NCT06076941

Brief Summary

The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

Same day

First QC Date

September 24, 2023

Last Update Submit

October 4, 2023

Conditions

Keywords

Prengnancyoral and dental healthEducationknowledge and behavior

Outcome Measures

Primary Outcomes (4)

  • Form for Assessment of Knowledge Levels of Pregnant Women Regarding Oral and Dental Health

    This form was developed by the researcher by reviewing the literature to determine the knowledge levels of pregnant women about oral and dental health and their educational needs in this direction. The form includes 22 questions assessing the importance of dietary habits for oral and dental health, visiting a dentist during pregnancy, dental and gum treatment during pregnancy, and dental x-rays during pregnancy. The form is evaluated by giving "1 point" for correct answers and "0 point" for incorrect answers in line with the answer key specified in Appendix 4. The lowest score that can be obtained from the form is 0 and the highest score is 22. High scores indicate a high level of knowledge.

    up to 24 weeks

  • Form for Assessment of Oral and Dental Health Behaviors of Pregnant Women

    This form was developed by the researcher by reviewing the literature to determine the oral and dental health behaviors of pregnant women. The form consists of 16 questions evaluating the behaviors of pregnant women such as current dental health status, frequency of tooth brushing, tooth brushing technique, fluoride toothpaste use, frequency of flossing and frequency of toothbrush replacement.

    up to 24 weeks

  • Pregnant Women's Education Satisfaction Evaluation Form

    This form was prepared by the researcher to evaluate the effectiveness and benefits of the training and the opinions of the pregnant women in the experimental group after the training.

    up to 24 weeks

  • Descriptive Information Form

    This form was developed by the researcher and consisted of two parts: sociodemographic characteristics and obstetric characteristics of pregnant women. Sociodemographic characteristics included questions such as age, education level, employment status, spouse's employment status, income level and family type. Obstetric characteristics included information on the number of pregnancies, number of living children and gestational week. There are 14 questions in the descriptive information form

    up to 24 weeks

Study Arms (2)

Education

EXPERIMENTAL

Pregnant women in the experimental group were given oral and dental health education in groups of maximum five, and the forms were filled out before and one month after the education.

Other: Education

Control

NO INTERVENTION

No intervention was made to the pregnant women in the control group, and the forms were completed before and one month after the training.

Interventions

Before the training was given to the pregnant women in the experimental group who agreed to participate in the study, the Introductory Information Form, the Form for Assessing Pregnant Women's Behaviors Towards Oral and Dental Health, and the Form for Assessing Pregnant Women's Knowledge Levels Towards Oral and Dental Health were applied by face-to-face interview method. The application of the forms took 20-30 minutes. Then, a training time was planned on a suitable date for the pregnant women. In order to ensure the effectiveness of the training, to answer the questions of the pregnant women effectively and to be able to direct them to the dentist in line with their needs, the training was applied in groups of maximum five people. Lecture, question and answer and demonstration methods were used in the training. One month after the training, the necessary forms were applied to the pregnant women and the study was terminated.

Education

Eligibility Criteria

Age19 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being in the first trimester of pregnancy
  • Being 19-44 years old,
  • Being able to read and write turkish,
  • Being a healthy pregnant woman who agrees to participate in the study

You may not qualify if:

  • Having a risky pregnancy,
  • Can't speak or understand Turkish
  • Women with intellectual disability
  • Serious mental disorders will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Tarsus, Takbaş, 33400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behavior

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Özlem DURAN AKSOY

    Cumhuriyet University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels. With the power analysis, α = 0.05, β = 0.20, 1-β = 0.80, a total of 60 pregnant women, 30 in the experimental group and 30 in the control group were included (the power of the test was found as p = 0.8056).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 24, 2023

First Posted

October 11, 2023

Study Start

April 15, 2017

Primary Completion

April 15, 2017

Study Completion

October 14, 2020

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations