Periodontal Condition in Pregnancy and Low Birth Delivery Incidence

NCT ID: NCT02613468

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Birth Weight Periodontal Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

collection of periodontal records

Intervention Type OTHER

1. Clinic attachment level
2. Probing depth
3. Gingival index
4. Plaque index
5. Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.

pregnancy parameters

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

collection of periodontal records

Intervention Type OTHER

1. Clinic attachment level
2. Probing depth
3. Gingival index
4. Plaque index
5. Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.

pregnancy parameters

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

collection of periodontal records

Intervention Type OTHER

1. Clinic attachment level
2. Probing depth
3. Gingival index
4. Plaque index
5. Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.

pregnancy parameters

Intervention Type OTHER

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.

Initial Periodontal Therapy

Intervention Type OTHER

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.

Interventions

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collection of periodontal records

1. Clinic attachment level
2. Probing depth
3. Gingival index
4. Plaque index
5. Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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İnci Devrim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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OndokusMu

Identifier Type: -

Identifier Source: org_study_id