| CTRI Number |
CTRI/2025/02/079866 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of pregnant women oral health status and pre term low birth weight infants |
|
Scientific Title of Study
|
Relationship of serum biomarkers with maternal periodontal health status and pre term low birth weight infants:A Cross Sectional 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 Aditi Dhama |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9068203432 |
| Fax |
|
| Email |
aditi.dhama7911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Bansal |
| Designation |
Professor |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
drmansibansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Khatri |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810720335 |
| Fax |
|
| Email |
drmanishkhatri@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Studies and Technologies,Address:Room no.7,Department of Periodontics,NH-58,Delhi-Meerut Road,Kadrabad,Modinagar,Uttar Pradesh,India-201201 |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies |
| Address |
Institute of Dental Studies and Technologies,Address:Room no.7,Department of Periodontics,NH-58,Delhi-Meerut Road,Kadrabad,Modinagar,Uttar Pradesh,India-201201 |
| 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 Aditi Dhama |
Institute of Dental Studies & Technologies |
Department of Periodontology, Room no 7, Institute of Dental Studies & Technologies, kadrabad, Modinagar
Ghaziabad
UTTAR PRADESH |
9068203432
aditi.dhama7911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, (2) ICD-10 Condition: K054||Periodontosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Post-partum females with normal term and normal birth weight infants,normal term and low birth weight infants,pre term and normal birth weight infants,pre term low birth weight infants. |
|
| ExclusionCriteria |
| Details |
Artificial Reproductive Technology and multiple Gestations
Known history of hypertension/Diabetes/ any systemic illness
History of smoking,alcohol and drug abuse |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque index
Gingival index
Community Periodontal index
Ballard gestational age assessment chart
MMP8 Serum level |
Single visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This cross- sectional study will include postpartum females aged 18-40 years without systemic issues before or during pregnancy, from hospitals near Institute of Dental Studies & Technologies, Modinagar. Participants will be categorzied based on infant weight (<2,500 g or > 2,500g) and gestational age (<37 weeks or > 37 weeks) where in infant weight will be obtained within the 1st year of life, and gestational age will be assessed using Ballard’s gestational age assessment chart. Accordingly participants will be classified in either of four groups: Group 1: Postpartum females with normal term and normal birth weight Group 2: Postpartum females with normal term and low birth weight Group 3: Postpartum females with pre term and normal birth weight Group 4: Postpartum females with pre term and low birth weight And MMP8 serum will be assessed using ELISA |