Skip to main content
OpenTrials
Completed

NCT Number: NCT02613468

Periodontal Condition in Pregnancy 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Birth Weight Body Weight Gingival Diseases Gingivitis Infections Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Signs and Symptoms Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collection of periodontal records

Other
  • 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.

pregnancy parameters

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

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.

Primary outcomes

  1. Number of pregnancies

    Time frame: At 9th months

    Number of pregnancies (numbers)

  2. Birth weight

    Time frame: At 9th months

    Birth weight (kg)

Secondary outcomes

  1. Probing pocket depth

    Time frame: 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.

  2. Clinical attachment level

    Time frame: 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.

  3. Gingival index

    Time frame: 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.

  4. Plaque index

    Time frame: 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.

  5. Bleeding on probing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2005
First posted
Nov 24, 2015
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.