Self Reported Oral Health, Awareness and Attitude Towards Dental Care Among Pregnant Women
This study is not yet open for participant recruitment.
Verified May 2012 by University of Tromso
Sponsor:
University of Tromso
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
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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:
- 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.
| 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
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 May 21, 2013