Periodontal Condition in Pregnancy and Low Birth Delivery Incidence

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613468
• Other study ID #: OndokusMu
• Status: Completed
• Phase: N/A
• First received: November 13, 2015
• Last updated: November 23, 2015
• Start date: January 2004
• Est. completion date: August 2005

Study information

• Verified date: November 2015
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: August 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Gingival Diseases
• Periodontal Diseases
• Pregnancy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pregnancies	Number of pregnancies (numbers)	At 9th months	No
Primary	Birth weight	Birth weight (kg)	At 9th months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No