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CTRI Number  CTRI/2022/01/039457 [Registered on: 14/01/2022] Trial Registered Prospectively
Last Modified On: 14/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of clinical effectiveness of buffered and nonbuffered 4% articaine infiltration for primary maxillary molar extraction. 
Scientific Title of Study   COMPARATIVE EVALUATION OF CLINICAL EFFECTIVENESS OF BUFFERED AND NONBUFFERED 4% ARTICAINE (WITH ADRENALINE 1:100000) INFILTRATION FOR PRIMARY MAXILLARY MOLAR EXTRACTIONS : AN EXPERIMENTAL STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parag Sadashiv Dhake 
Designation  Postgraduate Student 
Affiliation  VSPM DENTAL COLLEGE, NAGPUR 
Address  Dept no- 301, dept of pediatric and preventive dentistry, V.S.P.M. Dental college and Research Centre, digdoh hills, hingna Road, Nagpur Nagpur MAHARASHTRA 440019 India

Nagpur
MAHARASHTRA
431002
India 
Phone  9403410920  
Fax    
Email  dhakeparag6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devendra Nagpal 
Designation  Professor & Head 
Affiliation  VSPM DENTAL COLLEGE, NAGPUR 
Address  Dept no- 301, dept of pediatric and preventive dentistry, V.S.P.M. Dental college and Research Centre, digdoh hills, hingna Road, Nagpur Nagpur MAHARASHTRA 440019 India

Nagpur
MAHARASHTRA
440019
India 
Phone  9764271839  
Fax    
Email  drdevendra19@gmail.com  
 
Details of Contact Person
Public Query  
Name  Parag Sadashiv Dhake 
Designation  Postgraduate Student 
Affiliation  VSPM DENTAL COLLEGE, NAGPUR 
Address  Dept no- 301, dept of pediatric and preventive dentistry, V.S.P.M. Dental college and Research Centre, digdoh hills, hingna Road, Nagpur Nagpur MAHARASHTRA 440019 India

Nagpur
MAHARASHTRA
431002
India 
Phone  9403410920  
Fax    
Email  dhakeparag6@gmail.com  
 
Source of Monetary or Material Support  
V.S.P.M. Dental college and Research Centre, Nagpur 
 
Primary Sponsor  
Name  Dr Parag Sadashiv Dhake 
Address  dept no- 301, dept of pediatric and preventive dentistry, V.S.P.M. Dental college and Research Centre, digdoh hills, hingna Road, Nagpur 
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 Parag Sadashiv Dhake  V.S.P.M. Dental college and Research Centre, Nagpur  dept no- 301, dept of pediatric and preventive dentistry. Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 9403410920

dhakeparag6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Of V.S.P.M. Dental college and Research Centre.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children of 4-10 years of age. Children Having at least one primary maxillary molar indicated for extraction under local anaesthetic. 
Patients  (1) ICD-10 Condition: K027||Dental root caries, (2) ICD-10 Condition: K027||Dental root caries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  4% articaine (with adrenalin 1:100000)  4% articaine (with adrenalin 1:100000) is most frequently used anesthetic agent for infiltration in dentistry. It has an acidic pH leading to burning sensation during administration. 
Intervention  4% Buffered articaine (with adrenalin 1:100000)  buffered articaine increases the pH of commercially available articaine (with adrenalin 1:100000) thus reducing pain during administration of local anesthesia  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children Having at least one primary maxillary molar indicated for extraction
under local anaesthetic.
Children who exhibited Frankl’s behavior rating grade three or four i.e positive
and definitely positive. 
 
ExclusionCriteria 
Details  Children with active infection at the site of injection.
Children with known history of allergy to any local anaesthetic agent.
History of major dental treatment in last 6 months. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate clinical effectiveness of buffered and nonbuffered 4% articaine (with adrenaline
1:100000) infiltration for primary maxillary molar extractions 		 After infiltration anaesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
To compare and evaluate pain on injection of buffered and nonbuffered 4% articaine (with adrenaline 1:100000) infiltration for primary maxillary molar extractions.  During infiltration anaesthesia 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   17/01/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary    The effective control of pain during dental procedures is an important prerequisite of paediatric dentistry. Though local anaesthetic injections trigger pain and anxiety in children, they continue to be used in dental treatment for children’s comfort, cooperation and pain-free treatment.

Articaine is considered a unique local anaesthetic agent and buccal infiltration with articaine can be used to anaesthetize dental tissues for various dental procedures.

Adrenaline is important in local anaesthetic as it prolong the anaesthetic effect. Lower pH of local anaesthetic solution is set for increasing shelf life of adrenaline. Buffered local anaesthetic have been reported to improve anaesthetic onset and success. Systematic review in medicine have shown reduced injection pain with buffered anaesthetics.

Buffering has been reported to enhance the depth and duration of the anaesthetic level without causing untoward effects on the haemostatic properties of adrenaline when it is added to the solution.

The buffering of lidocaine has been widely evaluated in field of medicine. Though lidocaine is gold standard in local anaesthesia, studies have reported articaine to be more or equally effective when compared to lidocaine in infiltration anaesthesia.

The purpose of this study is to evaluate effectiveness of buffered articaine for primary maxillary molar extractions and pain on injection in children. 
 
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