| CTRI Number |
CTRI/2024/06/068365 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of skin conductance responses in Endodontic Diagnosis of Patients with Limited Communication: A Clinical Study" |
|
Scientific Title of Study
|
Evaluation of electrodermal activity during endodontic diagnostic procedure in patients with limited communication: An in vivo 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. Geddam Pravallika |
| Designation |
Doctor |
| Affiliation |
St Joseph Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College and Hospital, Duggirala, Eluru. 534003 India.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
7893428210 |
| Fax |
|
| Email |
pravallikarao1965@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srihari Devalla |
| Designation |
Professor |
| Affiliation |
St Joseph Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College, Duggirala, Eluru. 534003
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9440134678 |
| Fax |
|
| Email |
drsriharidevalla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srihari Devalla |
| Designation |
Professor |
| Affiliation |
St Joseph Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College, Duggirala, Eluru. 534003
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9440134678 |
| Fax |
|
| Email |
drsriharidevalla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, St. Joseph Dental College, Duggirala, Eluru. 534003 |
|
|
Primary Sponsor
|
| Name |
Geddam Pravallika |
| Address |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College, Duggirala, Eluru. 534003 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 Geddam Pravallika |
St. Joseph Dental College and Hospital, Duggirala, Eluru |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College and Hospital, Duggirala, Eluru 534003 India.
West Godavari
ANDHRA PRADESH |
7893428210
pravallikarao1965@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ASRAMS BHR Ethics Committee |
Approved |
| ST JOSEPH DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with limited communication ability are included.
Patients with dental caries.
Teeth without sinuses, swelling or looseness.
Periapical radiographs indicating that the root apices of all teeth had completely developed.
Affected teeth are endodontically involved.
|
|
| ExclusionCriteria |
| Details |
Patients with cardiac pacemakers.
Pregnant patients.
Patients undergoing orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Objective measurement of pain |
One Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/06/2024 |
| 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 Yet Recruiting |
| 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
Modification(s)
|
The aim of the study is to explore whether electrodermal activity (EDA) can serve as a complementary tool for pulpal diagnosis. The main objective of the study is to evaluate electrodermal activity (EDA) activity during endodontic diagnostic procedure in patients with good communication and patients with limited communication. Patients coming to the out-patient department of Conservative Dentistry and Endodontics, St. Joseph Dental College and Hospital, Duggirala, Eluru and patients coming to the out-patient department of dental wing, Asram Medical College, Eluru are taken into consideration. Informed consent will be taken from patients who can communicate effectively on their own and those who are unable to do so will be taken from their parents/ guardians. Patients will be categorized based on Corah’s dental anxiety scale. Electrodermal activity during endodontic diagnostic procedures will be evaluated in both the groups and the results will be statistically analyzed. |