYANA
122505
India |
| Phone |
9891381349 |
| Fax |
|
| Email |
mamta.singla@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
SHREYA RASHI |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT DENTAL COLLEGE |
| Address |
Room no 204, b block, faculty of dental science, dept of cons endo, first floor, SGT dental college, gurugram
SGT UNIVERSITY, BUDHERA,GURGAON
Gurgaon
HARYANA
122505
India |
| Phone |
9667802892 |
| Fax |
|
| Email |
rashishreya10@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT University, Faculty of Dental Sciences, Department of Conservative dentistry and endodontics |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 SHREYA RASHI |
SGT DENTAL COLLEGE |
ROOM 204,
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, SGT DENTAL COLLEGE, BUDHERA, GURGAON, HARYANA
Gurgaon
HARYANA |
9667802892
rashishreya10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SGTDCHRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intracanal medicament |
1. Dexamethasone (Dexona 4 mg in the form of powder mixed with saline to form a moderately thick paste)
2. Diclofenac (Diclom 50mg in the form of powder mixed with Saline to form a moderately thick paste)
3.Triple Antibiotic Paste (minocycline 100mg, metronidazole 400mg, Ciproflaxacin 500mg are taken in the form of powder and mixed in the ratio 1:1:1 , then with 0.3 ml of Saline to form a moderately thick paste |
| Comparator Agent |
Intracanal medicament |
Calcium hydroxide powder mixed with Saline in the ratio 1:1 to form a moderately thick paste . This medicament will be placed inside the canal using rotary file in the counterclockwise direction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with controlled diabetes [HbA1C levels (6-7.65%)]
Mature mandibular permanent teeth with symptomatic irreversible pulpitis.
Teeth having sufficient tooth structure for adequate isolation.
No history of previous endodontic therapy.
No history of trauma to the involved tooth.
Age criteria: between 18 to 60 years.
Ability to understand and provide informed consent
|
|
| ExclusionCriteria |
| Details |
immunocompromised patients, pregnant, lactating females.
Patients who have a positive history of analgesic intake within past 3 days.
Patients who have a positive history of antibiotics intake in the last month.
• Patients with known history of allergy to the drugs in study.
Patients with radiographic evidence periapical pathology.
Periodontally compromised teeth
Calcified roots.
Patients with known history of peptic ulcers or gastrointestinal bleeding.
Neurologic patients.
• Psychiatric patients who are not able to rate the pain.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain levels measured and compared |
4hrs, 8hrs, 12hrs, 24hrs, 48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
24/01/2026 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 aim of present randomized double blinded clinical trial is to evaluate the incidence and intensity of postoperative pain in patients with diabetes following root canal treatment for teeth with Symptomatic Irreversible Pulpitis in relation to the effects of Calcium Hydroxide, Dexamethasone, Diclofenac, Triple Antibiotic Paste used as intracanal medicament.
OBJECTIVES
1. To evaluate the effect of Diclofenac as an intracanal medicament on the postoperative pain after endodontic treatment of the teeth with irreversibly inflamed pulps.
2. To evaluate the effect of Dexamethasone as an intracanal medicament on the postoperative pain after endodontic treatment of the teeth with irreversibly inflamed pulps.
3. To evaluate the effect of Triple Antibiotic Paste as an intracanal medicament on the postoperative pain after endodontic treatment of the teeth with irreversibly inflamed pulps.
4. To evaluate the effect of Calcium Hydroxide as an intracanal medicament on the postoperative pain after endodontic treatment of the teeth with irreversibly inflamed pulps.
5. To evaluate the incidence and intensity of the post operative pain in each case.
6. To compare the efficacy of the above stated intracanal medicament with each other and to determine the drug of choice among these to best facilitate post operative pain in patients with diabetes.
MATERIALS AND METHODOLOGY
MATERIALS AND ARMAMENTARIUM
Diclofenac - (Diclom 50mg)
Dexamethasone –(Dexona 4mg )
Triple Antibiotic Paste ( Minocycline 100mg, Metronidazole 400mg, Ciprofloxacin 500 mg in the ratio 1:1:1)
Calcium Hydroxide
Local anaesthesia (2% lidocaine with adrenaline 1:80,000)
24gauge needle and syringe
Electric pulp tester
Endo ice
Rubber dam kit
Air rotor handpiece
Large round diamond point.
Tapered fissure diamond point
Endo access burs
Endo-Z bur
DG-16 endodontic probe
Hand files
Electronic apex locator
Endomotor
Rotary files
30gauge trunatomy double side vented irrigation needles
Endoactivator
2.5% sodium hypochlorite solution
Normal saline
EDTA
Absorbent paper points
Gutta percha points
Ah plus sealer
Cavit
|