| CTRI Number |
CTRI/2024/02/062600 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence Of Temporo Mandibular Disprders in Married Working Women |
|
Scientific Title of Study
|
Prevalence OF TMDs IN Married Working Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chagalamarri Nanda Kiran |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College And Hospital |
| Address |
Narayana Dental College and Hospital, Department of Oral Medicine and Radiology , Room No.1 , Chinthareddypalem Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
08008232929 |
| Fax |
|
| Email |
nandakiran121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Kumar Manne |
| Designation |
Proffesor |
| Affiliation |
Narayana Dental College And Hospital |
| Address |
Narayana Dental College and Hospital, Department of Oral Medicine And Radiology, Room No.1 , Chinthareddypalem Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9704014747 |
| Fax |
|
| Email |
rmannae@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chagalamarri Nanda Kiran |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College And Hospital |
| Address |
Narayana Dental College and Hospital, Department of Oral Medicine And Radiology, Room No.1 , Chinthareddypalem, Nellore.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
08008232929 |
| Fax |
|
| Email |
nandakiran121@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College And Hospital |
|
|
Primary Sponsor
|
| Name |
Chagalamarri Nanda Kiran |
| Address |
Narayana dental college and hospital chinthareddypalem Nellore |
| 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 Chagalamarri Nanda Kiran |
Narayana Dental College and Hospital |
Department of Oral Medicine And Radiology, Room No.1, Chinthareddypalem, Nellore.
Nellore
ANDHRA PRADESH |
8008232929
nandakiran121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NARAYANA DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Married Working Women willing to participate
in the study and visits to the Deptment of Oral Medicine and Radiology, Narayana Dental
College and Hospital, will be included.
2.The Married Working Women Who completed
their graduation. |
|
| ExclusionCriteria |
| Details |
1) Patients not willing to participate in study.
2) Patients undergoing treatment for
psychological stress.
3) Patients with TMD’s and under medication for
the same.
4) Patients with traumatic injuries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analysis of Prevalence of TMDs in patients visiting to the hospital |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Precautionary measures will be given to the patients diagnosed with TMDs |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
13/02/2024 |
| 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="0"
Months="6"
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
|
Patients will be clinically evaluated for TMJ disorders using diagnostic criteria for most common intra articular disorders according to Axis 1, History will be taken for pain in face ,and on clinical examination, conformation for grating , grinding and clicking sounds , evaluated. Prepared a questionnaire of regarding TMDs in working married women will be conducted on the patients who visits to the hospital for a period of about 6 months, Based on this questionnaire report will analyse the prevalence of TMDs in working married women. |