| CTRI Number |
CTRI/2024/08/072764 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Dental Treatment among Pregnant women |
|
Scientific Title of Study
|
EFFECTIVENESS OF ORAL HEALTH PROMOTION PROGRAM AMONG PREGNANT WOMEN ATTENDING TERTIARTY CARE HOSPITAL IN MANGALORE CITY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shreshtha shetty |
| Designation |
assistant professor |
| Affiliation |
A.J.Institute of Dental sciences |
| Address |
A.J Institute of Dental Sciences,Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9916816743 |
| Fax |
|
| Email |
shreshthashetty8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
shreshtha shetty |
| Designation |
assistant professor |
| Affiliation |
A.J.Institute of Dental sciences |
| Address |
A.J Institute of Dental Sciences,Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9916816743 |
| Fax |
|
| Email |
shreshthashetty8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shreshtha shetty |
| Designation |
assistant professor |
| Affiliation |
A.J.Institute of Dental sciences |
| Address |
A.J Institute of Dental Sciences,Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9916816743 |
| Fax |
|
| Email |
shreshthashetty8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Laxmi memorial education trust
AJ Towers, Upper Bendoor 2nd Cross Rd, near Post Office, Balmatta, Mangaluru, Karnataka 575002 |
|
|
Primary Sponsor
|
| Name |
shreshtha shetty |
| Address |
A.J Institute of Dental Sciences,Mangalore |
| Type of Sponsor |
Other [] |
|
|
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 |
| shreshtha shetty |
A.J Institute of dental Sciences,Mangalore |
dept of public health dentistry, room number 9, 3rd floor
Dakshina Kannada
KARNATAKA |
9916816743
shreshthashetty8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AJIDS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dental treatment |
Dental Treatments such as Oral Prophylaxis, Restorations, Preventive treatment, Oral Urgent Treatment and Tobacco cessation counselling will be provided |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women aged 20 to 35 years and is in their second trimester of pregnancy
2.Received no periodontal treatments
3.No history of antibiotics in the previous 3 months.
|
|
| ExclusionCriteria |
| Details |
1.Individuals not fulfilling the inclusion criteria or declining blood or saliva collection.
2.Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oral health status |
baseline and after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pregnancy outcome |
after delivery |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
25/08/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Effectiveness
of comprehensive Oral health promotional intervention among pregnant
women will be evaluated. |