Periodontal Condition in Pregnancy and Low Birth Delivery Incidence

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

collection of periodontal records

pregnancy parameters

Initial Periodontal Therapy

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Pregnancy, Low birth weight, Gingivitis, Inflammation, Periodontitis

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Periodontally healthy

Periodontally diseased, untreated

Periodontally diseased, treated

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of pregnancies

Number of pregnancies (numbers)

Birth weight

Birth weight (kg)

Secondary Outcome Measures

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.

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.

Gingival index

The changes in gingival index in time frame. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.

Plaque index

The changes in plaque index in time frame. Plaque index was recorded for determining and classifying oral hygiene status.

Bleeding on probing

The changes in bleeding on probing in time frame. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.

Full Information

NCT ID

NCT02613468

First Posted

November 13, 2015

Last Updated

November 23, 2015

Sponsor

Ondokuz Mayıs University

1. Study Identification

Unique Protocol Identification Number

NCT02613468

Brief Title

Periodontal Condition in Pregnancy and Low Birth Delivery Incidence

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ondokuz Mayıs University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy, Birth Weight, Periodontal Diseases

Keywords

Pregnancy, Low birth weight, Gingivitis, Inflammation, Periodontitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

269 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Periodontally healthy

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Periodontally diseased, untreated

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Periodontally diseased, treated

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

collection of periodontal records

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

pregnancy parameters

Intervention Description

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

Intervention Name(s)

Initial Periodontal Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of pregnancies

Description

Number of pregnancies (numbers)

Time Frame

At 9th months

Title

Birth weight

Description

Birth weight (kg)

Time Frame

At 9th months

Secondary Outcome Measure Information:

Title

Probing pocket depth

Description

The changes in probing pocket depth in time frame.Probing pocket depth was measured for determining severity of disease and clinic outcome.

Time Frame