| CTRI Number |
CTRI/2024/03/063733 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparision of two different sound green noise and white noise on releiving anxiety level in paitent who will be treated by root canal treatment |
|
Scientific Title of Study
|
Comparative evaluation of the Efficacy of Green noise and white noise in Alleviating Anxiety Levels among Patients Undergoing Root Canal Treatment: A Randomized Clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetanjali Jain |
| Designation |
Student |
| Affiliation |
KM DENTAL COLLEGE and HOSPITAL |
| Address |
ROOM NO. 8 DEPARTMENT OF CONSERVATIVE DENTISTRY and ENDODONTICS
KM Shah DentalCcollege and Hospital Piparia road Waghodia 391760
Vadodara
GUJARAT
India
Vadodara
GUJARAT
391760
India |
| Phone |
7415293089 |
| Fax |
|
| Email |
tarangeetanjali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
Professor |
| Affiliation |
KM Shah Dental college and hospital |
| Address |
ROOM NO. 8 DEPARTMENT OF CONSERVATIVE DENTISTRY and ENDODONTICS KM Shah Dental College and Hospital Piparia road Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
0 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
Professor |
| Affiliation |
KM Shah Dental college and hospital |
| Address |
ROOM NO. 8 DEPARTMENT OF CONSERVATIVE DENTISTRY and ENDODONTICS KM Shah dental college and hospital piparia road waghodia gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
0 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM shah dental college and hospital piparia wagodiya vadodara gujrat 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Geetanjali Jain |
| Address |
ROOM NO. 8 DEPARTMENT OF CONSERVATIVE DENTISTRY and ENDODONTICS KM Shah Dental College and Hospital Piparia Road Waghodia Gujarat 391760
Vadodara
GUJARAT
India |
| 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 Geetanjali Jain |
km shah dental college and hospital piparia road waghodiya |
ROOM NO. 8 DEPARTMENT OF CONSERVATIVE DENTISTRY and ENDODONTICS,Piparia road Waghodia Gujarat 391760
Vadodara
Vadodara
GUJARAT |
7415293089
tarangeetanjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Green noise |
To evaluate the efficacy of green noise in alleviating anxiety levels among patients undergoing root canal treatment |
| Comparator Agent |
WHITE NOISE |
To evaluate the efficacy of WHITE noise in alleviating anxiety levels among patients undergoing root canal treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between age group of 18-60 years (ASA classification 1&2) with maxillary or mandibular single canal, single Rooted teeth diagnosed with Symptomatic Irreversible Pulpitis with normal periapical tissues will be included in the study.
2.Teeth with radiographic findings revealing radiolucency in enamel, dentin involving pulp with no periapical changes will be included.
3.A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
4. Ability to hear radio or TV easily without the use of a hearing aid will be included in the study
5.Proficient in speaking and understanding language for effective communication will be included in the study
6.Patients recommended or indicated for primary endodontic treatment will be included in the study
|
|
| ExclusionCriteria |
| Details |
1.Patients with severe or chronic apical periodontitis will be excluded.
2.Teeth with periapical abscess, granuloma, cyst will be excluded.
3.Medically compromised patients will be excluded.
4.Teeth with open apex & root resorption will be excluded.
5.Teeth with complex Root canal anatomy will be excluded.
6.Pregnant and lactating women will be excluded.
7.Patients with significant hearing impairment or those using hearing aids will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the study will help us to know if green noise or white noise will help in releiving anxiety in patients undergoing root canal treatment |
2 hours |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/03/2024 |
| 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
|
A lot of patients feel anxious when coming to a dental clinic because of the fear of injections and drills and eventually lead to increase in their blood pressure which can complicate dental procedures mostly root canal treatment . so in this study we are incorporating white and green noise which helps in calming the autonomic nervous system and puts a hush to the adrenaline jitters . since white noise have already been studied in alot of studies but green noise is emerging as a newer concept and hence is the need for this study |