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
|
|
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
|
|
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.4 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.5 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. |