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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by University of Tromso
Sponsor:
Collaborator:
University Hospital of North Norway
Information provided by (Responsible Party):
University of Tromso
ClinicalTrials.gov Identifier:
NCT01675180
First received: August 27, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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
Pregnancy
Oral Health
Attitude
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: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Information
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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01675180

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

Locations
Norway
Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN) Not yet 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
Investigators
Principal Investigator: Ganesh Acharya, Professor University of Tromsø and University Hospital of North Norway
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on October 21, 2014