A Comparative Evaluation in Pregnant Women of the Periodontal Condition and Low Birth Delivery Incidence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 269
- Primary Endpoint
- Number of pregnancies
Study Overview
Brief Summary
The objective of this study was the evaluation of periodontal condition in pregnant women and the effect of the treatment of periodontal disease upon low birth weight.
Detailed Description
This research was carried out in the following three centers: Samsun Birth and Children's Hospital, Department of Obstetrics and Gynecology of the Faculty of Medicine and Faculty of Dentistry of the University of Ondokuz Mayıs. 269 women in their first trimester were included in this study. Their ages ranged from 18-35 years, their height was above 150 cm and they have no history of any systemic disease. At the end of each trimester these measurements were performed: attachment level, probing depth, gingival index, plaque index, and bleeding on probing. According to the periodontal diagnosis the research population was divided into three groups: periodontally healthy women; periodontally diseased women, however rejection of treatment; periodontally diseased women, however acceptance of treatment.In this study one-way ANOVA, chi-square, conditional logistic regression analyses were used.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age:18-35 years
- •Sure of her dates
Exclusion Criteria
- •systemic diseases (i.e., diabetes mellitus, cancer, hypertension, urolithiasis, parathyroid disease, diseases that compromise pregnancy)
- •Less than two pregnancy
Outcomes
Primary Outcomes
Number of pregnancies
Time Frame: At 9th months
Number of pregnancies (numbers)
Birth weight
Time Frame: At 9th months
Birth weight (kg)
Secondary Outcomes
- Probing pocket depth(average of 2nd months, 5th months and 8th months)
- Clinical attachment level(average of 2nd months, 5th months and 8th months)
- Gingival index(average of 2nd months, 5th months and 8th months)
- Plaque index(average of 2nd months, 5th months and 8th months)
- Bleeding on probing(average of 2nd months, 5th months and 8th months)
Investigators
İnci Devrim
Principal Investigator
Ondokuz Mayıs University