Self Reported Oral Health, Awareness and Attitude Towards Dental Care Among Pregnant Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by University of Tromso
University Hospital of North Norway
Information provided by (Responsible Party):
University of Tromso Identifier:
First received: August 27, 2012
Last updated: October 29, 2015
Last verified: October 2015

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:

  1. The state of oral health during pregnancy depends on pregnant woman's preventive oral hygiene behaviour and practice.
  2. 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.
  3. 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.

Condition Intervention
Oral Health
Other: Information
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Self Reported Oral Health, Awareness and Attitude Towards Dental Care and Risk of Dental Caries Among Pregnant Women in Norway

Resource links provided by NLM:

Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • Oral health [ Time Frame: In 4 weeks interval after recrutiatment of study participants ] [ Designated as safety issue: No ]
    Streptococcus Mutans, lactobacilli

Secondary Outcome Measures:
  • Attitude [ Time Frame: After approximately 6 months ] [ Designated as safety issue: No ]
    Attitude towards oral health care

Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Women randomized to the intervention will recieve information and counseling on oral health care during pregnancy
Other: Information
Women in the intervention group will recieve information and counseling on oral health care during pregnancy
Other: Control
No intervention
No Intervention: Control


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01675180

Contact: Ganesh Acharya, Professor 77626432

Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN) Recruiting
Tromsø, Troms, Norway, 9037
Contact: Ganesh Acharya, Professor    +47 77 62 6432   
Sponsors and Collaborators
University of Tromso
University Hospital of North Norway
Principal Investigator: Ganesh Acharya, Professor University of Tromsø and University Hospital of North Norway
  More Information

No publications provided

Responsible Party: University of Tromso Identifier: NCT01675180     History of Changes
Other Study ID Numbers: 2012/633/REK nord
Study First Received: August 27, 2012
Last Updated: October 29, 2015
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by University of Tromso:
pregnancy, oral health, attitude, awareness, streptococcus mutans, lactobacilli processed this record on November 30, 2015