| CTRI Number |
CTRI/2024/02/062675 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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Compare pain experience and dental anxiety in children undergoing injections la through two different methods and devices
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Scientific Title of Study
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Pain perception during local anestheisa administration using computer controlled local anesthesia delivery system Star Pen and Buzzy system in pediatric dental procedures a- Randomised Clinical Trial.
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| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D K Lekha |
| Designation |
Post Graduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive Dentistry
Room Number 7
Division -7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra Pradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9566896875 |
| Fax |
|
| Email |
dklekha.99@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Sivakumar Nuvvula |
| Designation |
Professor and Head |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive Dentistry
Room Number 7
Division -7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra Pradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441624429 |
| Fax |
|
| Email |
dentist4kids@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr K V Saikiran |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive Dentistry
Room Number 7
Division -7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra Pradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8125774535 |
| Fax |
|
| Email |
saikiran4u2008@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Paediatric and Preventive Dentistry
Room Number 7
Division -7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra Pradesh |
|
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Primary Sponsor
|
| Name |
Dr. D K Lekha |
| Address |
Narayana Dental College and Hospital,
Chinthareddypalem
Nellore |
| Type of Sponsor |
Other [Self sponsor] |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D K Lekha |
Narayana Dental College and Hospital |
Division-7 Department of Paediatric and Preventive Dentistry Nellore
Nellore
ANDHRA PRADESH |
9566896875
dklekha.99@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Dental College and Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Buzzy Device |
Device will be connected to the frozen wing cool pad and placed extra-orally above the cheek region, where the LA of 1.8 mL of 2% lidocaine with 1:80,000 adrenaline (LIGNOX) will be administered using Conventional method for 2 minutes |
| Intervention |
Star Pen intra oral local anesthesia device |
After topical application of LA using anesthetic spray , the infiltration will be given using a computerized-controlled local anesthetic device (the star pen), using 2 % lignocaine with 1:80,000 adrenaline which has an algorithm control with constant pressure feedback technology for 2 minutes for extraction and pulpectomy procedure |
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Inclusion Criteria
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| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in the range of 4-9 years
2. The requirement of local anesthetic administration in the maxilla and mandible for pulp therapies and extraction of primary teeth
3. Children who had no prior experience with local anesthesia administration
4. Children who gave their permission and whose parents provided a written informed consent
5. According to the Frankl behavior rating scale, children who fall under positive and negative categories
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| ExclusionCriteria |
| Details |
1. Children with any systemic diseases and mental illness
2. Children with any previous dental pain or problems entailing emergency dental treatments
3. Children who are not willing to participate in the study
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
To compare and evaluate pain perception during local anaesthesia administration using a computer controlled local anaesthesia delivery system Star Pen and the Buzzy system in paediatric dental procedures
|
Pain perception in both groups will be recorded using the Memoji Pain Scale immediately after the injection |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| To determine and compare the dental anxiety in children undergoing local anesthetic administration in the Star pen and the Buzzy system |
Anxiety will be recorded using the RMS pictorial scale before, during and after injection |
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Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 1/ Phase 2 |
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Date of First Enrollment (India)
|
01/03/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Pain is a complex, multidimensional concept that can vary in quality, intensity, duration, location, and unpleasantness. Moreover, the ideas of pain pertinent to children differ from those applicable to adults, possibly due to different cognitive development levels. In dentistry, the most common way to relieve this pain is through local anaesthesia (LA). In particular, needle-related procedures are significant sources of fear and anxiety in children. Extreme pain could result in short or long-term physiological, psychological, and emotional outcomes, especially after a needle experience during the first dental visit, which will adversely impact the child’s overall oral health and well-being. Various techniques have been attempted to effectively control the pain during injection, such as buffering, warming, and adjusting the rate of local anaesthetic infiltration; application of topical anaesthetic vibration using modern devices like Dental Vibe and VibraJect and use of a computer-controlled anaesthetic delivery system. However, these advanced techniques involve a high cost. Despite dental advancements, pain and anxiety continue to be problems with injections. However, no standard injection method has been established. Hence, the present study was planned to compare and evaluate pain perception during local anaesthesia administration using a computer-controlled local anaesthesia delivery system Star Pen and the Buzzy system in paediatric dental procedures. Aim To compare and evaluate pain perception during local anaesthesia administration using a computer-controlled local anaesthesia delivery system Star Pen and the Buzzy system in paediatric dental procedures Objectives 1. To compare the pain experience in children undergoing local anaesthetic administration in the Buzzy and Star pen groups. 2.To determine and compare the dental anxiety in children undergoing local anaesthetic administration in the Buzzy and Star pen groups.
The randomised clinical trial will be done with 118 children in the Department of Paediatric and Preventive Dentistry at Narayana Dental College and Hospital in Nellore. Informed consent will be obtained from the parents of the children who are willing to participate in the study. Children between the ages of 4 and 9 who require pulpectomy and extraction and need local infiltration will be randomly split into two groups. Group 1 Buzzy device, and Group 2 Star Pen with 59 children in each group. After that, the area to be injected will be anaesthetized by applying 2% lignocaine hydrochloride topical gel for 15 to 20 sec. In Group 1, the children were initially introduced to the device by demonstrating its function in simple words; next, the child will be allowed to play with the Buzzy for familiarisation with the device. Later, the device will be connected to the frozen wing and placed extra orally above the cheek region, where the LA of 1.8 mL of 2% lidocaine with 1:100,000 adrenaline will be administered using manual injection. Whereas, in group 2, after topical application of LA, the infiltration will be given using a computerised controlled local anaesthetic device the star pen, which has an algorithm control with constant pressure feedback technology. Finally, pain perception in both groups will be recorded using the Memoji Pain Scale immediately after the injection. Anxiety will be recorded using the RMS pictorial scale. Physiological parameters will be recorded using a pulse oximeter before, during, and after LA administration.
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