| CTRI Number |
CTRI/2026/01/100899 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Understand How Self-Confidence and Oral Health Affect the Quality of Life of Pregnant Women |
|
Scientific Title of Study
|
Self-esteem and oral health related quality of life among pregnant women: A cross-sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neharika Trehan |
| Designation |
Post Graduate student |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib, Himachal Pradesh. |
| Address |
Department of Periodontics, Room no 4, Himachal Institute of Dental Sciences, Poanta Sahib, Himachal Pradesh.
Sirmaur HIMACHAL PRADESH 173025 India |
| Phone |
07833851030 |
| Fax |
|
| Email |
neharika.trehan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Parveen Dahiya |
| Designation |
Professor |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
| Address |
Department of Periodontics, Room no 4, Himachal Institute of Dental Sciences, Poanta Sahib, Himachal Pradesh.
Sirmaur HIMACHAL PRADESH 173025 India |
| Phone |
9857373300 |
| Fax |
|
| Email |
parveen_132@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Parveen Dahiya |
| Designation |
Professor |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib, Himachal Pradesh. |
| Address |
Department of Periodontics, Room no 4, Himachal Institute of Dental Sciences, Poanta Sahib, Himachal Pradesh. Paonta Sahib Sirmaur HIMACHAL PRADESH 173025 India |
| Phone |
9857373300 |
| Fax |
|
| Email |
parveen_132@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Individual Dr Neharika Trehan |
| Address |
Department of Periodontics, Room no 4, Himachal Institute of Dental Sciences, Poanta Sahib, Himachal Pradesh. |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 NEHARIKA TREHAN |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
ROOM NO 4, DEPARTMENT OF PERIODONTICS,HIMACHAL INSTITUTE OF DENTAL SCIENCES, POANTA SAHIB, HIMACHAL PRADESH. Sirmaur HIMACHAL PRADESH |
07833851030
neharika.trehan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Himachal Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral health–related quality of life and self-esteem in pregnant females
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
pregnant females only |
|
| ExclusionCriteria |
| Details |
medically compromised patients and non pregnant females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oral health–related quality of life score measured using OHIP-14 at the time of survey
|
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| self-esteem using Rosenberg self esteem scale |
BASELINE |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
20/02/2026 |
| 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="2" Months="3" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Periodontitis is a common chronic inflammatory disease affecting the supporting tissues of the teeth and may negatively influence oral health–related quality of life (OHRQOL). Oral health is an essential component of general health and well-being, enabling individuals to eat, speak, and socialize without discomfort or embarrassment. In recent years, the concept of OHRQOL has gained importance as it reflects not only the absence of disease but also the physical, psychological, and social impacts of oral conditions on daily life. OHRQOL is a multidimensional construct influenced by functional limitation, pain and discomfort, psychological well-being, social interaction, and self-esteem. Self-esteem is a vital personal attribute that contributes to overall quality of life and health-related behaviors. Individuals with higher self-esteem tend to report better perceived oral health and are more likely to engage in positive oral hygiene practices. Pregnancy is a unique physiological and emotional period during which oral health problems may have significant effects on physical, mental, and social well-being. Despite increasing awareness of oral health during pregnancy, limited evidence exists on the relationship between periodontal disease, self-esteem, and OHRQOL in pregnant women. Therefore, this study aims to assess the association between periodontal status, self-esteem, and oral health–related quality of life among pregnant women. |