Painless injection during dental procedures

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. - ORAVIBE Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097978

Enrollment

Registered

2025-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 5% EMLA (Eutectic mixture of Local Anesthesia): EMLA is a local anesthetic cream use to num the area before injection Control Intervention1: customized oral mucosal vibrator (Oravibe):

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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

Measure	Time frame
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-opTimepoint: 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	—

Measure

Time frame

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-opTimepoint: 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

—

Countries

India

Contacts

Public ContactDr Pracheta Watane

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital

drakshay.mishra@sdk-dentalcollege.edu.in9860665430

Outcome results