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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01652300
Other study ID # MUMS
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received July 17, 2012
Last updated July 27, 2012
Start date June 2008
Est. completion date December 2008

Study information

Verified date July 2012
Source Gonabad University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

Periodontal diseased during pregnancy are associated with many unpleasant prenatal consequences including preeclampsia, preterm labor, and low birth weight (LBW). Treatment of such diseases and observance of oral and dental hygiene may to some large extent prevent such consequences. Unfortunately previous studies have shown that pregnant women have very little knowledge of oral and dental health implications. Given the fact that pregnancy my be a unique opportunity to initiate correct hygienic behaviors in young women, this paper has focused on studying the effects of oral and dental health education during pregnancy.

In this single blind clinical trial study,140 pregnant women receiving care from Khaje Rabi Regional Health Center in Mashhad city who were members of a community based multi-center were chosen by systematic clustering methods and randomly allocated into test and control groups. After intervention, two questionnaires were completed for demographic and pregnancy details of the participants. Knowledge, health belief and health behavior were assessed before intervention. The test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy. women in the control group received no education. Knowledge, health belief and health behavior were assessed immediately after and one month after intervention of all participants. Analysis of data was done using SPSS, t-test and chi-square tests.


Description:

In this clinical trial study,140 pregnant women receiving care from Khaje Rabi Regional Health Center in Mashhad city who were members of a community based multi-center were chosen by systematic clustering methods and randomly allocated into test and control groups. After intervention, two questionnaires were completed for demographic and pregnancy details of the participants. Knowledge, health belief and health behavior were assessed before intervention. The test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy. women in the control group received no education. Knowledge, health belief and health behavior were assessed immediately after and one month after intervention of all participants. Analysis of data was done using SPSS, t-test and chi-square tests.


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Spoke Persian

- minimum education margin of primary school studies

- Gestational age between 12 and 32 weeks

- lacked any type of physical or mental problem

- lacked of any disease that could prevent from taking dental care

Exclusion Criteria:

- who did not attend the education sessions

- failed to complete the questionnaires

- receive any special education between post-test and stability test

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
two educational sessions
The test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy
no education
women in the control group received no education

Locations

Country Name City State
Iran, Islamic Republic of Mums Mashhad Khorasan Razavi

Sponsors (2)

Lead Sponsor Collaborator
Gonabad University of Medical Sciences Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score of KAP about oral health 2 months Yes
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