Use of Brainwave Entrainment for pain control in Dentistry

Not yet recruiting

Conditions: patients reporting with dental pain
Pulpitis,

Registration Number: CTRI/2022/10/046135

Lead Sponsor: Rekha Mani

Brief Summary: **Background -**

Dental pain management mainly depends on successful local anesthesia, the efficacy of which exorbitantly decreases in the presence of inflammation and sensitized TTX-R channels. Recent studies have demonstrated the key role brainwaves in pain processing*,* depicting an increase in gamma oscillations during pain and reversal of pain by application of alpha oscillations, via external stimulus.

**Objectives-** to assess

**1.**Effectiveness of BWE for pain control during Infiltration anesthesia (non-inflammatory group) and Endodontic therapy ( inflammatory group)

**Methodology**

For inflammatory group,Three hundredpatients actively experiencing pain (recorded using Heft-Parker VAS), diagnosed with symptomatic irreversible pulpitis in mandibular molars will be included. After cold test, all patients will receive standard inferior alveolar nerve block with 2% lignocaine. Post-anesthetic pain scores and cold test will be assessed followed by endodontic access. Patients experiencing pain (VAS 55-170 mm) during treatment, will be allocated to one of the four entrainment groups (alpha, beta, theta and delta). A 10-minute audiovisual entrainment (David-delight-plus-entrainment-device) will be applied and treatment will be continued under entrainment. Success is defined as ability to access and instrument the tooth without pain (VAS 0-54 mm).

For the non-inflammatory group, participants willing to volunteer for infiltration anesthesia in maxillary anterior region without evidence of periapical pathosis will be included. After 8 minutes, the participants will be instructed to open their mouth by an external audio input, the facility for which is provided in the device. All participants will be given 1.8ml of lignocaine infiltration for 60 seconds. Pain of needle insertion and LA deposition to be assessed using Heft-Parker VAS.

**Expected outcomes**

1. Effectiveness of BWE for pain control during infiltration anesthesia and endodontic therapy will be ascertained.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

Participants willing and fulfilling the study criteria in the age group of 18-50 years, Patients experiencing moderate to severe pain (55-170mm ) readings in Heft-Parker VAS, Patients who had not taken analgesics for atleast 12 hours before enrollment in the study.
â€¢American society of Anesthesiologists (ASA)-I, II.

Exclusion Criteria

Patients with allergies and hypersensitivity to medications, anesthetic solution or its components used in the study, Epilepsy, Head injury, Psychiatric illness, Substance abusers.
â€¢Pregnant or nursing women â€¢ASA III and above.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assessment of pain following entrainment session during dental procedures.	1 year

Secondary Outcome Measures

Name	Time	Method
addresses the 4 types of brain waves employed for entrainment and assesses which wave provides for improved pain control.	1 year

Trial Locations

Locations (1): SRM Kattankulathur Dental College and Hospital
🇮🇳
Kancheepuram, TAMIL NADU, India
SRM Kattankulathur Dental College and Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Dr Rekha
Principal investigator
9444810543
rekham@srmist.edu.in