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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  
None 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Dept of Anaesthesia, 5th Floor, New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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