Periodontal Condition in Pregnancy and Low Birth Delivery Incidence

A Comparative Evaluation in Pregnant Women of the Periodontal Condition and Low Birth Delivery Incidence

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Pregnancy; Birth Weight
• Intervention / Treatment: Other: collection of periodontal records; Other: pregnancy parameters; Other: Initial Periodontal Therapy

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 Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Periodontally healthy; Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester. Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated. Intervation: Collection of periodontal records and pregnancy parameters.	Other: collection of periodontal records; Clinic attachment level; Probing depth; Gingival index; Plaque index; Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.; Other: pregnancy parameters; Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.
Placebo Comparator: Periodontally diseased, untreated; This group is comprised of individuals who do not accept treatment Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester. Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit were evaluated. Birth weight was recorded at the end of pregnancy.	Other: collection of periodontal records; Clinic attachment level; Probing depth; Gingival index; Plaque index; Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.; Other: pregnancy parameters; Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.
Active Comparator: Periodontally diseased, treated; This group is comprised of individuals who agree to treatment. Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester. Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit were evaluated. Initial Periodontal Therapy is completed (calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester. Birth weight was recorded at the end of pregnancy. Intervation: Collection of periodontal records and pregnancy parameters.	Other: collection of periodontal records; Clinic attachment level; Probing depth; Gingival index; Plaque index; Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.; Other: pregnancy parameters; Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.; Other: Initial Periodontal Therapy; Initial Periodontal Therapy is completed ( Supragingival and subgingival calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pregnancies	Number of pregnancies (numbers)	At 9th months
Birth weight	Birth weight (kg)	At 9th months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth	The changes in probing pocket depth in time frame.Probing pocket depth was measured for determining severity of disease and clinic outcome.	average of 2nd months, 5th months and 8th months
Clinical attachment level	The changes in clinical attachment level in time frame. Clinical attachment level was measured for determining severity of disease and clinic outcome.	average of 2nd months, 5th months and 8th months
Gingival index	The changes in gingival index in time frame. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.	average of 2nd months, 5th months and 8th months
Plaque index	The changes in plaque index in time frame. Plaque index was recorded for determining and classifying oral hygiene status.	average of 2nd months, 5th months and 8th months
Bleeding on probing	The changes in bleeding on probing in time frame. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.	average of 2nd months, 5th months and 8th months

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 21, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Estimate): November 25, 2015
• Last Update Submitted That Met QC Criteria: November 23, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Inflammation; Pregnancy; Periodontitis; Low birth weight; Gingivitis
• Additional Relevant MeSH Terms: Body Weight; Stomatognathic Diseases; Mouth Diseases; Birth Weight; Periodontal Diseases
• Other Study ID Numbers: OndokusMU