Periodontal Condition in Pregnancy and Low Birth Delivery Incidence

Not Applicable

Completed

• Conditions: Pregnancy; Birth Weight; Periodontal Diseases
• Interventions: Other: collection of periodontal records; Other: pregnancy parameters; Other: Initial Periodontal Therapy

• Registration Number: NCT02613468
• Lead Sponsor: Ondokuz Mayıs University

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2004-12
• Study Completion: 2005-08
• Status Verified: 2015-11
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-21
• Last Update Submitted: 2015-11-23
• Study First Posted: 2015-11-24
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 269

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Periodontally healthy	pregnancy parameters	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.
Periodontally diseased, treated	Initial Periodontal Therapy	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.
Periodontally healthy	collection of periodontal records	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.
Periodontally diseased, untreated	collection of periodontal records	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.
Periodontally diseased, untreated	pregnancy parameters	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.
Periodontally diseased, treated	collection of periodontal records	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.
Periodontally diseased, treated	pregnancy parameters	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.

Primary Outcome Measures

Name	Time	Method
Number of pregnancies	At 9th months	Number of pregnancies (numbers)
Birth weight	At 9th months	Birth weight (kg)

Secondary Outcome Measures

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