| CTRI Number |
CTRI/2024/02/062581 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A follow up study to see association of Periodontitis, Diabetes in Pregnant Females and Adverse Pregnancy Outcomes. |
|
Scientific Title of Study
|
Association of Periodontitis, Gestational Diabetes Mellitus and Adverse Pregnancy Outcomes: A Prospective 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 |
Nancy Budakoti |
| Designation |
Junior Resident, MDS Periodontia |
| Affiliation |
Dr Ziauddin Ahmed Dental College and Hospital, Aligarh Muslim University |
| Address |
Department of Periodontia and Community Dentistry, Dr. Ziauddin Ahmed Dental College and Hospital, Aligarh Muslim University Campus, Medical Road, Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
8178210856 |
| Fax |
|
| Email |
nancybudakoti98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
N.D GUPTA |
| Designation |
Professor |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Periodontia and Community Dentistry, Dr. Ziauddin Ahmed Dental College and Hospital, Aligarh Muslim University Campus, Medical Road, Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
9412817009 |
| Fax |
|
| Email |
ndguptaligarh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nancy Budakoti |
| Designation |
Junior Resident, MDS Periodontia |
| Affiliation |
Dr Ziauddin Ahmed Dental College and Hospital, Aligarh Muslim University |
| Address |
Department of Periodontia and Community Dentistry, Dr. Ziauddin Ahmed Dental College and Hospital, Aligarh Muslim University Campus, Medical Road, Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
8178210856 |
| Fax |
|
| Email |
nancybudakoti98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontia and Community Dentistry, ZADC, Department of Obstetrics and Gynaecology,
Interdisciplinary Biotechnology Unit, Rajiv Gandhi centre for Diabetes, JNMCH, Aligarh Muslim University Campus, Medical Road, Aligarh Uttar Pradesh, 202002 |
|
|
Primary Sponsor
|
| Name |
Department of Periodontia and Community Dentistry ZADC |
| Address |
Department of Periodontia and Community Dentistry, Ziauddin Ahmed Dental College and Hospital, AMU Campus, Medical Road, Aligarh 202002 |
| Type of Sponsor |
Other [Government Dental College ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Obstetrics and Gynaecology |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University |
| Interdisciplinary Biotechnology Unit |
Interdisciplinary Biotechnology Unit, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University |
| Rajiv Gandhi centre for Diabetes And Endocrinology |
Rajiv Gandhi centre for Diabetes And Endocrinology, Jawaharlal Nehru Medical College and Hospital,Aligarh Muslim University |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nancy Budakoti |
Jawaharlal Nehru Medical College and Hospital |
Department of Obstetrics and Gynaecology, Aligarh Muslim University Campus, Aligarh, 202002 Aligarh UTTAR PRADESH |
8178210856
nancybudakoti98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, FACULTY OF MEDICINE, JNMC, A.M.U, ALIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Age of 18 years and above.
Gestational age of 10-14 weeks.
Participants who provided written approval |
|
| ExclusionCriteria |
| Details |
1)Age less than 18 years.
2)Participants with pregestational diabetes or family History of Diabetes mellitus.
3)Participants with chronic diseases and alcohol/tobacco abuse.
4) participants underwent periodontal or antibiotic therapy within 3 months of recruitment |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gestational Diabetes Mellitus |
Second visit, during 24th-28th weeks of Gestational age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Pregnancy Outcomes, like preterm & low birth weight |
Third Visit, post delivery |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| 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)
|
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 is a Prospective cohort study with aim of studying association of Periodontal status and Salivary TNF-alpha level with Gestational Diabetes Mellitus and Adverse pregnancy outcomes in pregnant women. Periodontitis is a global health problem and is strongly associated with systemic diseases. Prevalence of Gestational diabetes mellitus is also growing in line with the spread of diabetes mellitus. Chronic inflammation have been implicated in the pathogenesis of GDM. Periodontal Disease is associated with increased level of systemic inflammation mediators and can be a potential risk factor for GDM. Both Periodontal Disease and GDM are associated with increased systemic inflammation, pregnant females suffering from both may have increased risk of developing Adverse Pregnancy Outcomes. Participant recruitment is going to be done in Department of Obstetrics and Gynaecology, JNMCH. 100 number of participants in each exposed (periodontitis) and unexposed group (gingivitis and clinically healthy gingiva). Participants during 10th to 14th weeks of Gestation are screened and grouped based on periodontal condition . Around 24th to 28th weeks of Gestation second visit is planned and primary outcome (Gestational Diabetes mellitus) is evaluated. Adverse Pregnancy Outcomes assessment will be done post delivery. Comprehensive oral hygiene instructions will be given to all and oral prophylaxis is administered if deemed necessary. Salivary Samples collection will be done during first and second visit and stored as per standardization later to be assessed for TNF-alpha level estimation. |