CTRI Number |
CTRI/2017/08/009220 [Registered on: 01/08/2017] Trial Registered Retrospectively |
Last Modified On: |
31/07/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Does Benzydamine hydrochloride oral rinses decrease pain and drug requirement after molar tooth extraction |
Scientific Title of Study
|
Randomized controlled trial to compare oral analgesic requirements and patient satisfaction in using oral non-steroidal anti-inflammatory or benzydamine hydrochloride oral rinses after mandibular third molar extraction: A pilot study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Devalina Goswami |
Designation |
Assistant Professor |
Affiliation |
AIIMS, New Delhi |
Address |
Room No 506, CDER, AIIMS Room No 506, CDER, AIIMS New Delhi DELHI 110029 India |
Phone |
9971196699 |
Fax |
|
Email |
drdevalina@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Devalina Goswami |
Designation |
Assistant Professor |
Affiliation |
CDER, AIIMS, New Delhi |
Address |
Room No 506, CDER, AIIMS, New Delhi Room No 506, CDER, AIIMS South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
drdevalina@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Devalina Goswami |
Designation |
Assistant Professor |
Affiliation |
CDER, AIIMS, New Delhi |
Address |
ROOM NO 506, CDER, AIIMS Room No 506, CDER, AIIMS South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
drdevalina@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS New Delhi |
Address |
Dept of Anaesthesia, 5th Floor, New Delhi |
Type of Sponsor |
Research institution |
|
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 Devalina Goswami |
All India Institute of Medical Sciences New Delhi |
Room No 506, Department of Anaesthesiology, Centre for Dental Education and Research South DELHI |
9971196699
drdevalina@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committe, All India Institute of Medical Sciences, New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Third Molar pathology requiring extraction, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NSAID Vs Benzydamine hydrochloride |
oral non-steroidal anti-inflammatory drugs or benzydamine hydrochloride oral rinses after mandibular third molar extraction |
Comparator Agent |
Pain, Trismus, Analgesia requirement |
Above paramenters will be assed on 3rd and 7th Post operative day |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patients 18years and above coming for fully erupted mandibular third molar extraction
2. Patients belonging to ASA physical statusI&II. |
|
ExclusionCriteria |
Details |
1.Tooth requiring surgical extraction
2.Periodontally weak tooth
3.Tooth associated with peri-apical pathology
4.Tooth associated with fracture
5.Tooth with cellulitis or abscess
6.Tooth where adjacent 2nd molar can be a source of pain- eg. caries
7.Patients with other conditions that may alter the healing capacity post-extraction- like diabetes mellitus, those receiving bisphosphonate therapy or post radiotherapy patients
8.Patients with hypersensitivity to NSAIDS, peptic ulcer,GI bleed and myocardial infarction.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Scoring of pain in VAS.
Trismus
Total number of analgesics consumed
Satisfaction level of the patient
|
3rd and 7th post operative day-
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Pain, Trismus, Analgesic requirement |
3rd to 7th Post operative day |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
15/05/2016 |
Date of Study Completion (India) |
10/04/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
This article not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Introduction: Third molar extraction is associated with considerable pain and discomfort. Numerous drugs e.g., NSAIDS, COX 2 inhibitors, opioids have been studied. Pre-emptive analgesia with dexamethasone or local anesthetic infiltration has also been used. Topical application of analgesic drugs have been found to be useful for oral ulcers and post tonsillectomy pain, but it has never been studied for control of pain following third molar extraction. We tried to assess the analgesic effect of Benzydamine hydrochloride, a topical NSAID oral rinse in the control of post operative pain following third molar extraction. Methodology: A randomized controlled trial was conducted in 40 patients scheduled for fully erupted third molar extraction. They were divided into two groups. Group A- Benzydamine hydrochloride mouth wash and Group B- Normal saline gargle with oral analgesics (Ibuprofen and Paracetamol). Ibuprofen and Paracetamol was the rescue analgesic drug in Group A. Patients were doing their self evaluation at home while in hospital patients were evaluated on 3rd and 7th post-extraction day. Pain (VAS score), trismus, total number of analgesics consumed and satisfaction level of the patient on Global assessment of pain was recorded. Results: Intensity of pain (VAS) in group A was more than in group B on the 3rd and 7th post operative day but was statistically insignificant. Analgesics consumed in group A was less than group B on 3rd 7th post operative day and also statistically insignificant. Similarly trismus on 3rd and 7th post operative day had a P value of 0.609 and 0.490 respectively and patient satisfaction level on 3rd and 7th post operative had P values of 0.283 and 0.217respectively. Conclusion: Use of Benzydamine hydrochloride gargle did result in consumption of less oral analgesics but it had no statistically significant value. Also there were no statistically significant differences in post operative pain scores or satisfaction level between patients using normal saline gargle and those using Benzydamine hydrochloride gargle. |