| CTRI Number |
CTRI/2026/03/106290 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of music with giving anesthesia in patient with Severe Toothache (Pulpitis) |
|
Scientific Title of Study
|
Effect of Audio analgesics on Local Anaesthesia in Patient with Symptomatic Irreversible Pulpitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Hasna Bukhari |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Sector 43, surajkund Road,manav rachna dental college
Department of Conservative dentistry and Endodontics, room no-7, 2nd floor
Faridabad
HARYANA
121004
India |
| Phone |
01294268800 |
| Fax |
|
| Email |
Seema.sds@mrei.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Hasna Bukhari |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Sector 43, surajkund Road,manav rachna dental college
Department of Conservative dentistry and Endodontics
Faridabad
HARYANA
121004
India |
| Phone |
01294268800 |
| Fax |
|
| Email |
Seema.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Seema Hasna Bukhari |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Sector 43, surajkund Road,manav rachna dental college
Department of conservative dentistry and endodontics, 2nd floor, room no-7
Faridabad
HARYANA
121004
India |
| Phone |
01294268800 |
| Fax |
|
| Email |
Seema.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College |
|
|
Primary Sponsor
|
| Name |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College |
| 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 Seema Hasna Bukhari |
Manav Rachna Dental College |
Department of Conservative dentistry and Endodontics, 2nd floor, room no. 7
Faridabad
HARYANA |
8800877109
seema.sds@mrei.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptomatic irreversible pulpitis |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 percent lidocaine |
Anesthesia without music |
| Intervention |
Local Anesthesia |
2 percent lidocaine with music |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
55.00 Day(s) |
| Gender |
Both |
| Details |
Permanent mandibular molar, Patient not having any medical condition, Absence of internal and external pus and swelling. |
|
| ExclusionCriteria |
| Details |
Teeth other than permanent mandibular molar, patient having any medical condition, presence of internal and external pus and swelling. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| according to literature audio Analgesic have positive effect of efficacy of local anesthesia |
according to literature audio Analgesic have positive effect of efficacy of local anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety |
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
27/06/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with symptomatic irreversible pulpitis in permanent mandibular molars, without systemic disease, swelling, or sinus tract, were included, while reversible pulpitis, other teeth, medically compromised patients, and those with swelling were excluded. Following history taking and clinical examination, preoperative pain and anxiety were assessed using standardized scales. All patients received 2 ml lignocaine with adrenaline via inferior alveolar nerve block. Seventy patients were randomly divided into two groups (n = 35 each): Group A received local anesthesia with audio analgesia, and Group B received local anesthesia alone. Postoperative pain and anxiety were evaluated using the Visual Analogue Scale (VAS) and Corah’s Dental Anxiety Scale. |