| CTRI Number |
CTRI/2025/11/097978 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Painless injection during dental procedures |
|
Scientific Title of Study
|
A comparative evaluation to check the efficacy of 5% Eutectic mixture of
local anesthetic cream with customized oral mucosal vibrator (Oravibe)
during administration of greater palatine nerve block in patients
undergoing therapeutic extractions. A Split Mouth Randomized
Controlled Trial. |
| Trial Acronym |
ORAVIBE Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pracheta Watane |
| Designation |
Postgraduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongri Hingna Nagpur
Room no 101, 1st floor, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongri Hingna Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8308951519 |
| Fax |
|
| Email |
drprachetawatane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Mishra |
| Designation |
Professor and Head of the department |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Room no 101 1st floor, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongri Hingna Nagpur
Room no 101 1st floor, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongri Hingna Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9860665430 |
| Fax |
|
| Email |
drakshay.mishra@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pracheta Watane |
| Designation |
Postgraduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongri Hingna Nagpur
Room no 101, 1st floor Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongri Hingna Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8308951519 |
| Fax |
|
| Email |
drprachetawatane@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pracheta Watane |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna Nagpur Maharashtra |
| 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 Pracheta Watane |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Room no. 101, 1st floor Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongri Hingna Nagpur
Nagpur
MAHARASHTRA |
8308951519
drprachetawatane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swargiya Dadasaheb Kalmegh smruti Dental College and Hospita; |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Undergoing Therapeutic extractions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5% EMLA (Eutectic mixture of Local Anesthesia) |
EMLA is a local anesthetic cream use to num the area before injection |
| Comparator Agent |
customized oral mucosal vibrator (Oravibe) |
Oravibe is a device used to reduce the pain perception while administrating a palatal nerve block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients advised Bilateral maxillary ortho extraction
Requiring palatal injection
Patient having healthy palatal mucosa
Healthy patients without any allergy or systemic disease
Patient who will give consent for study |
|
| ExclusionCriteria |
| Details |
Patient with a history of allergic reactions to local anaesthetics
Patients with any bleeding disorder
Patient giving history of taking any medications that interacts
with local anesthetics
Patient who does not give consent for study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Injection pain intensity during the greater palatine nerve block, measured on a 0–10 VAS (NRS) (0=worst imaginable pain, 10=no) immediately after injection on each side in the split-mouth design. The score recorded is the highest pain felt during needle penetration and anesthetic deposition. |
Injection pain intensity during the greater palatine nerve block, measured on a 0–10 VAS (NRS) (0=worst imaginable pain, 10=no) immediately after injection on each side in the split-mouth design. The score recorded is the highest pain felt during needle penetration and anesthetic deposition. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain of topical application
Latency to adequate anesthesia
Mucosal vibration tolerance
Soft tissue changes at injection site
Wound healing at extraction site
Patient anxiety level
Duration of vibration-induced desensitization
Functional recovery
Anesthetic success rate
Need for rescue/supplemental anesthesia
Intraoperative procedural pain (extraction)
Patient satisfaction/comfort
Operator ease/satisfaction
Physiological response (heart rate, BP changes)
Adverse events/complications
Analgesic consumption post-op |
Topical pain / vibration tolerance: immediate, 1–2 min
Latency to anesthesia: 1, 4, 8 min
Soft tissue changes: 0 min, 2 hr, 48 hr
Wound healing: Day 1, Day 7, Day 14
Patient anxiety: baseline, 30 min post-procedure
Vibration desensitization: every 15 s up to 3 min
Functional recovery: 48 hr, Day 7
Anesthetic success: 10 min post-injection
Rescue anesthesia need: intraoperative (anytime)
Intraoperative pain: peak during extraction, immediate after
Patient satisfaction: immediate post-procedure, 24 hr
Operator ease: immediate post-procedure
Physiological response: baseline, peak during injection, 5 min
Adverse events: immediate, 24 hr, Day 7
Analgesic consumption: cumulative over 24 hr |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/12/2025 |
| 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="1"
Months="6"
Days="10" |
|
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
|
Primary outcome
Injection pain intensity on NRS 0 to 10 measured at peak during injection immediately after 5 minutes and 10 minutes Secondary outcomes
Pain of topical application and vibration tolerance
Latency and success of anesthesia
Soft tissue changes and wound healing
Patient anxiety satisfaction and functional recovery
Intraoperative pain and need for rescue anesthesia
Operator ease of procedure
Physiological responses heart rate and blood pressure
Adverse events and analgesic consumption Secondary outcome time points concise
Immediate 0 to 2 minutes 5 to 10 minutes intraoperative 30 minutes 2 hours 24 hours Day 1 Day 7 Day 14 as relevant to each outcome |