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CTRI Number  CTRI/2023/09/057831 [Registered on: 19/09/2023] Trial Registered Prospectively
Last Modified On: 04/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Pain perception of children during local anesthesia administration using BUZZY SYSTEM and CRYOANESTHESIA - A Randomized Clinical Trial 
Scientific Title of Study   Comparative evaluation of pain perception of children using Buzzy system and Cryoanesthesia - A Randomized 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  Dr Muhammed Anushelque N 
Designation  PG student 
Affiliation  KVG Dental College and Hospital, Sullia 
Address  Department of Pediatric and Preventive Dentistry, P.G Division, Room no 5, Third Floor, KVG Dental College And Hospital, Sullia

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9656028343  
Fax    
Email  anushelque@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishnamoorthy S H 
Designation  Professor 
Affiliation  KVG Dental College and Hospital, Sullia 
Address  Department of Pediatric and Preventive Dentistry, P.G Division, Room no 5, Third Floor, KVG Dental College And Hospital, Sullia

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9656028343  
Fax    
Email  kmoorthysh21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Muhammed Anushelque N 
Designation  PG student 
Affiliation  KVG Dental College and Hospital, Sullia 
Address  Department of Pediatric and Preventive Dentistry, P.G Division, Room no 5, Third Floor, KVG Dental College And Hospital, Sullia

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9656028343  
Fax    
Email  anushelque@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, P.G Division, Room no 5, Third Floor, KVG Dental College And Hospital, Sullia, Dakshina Kannada, Karnataka - 574327 
 
Primary Sponsor  
Name  Dr Muhammed Anushelque N 
Address  Department of Pediatric and Preventive Dentistry, P.G Division, Room no 5, Third Floor, KVG Dental College And Hospital, Sullia 
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 Muhammed Anushelque N  KVG Dental College And Hospital, Sullia  Department of Pediatric and Preventive Dentistry.
Dakshina Kannada
KARNATAKA 
9656028343

anushelque@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe KVG Dental College and Hospital, Sulliae   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BUZZY BEE  BUZZY BEE After being seated in a dental chair, children are initially introduced to the device by demonstrating its function in simple words; next, the child is allowed to play with the BuzzyⓇ for familiarization purposes. The device is then connected to the frozen wing; BuzzyⓇ is placed extra-orally above the cheek region where the LA is to be administered. Intervention is till the Local anesthesia is given  
Comparator Agent  CRYOANESTHESIA  CRYOANESTHESIA After being seated in a dental chair, children are initially introduced and explained about the procedure of placing the ice to where the LA is to be administered. Then an ice cube is kept over the site of LA administration for 60 seconds. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Children requiring bilateral inferior alveolar nerve block administration.

2.Children classified as OUTWARDLY APPREHENSIVE and FEARFULL according to Lampshire’s classification of child’s behavior.

3.Children with parental consent.
 
 
ExclusionCriteria 
Details  1.Children with previous experience of LA administration.
2.Children with systemic illness.
3.Children with special health care needs / differently abled.
4.Children who are medically compromised.
5.Children who are allergic to local anesthetic agents.
6.Signs of inflammation or infection at the injection site
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
For Outcome, we are considering null hypothesis as true. That is, there is no difference in the perception of pain either using buzzy system or cryoanesthesia during the administration of local anesthesia. Which will be assessed using Sound eye motor scale and acceptance using Wong- Baker faces pain rating scale.  1. Just before Procedure
2. During Procedure
3. Immediately after procedure 
 
Secondary Outcome  
Outcome  TimePoints 
NONE  NONE 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   10/10/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Pain according to World Health Organization’s definition is “an unpleasant sensory or emotional experience associated with actual or potential tissue damage”.  Pain is an unavoidable part of dental procedures, and it is one of the leading causes of dental phobia in youngsters. Fear and anxiety-related behaviour, particularly during dental treatments, can be a substantial hindrance to dental care and can have a negative influence on a child’s overall oral health and well-being. The foundation of a good behaviour management programme is effective pain control in a pediatric patient during dental treatment, which is primarily accomplished with local anesthetic medications. In pediatric dental care, pain management is a significant part of anxiety, which is often related to the induction of pain and exacerbates pain perception. As a result, these individuals experience higher pain, which lasts longer and is associated with exaggerated pain memory. (1) According to Bienvenu and Eaton, children with needle phobia experienced unpleasant needle insertion in the past. (2) As a result, children may sense varying levels of pain from the same stimuli (e.g., dental injection). Okawa et al. suggested that children reported elevated dental pain when they were highly anxious. (3) Hmud and Walsh (2009) identified the "4S factors" for children’s dental anxiety; these include sights (e.g., feeling of uneasiness and worry), sounds (eg., of drilling), sensations (high-frequency vibrations), and smells (odors of eugenol and bonding agents). (4) According to Rachman, conditioning (direct response), modeling, and information (indirect responses) are three factors promoting dental anxiety in children. (5) Extreme pain can cause short-term or long-term physiological, psychological, and emotional consequences.  Administration of Local anesthesia (LA) is a common method for relieving dental discomfort associated with invasive treatments, such as tooth extractions and surgeries, although it can also be associated with non-invasive procedures, they are the safest and most effective drugs for pain prevention and management among all medicines nevertheless, needle-related procedures are common sources of fear and anxiety in youngsters, who have a natural aversion to sharp and pointed objects. (6) Prevention of pain can promote a positive relationship between the dentist and child, build trust, allay fear and anxiety, and inculcate positive dental attitudes for future treatment. (7) Even in children too young to speak, fear of pain is not frivolous: the consequences of untreated pain have an impact on medical outcomes and are recalled by preverbal children. (8) Inadequate pain management encourages negative responses and fear in children, making it difficult for dentists to instils a positive attitude in pediatric patients. As a result, every pediatric dentist’s main goal has become to treat children with the least amount of distress and pain possible. Hence developing strategies to reduce pain during injections is critical in preventing patients from postponing dental care. (9) To achieve a healthy child-dentist relationship, alleviate fear and anxiety, create trust and rapport, and instils a positive dental attitude for future consultations, it is critical to focus the child’s attention on the treatment and target their cognitive abilities. Basis of successful behaviour guidance is the effective management of pain in children during dental appointments. (10) Gold standard interventions for managing children experiencing needle-related pain is the Non-pharmacological behaviour guidance techniques.

                     Following are the Different non-pharmacological behaviour guidance techniques reported in the different literature including the: Tell-Show-Do (TSD), voice control, modeling, acupuncture, biofeedback, hypnosis, guided imagery, and distraction using storytelling, audio, or audio-visual aids, which target the psychological facet of the child; these are highly acceptable, as they do not result in repercussions. (11,12) Distraction is the process of diverting a child’s attention away from an unpleasant stimulus during dental operations. Distraction is a simple and inexpensive technique that cuts down on the amount of time and staff needed to complete the treatment.

             Pre-cooling the injection site is one such option for reducing injection pain. Cold stimulation of the injection site prior to LA administration is a simple and physiologically successful treatment with no additional expenditures. (13) The use of gels in cold temperatures as a supplement to a vibrating device has recently shown promise. These vibrating devices are expected to create a distracting environment that will stimulate brain cells to transmit the vibrations, allowing the anesthetic to be given. The justification for employing both cold (temperature) and vibration (stimulation) is based on the idea that pain is a psychological component that requires the patient’s attention and observation. (14) Despite advancements in pediatric dentistry, injections continue to be a cause of discomfort and anxiety; unfortunately, no standard injection technique has so far been created.

                     The Buzzy system is a bee-shaped device with two parts: a bee’s body vibration and removable ice wings. Melzack and Wall’s (1965) gate control theory of pain and the descending inhibitory mechanism are the foundations of the Buzzy system. More specifically, the buzzy body’s vibration will block the afferent pain-receptive fibres (A-delta and C fibres), resulting in pain reduction. (15) Furthermore, when a prolonged cold treatment (30-60 seconds) is applied closer to the nociception site, the c-nociceptive fibres are activated, and the A-delta pain transmission signal is further blocked. (16)

                               Cryoanesthesia is the application of cold to a confined body part using refrigerant sprays or ice to prevent pain impulses from being transmitted by nerves. (17) Cold applied topically thereby excites myelinated A-fibers and stimulates inhibitory pain pathways. (17)  Cooling causes neuropraxia by reducing the tissue nociceptors threshold as well as the pain-carrying conduction nerve signals. (18) Precooling the soft tissue area reduces pain perception for infiltrations and block anesthesia in children during routine dental operations, according to Bose et al. (19) In a systematic review, Tirupathi and Rajasekhar found that precooling with ice lowers pain more than refrigerant spray before local anesthetic application. (20) Very few studies have been undertaken to evaluate the Buzzy® device’s efficacy in administering local anesthetic (LA) for dental procedures in pediatric patients since its invention. And there are hardly any studies been conducted to compare the efficacy of Buzzy® device with cryoanesthesia.

             Thus, the purpose of this study is to determine the efficacy of a local anesthetic procedure using the Buzzy system versus cryoanesthesia for pain relief in children receiving local anesthesia injections, as well as to compare pain perception and patient comfort between the Buzzy system and Cryoanesthesia.

 
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