| CTRI Number |
CTRI/2025/08/092560 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Buzzy Bee and Vibradent Devices to Reduce Pain and Anxiety in Children During Dental Injections for Tooth Removal |
|
Scientific Title of Study
|
Comparative evaluation of acceptability feasibility and satisfaction of buzzy bee and vibradent in relieving pain and anxiety during local anaesthesia administration during dental extraction A randomised controlled 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 shajaratul yakeen nabi |
| Designation |
Post graduate resident |
| Affiliation |
Government dental college and hospital srinagar |
| Address |
2nd floor department of pediatric and preventive dentistry govt dental college and hospital shireen bagh srinagar
Srinagar
JAMMU & KASHMIR
190010
India |
| Phone |
9469055328 |
| Fax |
|
| Email |
shajaratulyakeen9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nazia lone |
| Designation |
Professor and Head |
| Affiliation |
Government dental college and hospital srinagar |
| Address |
2nd floor department of pediatric and preventive dentistry govt dental college and hospital shireen bagh srinagar
Srinagar
JAMMU & KASHMIR
190010
India |
| Phone |
9419060028 |
| Fax |
|
| Email |
lonenazia1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shajaratul yakeen nabi |
| Designation |
Post graduate resident |
| Affiliation |
Government dental college and hospital srinagar |
| Address |
2nd floor department of pediatric and preventive dentistry govt dental college and hospital shireen bagh srinagar
Srinagar
JAMMU & KASHMIR
190010
India |
| Phone |
9469055328 |
| Fax |
|
| Email |
shajaratulyakeen9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry, Government dental college and hospital srinagar, Jammu and Kashmir Inida 190010 |
|
|
Primary Sponsor
|
| Name |
Government dental college and hospital srinagar |
| Address |
SHIREEN BAGH SRINAGAR JAMMU AND KASHMIR 190010 |
| Type of Sponsor |
Other [Govt dental college] |
|
|
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 Shajaratul yakeen nabi |
Government dental college and hospital |
2nd floor department of pediatric and preventive dentistry govt dental college and hospital shireen bagh srinagar
Srinagar
JAMMU & KASHMIR |
09469055328
shajaratulyakeen9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMIITTEE GDC&H SRINAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BUZZY BEE |
It is vibrotactile and cryotherapy based device for reducing the pain perception during local anesthesia administration. The intervention duration was approximately 2 to 3 minutes, with the device applied one minute prior to needle insertion and maintained throughout the administration of local anaesthesia. |
| Comparator Agent |
vibradent |
it is a vibrotactile device used to reduce pain perception during local anesthesia administration |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1) Cooperative patients with positive behaviour according to Frankel behaviour rating scale (FBRS).
2) Should be first visit of the patient to the dental clinic.
3) 7 to 10-year-old children.
4) Patient who needs local anaesthesia, either maxillary infiltration or mandibular nerve block for extraction.
5) Free from any psychological and neurological disorder (Autism, Attention deficit hyperactivity disorder).
|
|
| ExclusionCriteria |
| Details |
1) Patients with congenital diseases.
2) Patients with respiratory diseases.
3) Medically compromised patients.
4) Children with significantly altered emotional state.
5) Children unable to quantify pain.
6) No history of drug allergy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Compare vibradent and buzzy bee on reducing pain during LA administration in paediatric dental patients using WBFPS FLACC SEM scales at baseline(T0) at needle insertion(Tn) and three minutes after LA(Te)
2)Compare anxiety levels using FIS Heart rate and salivary cortisol
3) Compare their efficacy between local infiltration and nerve block |
10 minutes Before anaesthesia administration
During anaesthesia administration
10 minutes after anaesthesia administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate parent & patient acceptance & satisfaction using questionnaire.
2) To assess feasibility of the procedure by calculating time required to complete the procedure.
|
10 mins |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="0"
Months="1"
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
|
The purpose of this randomized controlled trial is to compare the acceptability, feasibility, and satisfaction levels associated with the use of two pain and anxiety management devices—Buzzy® and Vibradent—during local anesthesia administration for dental extractions in children. Given the high prevalence of dental fear and anxiety among pediatric patients and the impact it has on treatment outcomes, this study aims to evaluate how these devices can improve the overall dental experience for both children and their caregivers. It is hypothesized that both Buzzy® and Vibradent will be effective in reducing pain and anxiety during local anesthesia administration, but Buzzy® may provide superior results due to its multimodal action (vibration + cryotherapy) compared to vibration-only intervention with Vibradent. Additionally, the study expects higher acceptability and satisfaction from both children and parents with the use of these devices, particularly Buzzy® The primary outcome of the study are: 1)To quantify the effect of vibradent and buzzy bee on reducing pain during local anaesthesia administration in paediatric dental patients using self-report by patient using Wong baker faces pain scale (WBFPS) and observer reported pain assessment using Face Legs Activity Cry Consolability scale(FLACC) and Sound Eye Motor scale(SEM) scales at baseline(T0) at needle insertion(Tn) and three minutes after completion of local anaesthesia administration(Te) 2)To assess and compare anxiety levels at all lines of study using subjective (self-reported anxiety using FIS) and objective parameters using heart rate at T0 Tn and Te. Salivary cortisol levels are checked at T0 and T10 (Ten minutes after needle insertion). 3)To evaluate and compare the efficacy of vibrotactile and vibrotactile with cryotherapy in local infiltration and nerve blocks. |