Periodontal Condition in Pregnancy and Low Birth Delivery Incidence

NCT02613468 | Completed DMC

• 1 other identifier: OndokusMu
• Study Type: interventional
• Target: 269
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy; Birth Weight; Periodontal Diseases

Keywords

Pregnancy; Low birth weight; Gingivitis; Inflammation; Periodontitis

Outcome Measures

Primary Outcomes (2)

• Number of pregnancies

  Number of pregnancies (numbers)

  At 9th months

• Birth weight

  Birth weight (kg)

  At 9th months

Secondary Outcomes (5)

• Probing pocket depth

  average of 2nd months, 5th months and 8th months

• Clinical attachment level

  average of 2nd months, 5th months and 8th months

• Gingival index

  average of 2nd months, 5th months and 8th months

• Plaque index

  average of 2nd months, 5th months and 8th months

• Bleeding on probing

  average of 2nd months, 5th months and 8th months

Study Arms (3)

Periodontally healthy

PLACEBO COMPARATOR

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.

Other: collection of periodontal records; Other: pregnancy parameters

Periodontally diseased, untreated

PLACEBO COMPARATOR

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.

Other: collection of periodontal records; Other: pregnancy parameters

Periodontally diseased, treated

ACTIVE COMPARATOR

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.

Other: collection of periodontal records; Other: pregnancy parameters; Other: Initial Periodontal Therapy

Interventions

collection of periodontal records 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.

Periodontally diseased, treated; Periodontally diseased, untreated; Periodontally healthy

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.

Periodontally diseased, treated; Periodontally diseased, untreated; Periodontally healthy

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.

Periodontally diseased, treated

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age:18-35 years
• Sure of her dates

You may not qualify if:

• systemic diseases (i.e., diabetes mellitus, cancer, hypertension, urolithiasis, parathyroid disease, diseases that compromise pregnancy)
• Less than two pregnancy

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

MeSH Terms

Conditions

Birth Weight; Periodontal Diseases; Gingivitis; Inflammation; Periodontitis

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 24, 2015
• Study Start: January 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: August 1, 2005
• Last Updated: November 25, 2015

Record last verified: 2015-11