| CTRI Number |
CTRI/2023/03/050856 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Dexamethasone and Triamcinolone Acetonide on Post-Operative Pain after Root Canal Treatment of Teeth with Irreversible Pulpitis |
|
Scientific Title of Study
|
Efficacy of Pre-operative submucosal injection of Dexamethasone And Triamcinolone Acetonide on Post-Operative Pain following endodontic treatment of teeth with Irreversible Pulpitis: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PARI ANAND |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
THE OXFORD DENTAL COLLEGE |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS( 2ND FLOOR)
THE OXFORD DENTAL COLLEGE, BOMMANAHALLI, NH 44, HONGASANDRA, BANGALORE-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
8017036089 |
| Fax |
|
| Email |
parianand1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYAKUMAR T |
| Designation |
PROFESSOR |
| Affiliation |
THE OXFORD DENTAL COLLEGE |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY, (2ND FLOOR)
THE OXFORD DENTAL COLLEGE, BOMMANAHALLI, NH 44, HONGASANDRA, BANGALORE-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
8553538792 |
| Fax |
|
| Email |
dr.jayreddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PARI ANAND |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
THE OXFORD DENTAL COLLEGE |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,( 2NF FLOOR)
THE OXFORD DENTAL COLLEGE, BOMMANAHALLI, NH 44, HONGASANDRA, BANGALORE-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
8017036089 |
| Fax |
|
| Email |
parianand1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| THE OXFORD DENTAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
DR PARI ANAND |
| Address |
THE OXFORD DENTAL COLLEGE, BOMMANAHALLI. BANGALORE-560068 |
| Type of Sponsor |
Other [Individual] |
|
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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 PARI ANAND |
THE OXFORD DENTAL COLLEGE |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,(2ND FLOOR),
BOMMANAHLLI, NH44, HONGASANDRA, BANGALORE.
Bangalore
KARNATAKA |
8017036089
parianand1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, THE OXFORD DENTAL COLLEGE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP I- 2ml Saline(CONTROL) GROUP |
In group 1: 2 ml saline will be administrated submucosally to the control group after local anaesthesia into the mucobuccal fold of teeth.
|
| Intervention |
GROUP II- dexamethasone (8mg)
GROUP III-triamcinolone acetonide (40mg) |
In group 2: 8 mg, 2 ml dexamethasone will be administrated after local anesthesia ,submucosally into the mucobuccal fold of the teeth.
In group 3: 40 mg triamcinolone acetonide, dissolved in 2 ml injection water will be administrated after local anesthesia, submucosally into the mucobuccal fold of the teeth.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• Healthy adults aged 18-50 years of age with symptomatic irreversible pulpitis.
• Patients with good general health and no chronic systemic diseases.
• Patients with a radiographically normal periapical region
|
|
| ExclusionCriteria |
| Details |
• Teeth with periapical pathology, abscess, calcified canals or aberrant anatomy.
• Patients with History of allergy to Local anesthesia or any other experimental drugs.
• Patients with systemic disorders, pregnant and breastfeeding mothers and any conditions that contradict use of steroids.
• Patients with use of analgesics or anti-inflammatory drugs 12 hours prior to the procedure.
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative pain using Heft-Parker visual analogue scale (HP VAS) |
PRE-OP, POST-OP AFTER 6HRS, 12HRS, 24HRS,48HRS AND 72 HRS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POST OPERATIVE PAIN USING Heft-Parker visual analogue scale (HP VAS) |
PRE-OP,POST-OP AFTER 6HRS, 12HRS,24HRS,48HRS, 72 HRS |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2023 |
| Date of Study Completion (India) |
10/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The aim of the study was to evaluate the effects of submucosal single doses of dexamethasone and triamcinolone acetonide on postoperative pain after single visit root canal treatment of teeth with symptomatic irreversible pulpitis. Thirty patients were selected and allocated in three groups. Group I received saline (control), Group II received dexamethasone (8mg) and Group III received triamcinolone acetonide (40mg) before endodontic treatment is initiated. Root canal treatment was performed in a single appointment for all the participants. Post-operative pain was assessed using Heft-Parker visual analogue scale (HP VAS). The results showed that Preoperative doses of corticosteroids resulted in a
decrease of post endodontic pain following single visit root canal treatment of
teeth with symptomatic irreversible pulpitis
|