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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  
Status 
Not Applicable 
 
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.

 
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