- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675180
Self Reported Oral Health, Awareness and Attitude Towards Dental Care Among Pregnant Women
March 11, 2026 updated by: University of Tromso
Self Reported Oral Health, Awareness and Attitude Towards Dental Care and Risk of Dental Caries Among Pregnant Women in Norway
Purpose/Objective of the study:
The main objective of the study is to investigate oral health awareness and attitudes towards oral health among Norwegian pregnant women and assess the impact of information about oral hygiene on the risk of dental caries during pregnancy.
The hypothesis of the study are:
- The state of oral health during pregnancy depends on pregnant woman's preventive oral hygiene behaviour and practice.
- Pregnant women with high level of oral health awareness and positive attitude towards oral health are more likely to visit their dentists regularly and have better oral hygiene compared to those with less awareness.
- Proper information and guidance on oral hygiene care provided during pregnancy can help to improve oral bacteriological milieu and reduce the dental caries risk among pregnant women.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Troms
-
Tromsø, Troms, Norway, 9037
- Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Women with viable pregnancy ≥ 17 weeks gestation
Exclusion Criteria:
- Those not willing to participate in the study.
- Women who are unable to communicate well in Norwegian.
- Women who have been diagnosed to have a fetus with a chromosomal or structural fetal anomaly and do not plan to continue their pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Information
Women randomized to the intervention will receive information and counseling on oral health care during pregnancy
|
No intervention
Women in the intervention group will receive information and counseling on oral health care during pregnancy
|
|
No Intervention: Control
Women in non-intervention arm receive usual routine ante-natal care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral health
Time Frame: In 4 weeks interval after recrutiatment of study participants
|
Streptococcus Mutans, lactobacilli
|
In 4 weeks interval after recrutiatment of study participants
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitude
Time Frame: After approximately 6 months
|
Attitude towards oral health care
|
After approximately 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ganesh Acharya, Professor, University of Tromsø and University Hospital of North Norway
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
October 1, 2022
Study Registration Dates
First Submitted
August 27, 2012
First Submitted That Met QC Criteria
August 27, 2012
First Posted (Estimated)
August 29, 2012
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 11, 2026
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19353(2012/633/REK nord)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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