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
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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 |
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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 |
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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
|
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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 |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
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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 |
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Secondary Outcome
|
Outcome |
TimePoints |
NONE |
NONE |
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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
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Brief Summary
|
Pain according to World
Health Organization’s definition is “an unpleasant sensory or emotional
experience associated with actual or potential tissue damageâ€. 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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