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CTRI Number  CTRI/2022/09/045857 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 27/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Adverse pregnancy outcomes in females with periodontitis  
Scientific Title of Study   Assessment OF The Relationship Between Maternal Periodontal Disease Status And Their Pregnancy Outcomes In A Cohort From Yamunanagar - A Prospective Study 
Trial Acronym  APO-FP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohan Khare 
Designation  PG student 
Affiliation  J.N. Kapoor DAV (c) Dental College, Yamuna Nagar 
Address  Department of Periodontology and Oral Implantology, J.N. Kapoor DAV (c) Dental College, Yamuna Nagar

Yamunanagar
HARYANA
135001
India 
Phone  8708884640  
Fax    
Email  rohankhare2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Gugnani 
Designation  Professor 
Affiliation  J.N. Kapoor DAV (c) Dental College, Yamuna Nagar 
Address  Department of Periodontology and Oral Implantology, J.N. Kapoor DAV (c) Dental College, Yamuna Nagar

Yamunanagar
HARYANA
135001
India 
Phone  9466949150  
Fax    
Email  drshalinigugnani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rohan Khare 
Designation  PG student 
Affiliation  J.N. Kapoor DAV (c) Dental College, Yamuna Nagar 
Address  Department of Periodontology and Oral Implantology, J.N. Kapoor DAV (c) Dental College, Yamuna Nagar

Yamunanagar
HARYANA
135001
India 
Phone  8708884640  
Fax    
Email  rohankhare2@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology and Oral Implantology, J.N. Kapoor DAV (c) Dental College, Yamuna Nagar 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rohan Khare  J.N. Kapoor DAV (c) Dental College, Yamuna Nagar  Room No. 8, Department of Periodontology and Oral Implantology
Yamunanagar
HARYANA 		 8708884640

rohankhare2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE J.N. KAPOOR DAV centenary DENTAL COLLEGE, YAMUNANAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Healthy pregnant females in 14-26 weeks of gestation.
2. Females with singleton pregnancy.
3. Participants from 20-40 years of age.
4. Pregnant women willing to participate in the study.
5. Females with at least 20 teeth.
6. Pregnant females willing to give consent for the clinical periodontal examination and share their medical records with the Periodontist.  
 
ExclusionCriteria 
Details  1. Pregnant females less than 20 years of age and less than 20 teeth.
2. Alcohol or drug abuse.
3. Multifetal gestation.
4. Known systemic conditions such as pre-pregnancy hypertension, diabetes mellitus, active hepatic disease, infectious condition requiring antibiotic
treatment.
5. Females with positive history of AIDS. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Preterm birth (PB).
2) Low birth weight (LBW).
3) Preterm low birth weight (PLBW).
4) Preeclampsia (PE).
5) Normal delivery (ND). 		 At the time of delivery of the infant 
 
Secondary Outcome  
Outcome  TimePoints 
1) Plaque index (PI).
2) Probing depth (PD).
3) Clinical attachment loss (CAL). 		 From 14-26 weeks of gestation (Second Trimester) 
 
Target Sample Size   Total Sample Size="217"
Sample Size from India="217" 
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)   27/09/2022 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  In the form of excel sheet of the participants in the study

  6. For how long will this data be available start date provided 27-04-2023 and end date provided 27-06-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Healthy pregnant females of age group 20-40 years, with singleton pregnancy will be recruited from 14-26 weeks of gestation (Second trimester). Complete clinical periodontal examination will be performed, recording the Plaque Index, Probing depth and Clinical attachment loss. Then the patient’s will be followed till delivery of their infant and at the time of delivery, primary outcomes variables such as gestational age at the time of delivery, birth weight of the infant, any history of APO and the type of delivery will be recorded.  
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