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CTRI Number  CTRI/2025/07/090714 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of the oral health condition(teeth, gum health) and oral health related quality of life in women with polycystic ovarian syndrome (PCOS) and women without the condition. 
Scientific Title of Study   Oral health status and Oral health related quality of life in females with polycystic ovarian syndrome: A comparative 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 JEEVAN V SAMBASIVAN 
Designation  Post Graduate Student  
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No:8, Department of Public Health Dentistry, 2nd floor, Manipal College of Dental Sciences, Manipal Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India.

Udupi
KARNATAKA
576104
India 
Phone  6361892783  
Fax    
Email  thesisjvn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr DEEPAK KUMAR SINGHAL 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No:8, Department of Public Health Dentistry, 2nd floor, Manipal College of Dental Sciences, Manipal Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India.

Udupi
KARNATAKA
576104
India 
Phone  9379060983  
Fax    
Email  dk.singhal@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr JEEVAN V SAMBASIVAN 
Designation  Post Graduate Student  
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No:8, Department of Public Health Dentistry, 2nd floor, Manipal College of Dental Sciences, Manipal Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India.

Udupi
KARNATAKA
576104
India 
Phone  6361892783  
Fax    
Email  thesisjvn@gmail.com  
 
Source of Monetary or Material Support  
MCODS, Room No:8, Department of Public Health Dentistry, 2nd floor, Manipal College of Dental Sciences, Manipal Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India. 
 
Primary Sponsor  
Name  Dr JEEVAN V SAMBASIVAN 
Address  Room No:8, Department of Public Health Dentistry, 2nd floor, Manipal College of Dental Sciences, Manipal Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India. 
Type of Sponsor  Other [Self Funded] 
 
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 
Dr JEEVAN V SAMBASIVAN  Dr. T.M.A Pai Hospital, Udupi  Department of Obstetrics and Gynecology O.P.D, 1st Floor, Dr. T.M.A Pai Hospital, court road, opp. Old Taluk Office, Brahmagiri, Udupi, Karnataka - 576101
Udupi
KARNATAKA 		 6361892783

thesisjvn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy females without the condition of polycystic ovarian syndrome  
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  a)Healthy females aged 18-45 years with PCOS,
b)Confirmed diagnosis of PCOS based on the Rotterdam criteria
c)Participants who are ready to participate and give informed consent for the study.
 
 
ExclusionCriteria 
Details  a)Pregnant females or breastfeeding mothers.
b)Participants with a history of conditions similar to PCOS like congenital adrenal hyperplasia, Cushing’s syndrome, etc.
c)History of ovarian cancer or surgery or other gynecological conditions affecting ovarian function
d)History of osteoporosis.
e)Participants with BMI more than 25
f)Differentially abled and those under psychotic medication.
g)Participants who are not willing to give informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of the oral health status and oral health-related quality of life (OHRQoL) in females with PCOS and healthy females.
 		 baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of the role of lifestyle & psychosocial factors associated with PCOS & oral health.   baseline 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/07/2025 
Date of Study Completion (India) 30/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
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 study is a comparative, cross-sectional study designed to assess and compare the oral health status and oral health-related quality of life among females with polycystic ovary syndrome and healthy females. It also aims to evaluate the lifestyle and psychosocial factors associated with PCOS and oral health. Females aged 18 to 45 years will be included in the study. Group one will consist of females with PCOS diagnosed using the Rotterdam criteria, and group two will include healthy females without PCOS. Clinical oral examinations will be performed, and validated questionnaires such as OHIP 14, PSS 4, and the Health Practices Index will be used to collect data. The data will be analyzed using appropriate statistical methods. This study will provide insights into the oral health impact of PCOS and highlight the need for integrated care for affected individuals. 
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