We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01675180
Recruitment Status : Unknown
Verified October 2015 by University of Tromso.
Recruitment status was:  Recruiting
First Posted : August 29, 2012
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Pregnancy Oral Health Attitude Other: Information Other: Control

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Official Title: Self Reported Oral Health, Awareness and Attitude Towards Dental Care and Risk of Dental Caries Among Pregnant Women in Norway
Study Start Date : February 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Oral health [ Time Frame: In 4 weeks interval after recrutiatment of study participants ]
    Streptococcus Mutans, lactobacilli

Secondary Outcome Measures :
  1. Attitude [ Time Frame: After approximately 6 months ]
    Attitude towards oral health care

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675180

Contact: Ganesh Acharya, Professor 77626432 ganesh.acharya@uit.no

Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN) Recruiting
Tromsø, Troms, Norway, 9037
Contact: Ganesh Acharya, Professor    +47 77 62 6432    ganesh.acharya@uit.no   
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

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01675180     History of Changes
Other Study ID Numbers: 2012/633/REK nord
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

Keywords provided by University of Tromso:
pregnancy, oral health, attitude, awareness, streptococcus mutans, lactobacilli