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CTRI Number  CTRI/2024/03/063581 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 23/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluation of analgesic effect of Benzydamine Hydrochloride mouthwash after orthodontic premolar extraction. 
Scientific Title of Study   Comparison of clinical efficacy of Benzydamine Hydrochloride oral rinses versus normal saline rinses to satisfy analgesic requirements post orthodontic premolar extraction - A comparative split mouth study. 
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 Nupoor Sanjaykumar Meher 
Designation  Post graduate student 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Pune 
Address  106,Department of Oral and Maxillofacial Surgery, Bharati Vidyapeeth Dental college and Hospital Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  9860721934  
Fax    
Email  nupoormeher@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikrant Sane 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Pune 
Address  106,Department of Oral and Maxillofacial Surgery, Bharati Vidyapeeth Dental college and Hospital Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  9860721934  
Fax    
Email  vikrantsane@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nupoor Sanjaykumar Meher 
Designation  Post graduate student 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Pune 
Address  106,Department of Oral and Maxillofacial Surgery, Bharati Vidyapeeth Dental college and Hospital Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  9860721934  
Fax    
Email  nupoormeher@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Dental College and Hospital, Pune 
 
Primary Sponsor  
Name  Dr. Nupoor Sanjaykumar Meher 
Address  106,Department of Oral and Maxillofacial Surgery, Bharati Vidyapeeth Dental college and Hospital,Pune 
Type of Sponsor  Other [Self] 
 
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 Nupoor Sanjaykumar Meher  Bharati Vidyapeeth Dental College and Hospital, Pune  106, Department of Oral and Maxillofacial Surgery.
Pune
MAHARASHTRA 		 9860721934

nupoormeher@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth deemed to be university Pune India Dental College and Hospital Pune Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Benzydamine Hydrochloride mouthwash  Oral rinses with the mouthwash will be advised 24hrs post extraction 4-6 times a day for 3 daysin study group 
Comparator Agent  Normal Saline  Oral rinses with normal saline will be advised 24hrs post extraction 4-6 times a day for 3 days in control group 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Bilateral premolar extraction advised by Dept of Orthodontics.
2.Extraction site should be free of active infection.
3.Atraumatic extraction.
4.Patient should be free of drug reaction used in our study (allergy).
5.Patient should be free of any co-morbidity.
 
 
ExclusionCriteria 
Details  1.Known mentally challenged patients and patients unable to communicate.
2.Patients with known systemic co-morbidity.
3.Fracture of tooth during extraction.
4.Presence of active infection.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS score maybe lower and satisfaction level may be higher as compared to control group.  Patient will be followed up on 3rd day post extraction 
 
Secondary Outcome  
Outcome  TimePoints 
VAS score maybe lower & satisfaction level may be higher as compared to scores on 3rd day post extraction.  Patient will be followed up on 7th day post extraction 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   14/03/2024 
Date of Study Completion (India) 20/05/2024 
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)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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  

Oral surgeons have been most commonly using oral non-steroidal anti-inflammatory drugs (NSAIDs) to manage postoperative discomfort

However, the use of oral NSAIDs have been associated with numerous gastrointestinal, renal and hematological side effects.

Efficient, safe and topical medications with anti-inflammatory action and minimal side-effects would be a good option for controlling pain after removal of premolars for orthodontic treatments.

Benzydamine hydrochloride {1-benzyl-3-[3(dimethylamino)-propoxy]-1H-indazole hydrochloride} is a non-steroidal drug with anti-inflammatory, analgesic, and anti-microbial properties. It exerts the effect by forming thromboxanes which decreases prostaglandin production.

The aim of this study is to compare the clinical efficacy of Benzydamine Hydrochloride oral rinse with that of normal saline rinses on pain and patient satisfaction after removal of bilateral premolars for orthodontic correction of malocclusion.

Topical NSAID benzydamine hydrochloride may reduce the use of oral analgesic consumption as compared to the use of normal saline gargle. The satisfaction level after using benzydamine hydrochloride would be better as that after using normal saline gargle.

 

 
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