| CTRI Number |
CTRI/2025/05/087891 [Registered on: 29/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Behavioral
Other (Specify) [cryotherapy with endo ice sticks and using biovibe denta patch] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing pain perception during local anesthesia administration using a novel vibratory patch and cryotherapy. |
|
Scientific Title of Study
|
Comparative analysis of pain perception during administration of local anesthesia using a novel device |
| 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 Aishley Jain |
| Designation |
Post Graduate Student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Shree Guru Gobind Singh Tricentenary University, SGT Dental College, Hospital and Research Institute, B Block, Room No. 204, Budhera, Gurugram-Badli Road, Gurugram, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
9818712707 |
| Fax |
|
| Email |
aishley34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Drishti Palwankar |
| Designation |
Assistant Professor |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Shree Guru Gobind Singh Tricentenary University, SGT Dental College, Hospital and Research Institute, B Block, Room No. 204, Budhera, Gurugram-Badli Road, Gurugram, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
8447570200 |
| Fax |
|
| Email |
drishti_fds@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Drishti Palwankar |
| Designation |
Assistant Professor |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Shree Guru Gobind Singh Tricentenary University, SGT Dental College, Hospital and Research Institute, B Block, Room No. 204, Budhera, Gurugram-Badli Road, Gurugram, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
8447570200 |
| Fax |
|
| Email |
drishti_fds@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shree Guru Gobind Singh Tricentenary University |
| Address |
B Block, Faculty of Dental Sciences, Room No. 204, Dept. of conservative Dentistry and Endodontics, Budhera, Gurugram-Badli Road, Gurugram, Haryana, India
pincode: 122505 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aishley Jain |
Shree Guru Gobind Singh Tricentenary University |
B Block, Faculty of Dental Sciences, Room No. 204, Budhera, Gurugram-Badli Road, Gurugram, Haryana, India
Gurgaon
HARYANA |
09818712707
aishley34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- SGT Dental College, Hospital and Research Institute (IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lignocaine with 1:100,000 epinephrine (ICPA Xicaine, India) |
The anesthetic solution will be injected with an aspiration-type syringe with a 21-mm, 27-gauge needle. 1.8 mL solution will be deposited at rate of 1mm/minute |
| Intervention |
BioVibe- DentaPatch (BVDP) |
The BVDP will be selected according to the size of the tissue in the target area. After palpation, dry the target area using sterile cotton and mark the site of needle insertion using H&E pencil. The cover of adhesive from the patch will be removed gently and it will be placed in the oral cavity at the target area such that the hole in the BVDP and the marking of H&E pencil coincide. The motor component (which will regulate the vibration and has batteries) will be attached to the vibratory coin assembly. ON button will be pressed and the vibrations will be produced. time: 2 minutes |
| Intervention |
Endo Ice Stick for cryotherapy |
An ice pretreatment of the soft tissue of the injection site will carried out using a tube of ice for one minute. The ice tubes will be prepared by filling water in tube-shaped plastic containers. A wooden stick will be inserted in each tube so that after freezing it can be held in hand and utilized for this study. The water-filled containers will be frozen at a temperature of -4ºC. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient aged 18 years and above
2. Patients who require local anesthetic injections prior dental procedure
3. Patients who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with systemic medical conditions
2. Patients with problems in comprehension
3. Patients allergic to local anesthetic agents |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of pain perception using BioVibe-DentaPatch (BVDP) - a novel device during administration of local anesthesia. |
degree of pain during the local anesthetic injections using Visual Analog Scale (VAS) will be recorded within five minutes of application. outcome will be assessed at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the pain perception during administration of local anesthesia with and without BioVibe-DentaPatch (BVDP) - a novel device in patients undergoing dental procedures |
degree of pain during the local anesthetic injections using Visual Analog Scale (VAS) will be recorded within five minutes of application |
| pain perception using coolant & BioVibe-DentaPatch (BVDP)- a novel device during administration of local anesthesia in patients undergoing dental procedures. |
degree of pain during the local anesthetic injections using Visual Analog Scale (VAS) will be recorded within five minutes of application. outcome will be assessed at baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Introduction: Dental anxiety and fear of needles hinder timely
treatment, with intraoral injections being a major source of pain and
discomfort. Pain perception varies
based on factors like injection site and patient sensitivity among kids and
adults.Traditional pain management methods include topical anesthetics and slow
injection techniques, while non-pharmacological
strategies like vibratory stimulation offer promising alternatives.Vibratory devices such as DentalVibe and VibraJect reduce
injection pain via the Gate Control Theory. However, no bioadhesive
vibrating patch exists yet. The study aims to evaluate BioVibe-DentaPatch (BVDP), a novel vibratory patch, in reducing
injection pain in adults using the Visual Analogue Scale (VAS).ooh
Objectives: 1. To evaluate the effect
of pain perception using BioVibe-DentaPatch (BVDP) -
a novel device during administration of local anesthesia.
2. To compare the pain
perception during administration of local anesthesia with and
without BioVibe-DentaPatch (BVDP) -
a novel device in patients undergoing dental procedures.
3.To evaluate and compare the pain
perception using coolant and BioVibe-DentaPatch (BVDP)- a novel
device during administration of local anesthesia in
patients undergoing dental procedures.
Materials and methodology:
1.Endo Ice
sticks
2.2% lignocaine with 1: 100,000
epinephrine (ICPA Xicaine, India)
3. 21-mm
aspirating type syringe, 27-gauge needle (Dispovan)
4.BioVibe- DentaPatch (BVDP)
A sample
size of 100 patients will be
chosen as per inclusion criteria. The subjects will be from the Department of
Conservative Dentistry and Endodontics, Faculty
of Dental Scienes, SGT
Dental College, Gurugram. They
are then divided into 2 groups- 50 patients per group.
Group A- local anesthesia
administration without BVDP
Group B- local anesthesia
administration with BVDP
Subgroup b1: local anesthesia
administration with BVDP but without cryotherapy (ie.,
without use of coolant) n=25
Subgroup b2: local anesthesia
administration with BVDP and cryotherapy (ie., use of
coolant) n=25 |