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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01675180
Other study ID # 2012/633/REK nord
Secondary ID
Status Recruiting
Phase N/A
First received August 27, 2012
Last updated February 9, 2018
Start date February 2013
Est. completion date October 2019

Study information

Verified date February 2017
Source University of Tromso
Contact Ganesh Acharya, Professor
Phone 77626432
Email ganesh.acharya@uit.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Information
Women in the intervention group will recieve information and counseling on oral health care during pregnancy
Control
No intervention

Locations

Country Name City State
Norway Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN) Tromsø Troms

Sponsors (2)

Lead Sponsor Collaborator
University of Tromso University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oral health Streptococcus Mutans, lactobacilli In 4 weeks interval after recrutiatment of study participants
Secondary Attitude Attitude towards oral health care After approximately 6 months
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