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CTRI Number  CTRI/2022/01/039554 [Registered on: 19/01/2022] Trial Registered Prospectively
Last Modified On: 03/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of conventional syringe, insulin syringe and deception needle in reduction of anxiety and pain during administration of local anaesthesia in children 
Scientific Title of Study   Comparative evaluation of anxiety levels and pain perception during local anaesthesia administration using conventional syringe, insulin syringe and deception needle in 6–12 year-old children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Kohli 
Designation  Post graduate Student 
Affiliation  KAHERs KLE VK Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry,KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  7309193393  
Fax    
Email  nehakohli103.nk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivayogi M Hugar 
Designation  Professor and Head 
Affiliation  KAHERs KLE VK Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campus, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9986436448  
Fax    
Email  dr.hugarsm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivayogi M Hugar 
Designation  Professor and Head 
Affiliation  KAHERs KLE VK Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campus, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9986436448  
Fax    
Email  dr.hugarsm@gmail.com  
 
Source of Monetary or Material Support  
KLE VK Institute of Dental Sciences, Belagavi 
 
Primary Sponsor  
Name  Department of Pediatric and Preventive Dentistry 
Address  KAHERs KLE VK Institute of Dental Sciences, Belagavi 
Type of Sponsor  Research institution and hospital 
 
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 Neha Kohli  Department No.6,Department of Pediatric and Preventive Dentistry  KAHERs KLE VK Institute of Dental sciences, JNMC Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 
7309193393

nehakohli103.nk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee KLE VK Institute of Dental Sciences Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F419||Anxiety disorder, unspecified, (2) ICD-10 Condition: K040||Pulpitis, (3) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Syringe  The syringe will be preloaded with 2% lignocaine with 1: 80,000 adrenaline. Topical anaesthetic shall be applied at the site of delivery. The child will be told that the tooth will be “going to sleep” after administration of magic water. The preloaded syringe will be used to deliver the local anaesthetic at the site of delivery by a trained Pediatric dentist. Pulse rate will be recorded after the procedure. The child will be given Venham Picture Scale after the local anaesthetic delivery for assessment of anxiety. To record the perception of pain, the patient will be made to record pain perception using Wong Baker Faces Pain Rating Scale. Total duration of the therapy would be 30 minutes.  
Intervention  Deception Syringe  A conventional syringe will be preloaded with 2% lignocaine with 1: 80,000 adrenaline and will be kept out of sight of patient. Patient will be shown a disposable obturation tip on conventional syringe and will be allowed to feel the tip. Topical anaesthetic will be applied at the site of delivery. The child will be told that the tooth will be “going to sleep” after administration of magic water using the same disposable tip as shown before. The preloaded conventional syringe will be used to deliver the local anaesthetic at the site of delivery by a trained paediatric dentist by ensuring to keep it out of sight of the patient. Pulse rate will be recorded after the procedure. The child will be given Venham Picture Scale after the local anaesthetic delivery for assessment of anxiety. To record the perception of pain, the patient will be made to record pain perception using Wong Baker Faces Pain Rating Scale. Further treatment will be continued for the offending tooth by the Principal Operator. Total duration of the therapy would be 30 minutes.  
Intervention  Insulin Syringe  The syringe will be the preloaded with 2% lignocaine with 1: 80,000 adrenaline. Topical anaesthetic will be applied at the site of delivery. The child will be told that the tooth will be “going to sleep” after administration of magic water. The preloaded insulin syringe will be used to deliver the local anaesthetic at the site of delivery by a trained Pediatric dentist. Pulse rate will be recorded after the procedure. The child will be given Venham Picture Scale after the local anaesthetic delivery for assessment of anxiety. To record the perception of pain, the patient will be made to record pain perception using Wong Baker Faces Pain Rating Scale. Total duration of the therapy would be 30 minutes.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children between the age group of 6-12 years.
2. Children who require infiltration anaesthesia in the maxillary arch for restorative, pulp therapy or extraction work.
3. Children who have never experienced dental injection.
4. Patients who are willing to undergo treatment.
 
 
ExclusionCriteria 
Details  1. Children with systemic diseases and special health care needs.
2. Patients allergic to contents of local anaesthesia.
3. Patients who require emergency treatment.
 
 
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 Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Anxiety Levels  Pre and Post Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Pain Perception  Post Intervention 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/01/2022 
Date of Study Completion (India) 31/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

A child’s emotional and behavioral response to dental treatment has been a matter of concern for pediatric dentists since decades. Child’s uncooperative or unmanageable behavior can impede the efficient delivery of dental care and can compromise the quality of treatment being rendered. If not adequately resolved, a persistent negative behavior pattern can hamper the future dental health of a child. A vicious cycle can be observed in relation to dental fear and anxiety wherein fear directly leads to avoidance of dental visits which results in detrition of oral health, which further leads to a more problem oriented dental visit and exacerbation of the level of dental fear.1 Hence, presence of dental fear and anxiety can be a major obstacle in the delivery of quality dental services.

 

Dentistry as a branch has an environment which can elicit anxiety in children. Various studies have concluded that injections are one of the most fear-provoking stimuli in dentistry.2,3 This also pertains to the fact that children are exposed to injections a multiple number of times since they undergo vaccinations from infancy to childhood. However, a profound local anesthesia ensures a successful treatment of pediatric patients in terms of alleviating their anxiety and discomfort during restorative and surgical procedures.Due to its ample use in the field of paediatric dentistry, a painless administration of injection would in turn lead to good behavior from the patient in the future.

 

The application of local anaesthesia has always been a difficult task since children perceive it to be threatening both visually and psychologically. Thus, an anxious patient might perceive more severe pain of longer duration than would a less anxious patients.In an attempt to improve patient comfort during local anaesthetic administration, use of topical agents, precooling the injection site, use of fine needles, buffering and warming the local anaesthesia, distraction techniques, vibrating devices and slow computer-regulated administration are some of the widely used techniques. 

 

One of the most convenient practice is to use an insulin syringe which is smaller in size, colourful, and less frightening than the usual conventional syringes. Another alternative method can be masking the conventional needle by showing children disposable plastic tips before the administration and eventually using the conventional needles by keeping them hidden from their sight. 

When literature search was carried out, it showed that few studies have been conducted which compared the conventional syringes with insulin syringes. However, no study has been conducted which involves the use of a deception needle by showing the patient disposable obturation tips and eventually using the conventional syringe for administration of Local anaesthesia. Hence, this study was planned to evaluate the anxiety levels and pain perception in children during local anaesthesia administration by comparing conventional syringe, insulin syringe and deception needle.

 
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