| CTRI Number |
CTRI/2022/10/046135 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Use of Brainwave Entrainment for pain control in Dentistry |
|
Scientific Title of Study
|
Application of Brainwave Entrainment for Pain Control in Dentistry. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha Mani |
| Designation |
Assistant Professor |
| Affiliation |
SRM Kattankulathur Dental College and Hospital |
| Address |
flat no.B3, Oak block, padikuppam road, annanagar,
chennai.
Department of Conservative Dentistry, room no.105, SRM Kattankulathur dental college and Hospital, Potheri, 603203.
Kancheepuram
TAMIL NADU
600040
India |
| Phone |
9444810543 |
| Fax |
|
| Email |
rekham@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Vivek |
| Designation |
Dean, Professor |
| Affiliation |
SRM Kattankulathur Dental College and Hospital |
| Address |
SRM Kattankulathur dental college and Hospital, Potheri, Chengalpattu district.
Dean, SRM Kattankulathur dental college and Hospital, Potheri, Chengalpattu district.603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444360303 |
| Fax |
|
| Email |
dean.dental.ktr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rekha Mani |
| Designation |
Assistant Professor |
| Affiliation |
SRM Kattankulathur Dental College and Hospital |
| Address |
Department of Conservative Dentistry, room no.105, SRM Kattankulathur dental college and Hospital, Potheri, Chengalpattu district.
Department of Conservative Dentistry, room no.105, SRM Kattankulathur dental college and Hospital, Potheri, Chengalpattu district.603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444810543 |
| Fax |
|
| Email |
rekham@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Kattankulathur Dental College and Hospital, SRM University, Kattankulathur. |
|
|
Primary Sponsor
|
| Name |
Rekha Mani |
| Address |
Department of Conservative Dentistry, room no.105, SRM Kattankulathur dental college and Hospital, Potheri, Chengalpattu district. 603203 |
| 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 Rekha |
SRM Kattankulathur Dental College and Hospital |
Department of Conservative Dentistry, room no.105, SRM Kattankulathur dental college and Hospital, Potheri, Chengalpattu district.603203
Kancheepuram
TAMIL NADU |
9444810543
rekham@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients reporting with dental pain |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brainwave Entrainment |
10 minute session of audio visual brain wave entrainment in alpha, beta, theta or delta frequencies, based on the group) using David delight plus audio visual device for entrainment, manufactured by Mind Alive Inc. Edmonton, Alberta, Canada. |
| Comparator Agent |
conventional technique of local anesthesia and instrumentation |
administration of infiltration anesthesia and pulp extirpation following conventional anesthesia serve as comparator agent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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.
• American society of Anesthesiologists (ASA)-I, II
|
|
| ExclusionCriteria |
| Details |
Patients with allergies and hypersensitivity to medications, anesthetic solution or its components used in the study,
Epilepsy, Head injury,
Psychiatric illness,
Substance abusers.
• Pregnant or nursing women
• ASA III and above. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
assessment of pain following entrainment session during dental procedures.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| addresses the 4 types of brain waves employed for entrainment and assesses which wave provides for improved pain control. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 hundred patients 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. |