| CTRI Number |
CTRI/2023/07/055708 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial for comparing pain alleviating methods to releive anxiety and pain levels in children during local anesthesia injection for dental treatments. |
|
Scientific Title of Study
|
A comparative evaluation of pain perception and anxiety levels in children during local anesthesia procedure using intraoral and extraoral vibratory systems and conventional local anesthesia with topical anesthestic gel. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamilla Sai Geeta |
| Designation |
Post Graduate Student |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Department of Paediatric and Preventive Dentistry, Sri Sai College of Dental Surgery,
1-2-64/1&2,Kothrepally,Opposite Shiv sagar lake,Vikarabad,Telangana - 501102
Hyderabad
TELANGANA
501102
India |
| Phone |
9626473737 |
| Fax |
|
| Email |
mamillageeta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarada Penmetcha |
| Designation |
Professor |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Department of Paediatric and Preventive Dentistry Sri Sai College of Dental Surgery,
1-2-64/1&2,Kothrepally,Opposite Shiv sagar lake,Vikarabad,Telangana - 501102
Hyderabad
TELANGANA
501102
India |
| Phone |
8008116618 |
| Fax |
|
| Email |
drsarada9@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSarada Penmetcha |
| Designation |
Professor |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Department of Paediatric and Preventive Dentistry, Sri Sai College of Dental Surgery,
1-2-64/1&2,Kothrepally,Opposite Shiv sagar lake,Vikarabad,Telangana - 501102
Hyderabad
TELANGANA
501102
India |
| Phone |
8008116618 |
| Fax |
|
| Email |
drsarada9@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRI SAI COLLEGE OF DENTAL SURGERY
Department of Peadiatric and Preventive Dentistry, 1-2-64/1&2, Kothrepally, Opposite shiv sagar lake, Vikarabad, Telangana 501102 |
|
|
Primary Sponsor
|
| Name |
Mamilla Sai Geeta |
| Address |
Sri Sai College of Dental Surgery,1-2-64/1&2,Kothrepally,opposite shiv sagar lake,vikarabad,telangana - 501102 |
| Type of Sponsor |
Other [self] |
|
|
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 M Sai Geeta |
SRI SAI COLLEGE OF DENTAL SURGERY |
Department of Paediatric and Preventuve Dentistry, Room no.9,1-2-64/1&2,Kothrepally,Opposite Shiv sagar lake,Vikarabad,Telangana-501102
Hyderabad
TELANGANA |
9247873766
mamillageeta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE 2021-22 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children requiring dental treatments |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Conventional topical spray
|
Application of conventional topical lignocaine spray for 30 seconds as a pain alleviating method during local anesthesia procedure |
| Intervention |
extraoral vibratory system |
Application of buzzy system for 30 seconds as a pain alleviating method during local anesthesia procedure. |
| Intervention |
Intraoral vibratory system |
Application of ultrasonic toothbrush for 30 seconds as a pain alleviating method during local anesthesia procedure. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children with no systemic illness
Children experiencing chronic dental pain
Patients requiring LA administration for dental treatment
Children with informed parental consent |
|
| ExclusionCriteria |
| Details |
Children with known systemic disease
Children without parental consent
Children with acute dental pain |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate pain perception & anxiety levels during local anesthesia administration with conventional technique, intraoral technique and extraoral technique. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
19/08/2023 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is defined as an unpleasant sensory or emotional experience associated with actual or potential tissue damage or described in terms of such damage. An important reason for avoidance of dental procedures in children is needle phobia, defined as an extreme fear and anxiety associated with needles. Children with needle phobia are at risk of presenting fear of healthcare professionals and experience higher levels of pain and fear during dental procedures. To alleviate the pain and fear associated with the needle prick several topical anesthetics like ointments, anesthetic sprays, gels, or adhesive patch are recommended. Other methods like application of cold stimuli on the injection site before local anesthesia (LA) administration were also commonly used as an easy and physiologically effective procedure without any surplus costs. It has been advocated that the cold element might confuse the pain pathway’s reception of signals, allowing for a "masking effect of pain." In addition to the above-mentioned methods other systems like vibrators are used to reduce the pain associated with local anesthetic injection. The present study is to compare the efficacy of intraoral and extraoral vibratory systems and conventional local anesthesia with topical anesthetic gel to evaluate pain perception and anxiety levels in children. |