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CTRI Number  CTRI/2025/10/095883 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 10/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparative Evaluation of Warm, Buffered Articaine and Buffered Articaine for buccal infiltration of Primary tooth for Pulp therapy procedures: A split mouth design clinical trial. 
Scientific Title of Study   Comparative evaluation of warm, buffered articaine vs buffered articaine for buccal infiltration of primary tooth for pulp therapy procedures: a split mouth design clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devadhakshayani V 
Designation  Post Graduate 
Affiliation  Vinayaka missions sankarachariyar dental college 
Address  Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road,Ariyanoor

Salem
TAMIL NADU
636308
India 
Phone  9791997480  
Fax    
Email  devadhakshayani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrVeena Arali 
Designation  Professor and HOD 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road, Ariyanoor

Salem
TAMIL NADU
636308
India 
Phone  8355803238  
Fax    
Email  empendurkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrVeena Arali 
Designation  Professor and HOD 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road, Ariyanoor

Salem
TAMIL NADU
636308
India 
Phone  8355803238  
Fax    
Email  empendurkar@gmail.com  
 
Source of Monetary or Material Support  
Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road, Ariyanoor 
 
Primary Sponsor  
Name  Devadhakshayani V 
Address  Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road,Ariyanoor 
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 
Devadhakshayani V  Vinyaka Missions Sankarachariyar Dental College  Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road, Ariyanoor
Salem
TAMIL NADU 
9791997480

devadhakshayani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee of VMS Dental College Salem  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  DENTAL TREATMENT 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Buffered articaine  1.8 ml 0f Articaine will be taken 0.18 ml will be taken out and 0.18 ml of sodium bicarbonate will be added and will be given as buccal infiltration for one time for 1minute 
Intervention  warm buffered articaine  1.8 ml 0f Articaine will be taken 0.18 ml will be taken out and 0.18 ml of sodium bicarbonate will be added and the buffered articaine will be warmed using baby bottle warmer and will be given as buccal infiltration for one time for 1minute 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children exhibiting Frankel’s behavior rating of grade 3 and 4 (Positive and Definitely Positive)
Children with bilateral deep caries with pulpal exposure
Class I and class II relying on ASA classification
 
 
ExclusionCriteria 
Details  Considerable behavior problems
Children with systemic conditions
Parents who refuse to participate in the study
 
 
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 Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Identify which method of Local Anesthetic administration is less painful using Wong bakers pain scale at baseline  Before Administration Of LA
during Administration of LA
At baseline after administration of LA 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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   Phase 4 
Date of First Enrollment (India)   24/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Pain management is an extremely important step in behaviour management of   children in pediatric dental practice. Local anesthesia (LA) is the transient loss of sensation in a specific area of the body caused by the depression of nerve ending excitation or inhibition of conduction in the peripheral nerves. Although local anesthetic injections cause pain and anxiety in children, they are an integral part of dental treatment for comfortable, cooperative, and pain-free dental treatment. The site and speed of injection and the pH of the anesthetic solution have all been linked to pain during LA administration. Various techniques have been suggested to alleviate pain during injection. Warming the local anaesthetic solution to a body temperature found to be effectively reducing pain during dental procedures.

    Another technique to reduce pain is neutralization of the pH of a LA solution by buffering with sodium bicarbonate immediately before injection which also shortens the onset time and improve the clinical efficacy of LAs. While lidocaine has been the gold standard local analgesia for past many years there are other effective agents like articaine has become increasingly popular in dentistry. Articaine hydrochloride is an amide type of local analgesia. It acts in similar way to other amide analgesia but its unique chemical structure offers advantages over traditional amide analgesia’s. Articaine is the only amide analgesia’s to contain an ester group and this allows it to be rapidly broken down to its inactive state thus decreasing systemic toxicity. Articaine is more lipid soluble and more potent thereby enabling it to diffuse more readily through both hard and soft tissues, making it 1.5times more potent than lidocaine.

   Articaine 4% 1:100,000 is reported to be well tolerated, safe and effective local analgesia for use in children. A literature search found that no studies have been conducted on the comparison of buffered and warmed articaine with buffered articaine. The aim of this study is to evaluate and compare the efficacy of warm and buffered articaine with buffered articaine in the pulp therapy of a primary teeth.

AIM To determine the anesthetic effect of warm and buffered articaine with buffered articaine in pulp therapy of a primary teeth

 

    OBJECTIVES To evaluate the anesthetic effect of buffered and warmed articaine in pulp therapy of a primary teeth

To evaluate the anesthetic effect of buffered articaine in pulp therapy of a primary teeth

To compare the anesthetic effect of buffered and warmed articaine versus buffered articaine in pulp therapy of a primary teeth.

METHOD

Study design: Clinical comparative study                                                    

Hypothesis: There is no difference between the anesthetic effect of warm and buffered articaine and buffered articaine in pulp therapy of a primary teeth.

Sample size: 34 Children

Source of study: Children coming to the Department of Pediatric and Preventive Dentistry, VMSDC, Salem.

Duration: 6 months (after ethical committee clearance)

Study population: A total of 34 children between 6-10 years will be included in this study.

Inclusion criteria

    Children aged 6-10  years

Children exhibiting Frankel’s behavior rating of grade 3 and 4 (Positive and Definitely Positive)

Children with bilateral deep caries with pulpal exposure

Class I and class II relying on ASA classification

Exclusion Criteria

Considerable behavior problems

Children with systemic conditions

Parents who refuse to participate in the study.

Randomization

An informed consent from the parent visiting the Department of Pediatric and Preventive Dentistry, VMSDC, Salem will be obtained. The study participants will be allocated by simple randomization.

Methodology

             Participants requiring bilateral pulpotomy and pulpectomy procedures will be selected. On the first visit the children will be subjected to a thorough dental checkup, and radiographs of the offending teeth will be taken. Children with primary teeth on both right and left sides affected with deep dentinal caries, requiring pulp therapy will be selected for the study.

      Wong Bakers Faces Pain Scale will be shown to the children and make them familiarized with it.

     In the first appointment one side of the mouth will be administered with a buccal infiltration of warm and buffered articaine and the pain will be assessed by using Wong Bakers Faces Pain Scale. The physiological parameters such as pulse and heart rate will be recorded using a pulse oximeter.

    In the second appointment after a week the other side of the mouth will be administered with a buccal infiltration of buffered articaine and the pain will be assessed by using Wong Bakers Faces Pain Scale.

    In order to make a buffered solution 1.7 ml cartridge of 4% articaine with 1:100000 adrenaline will be used, from which 0.2 ml of anaesthetic solution will be taken out and it will be replaced with 0.2ml of 8.4% sodium bicarbonate. The ratio between the dental local anaesthetic and 8.4% sodium bicarbonate will be 9:1.

    Warming of the local anaesthetic solution will be done by thermostatic heat bath or baby bottle warmer.

     Buccal infiltration of articaine will be given 

 


 
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