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Completed

NCT Number: NCT04315532

The Effect of Periodontal Treatment on Stress and Pregnancy Relationship

There is a relationship between stress and pregnancy gingivitis. This relationship may be double-sided.

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Key information

Conditions

Pregnancy Gingivitis

Age range

24 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The aim of this clinical study was to determine the effect of non-surgical mechanical periodontal treatment on sex steroid and stress markers at pregnancy gingivitis. A total of 84 subjects; 22 pregnant women with gingivitis (group 1) and 25 pregnant women with periodontal healthy (pregnant group), group 2), 22 non-pregnant women with gingivitis (group 3) and 15 non-pregnant women with periodontal healthy (non-pregnant group), group 4) participated in this study. Clinically, plaque index, gingival index, and probing pocket depth were measured at baseline and after therapy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • being between the ages of 24-50
  • being pregnant for 23-30 weeks (for pregnant individuals)
  • not smoking.

Exclusion criteria

  • using antimicrobial or anti-inflammatory therapy within the previous 3 months,
  • having systemic disease,
  • having periodontitis,
  • having deep caries lesions, and remnant roots and
  • having lactation

Treatment and study plan

Non-surgical periodontal treatment

Other

Non-surgical periodontal treatment was performed for pregnant and non-pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken from all patients baseline and after 8 weeks.

Saliva Samples

Other

Saliva samples were taken from patients for the evaluation of sex steroid and stress markers baseline and after 8 weeks.

GCF samples

Other

GCF samples were taken from patients for the evaluation of stress markers baseline and after 8 weeks.

Primary outcomes

  1. Dehydroepiandrosterone (DHEA)

    Time frame: Baseline and after 8 weeks

    The changes in DHEA levels within 8 weeks. Higher values represent a worse outcome. The decrease in DHEA levels is expected after periodontal treatment.

  2. estrogen

    Time frame: Baseline and after 8 weeks

    The changes in estrogen levels within 8 weeks. Higher values represent a worse outcome. The decrease in estrogen levels is expected after periodontal treatment.

Secondary outcomes

  1. Gingival index

    Time frame: Baseline and after 8 weeks

    The changes in gingival index level after periodontal treatment. Gingival index was measured for determining the severity of disease and clinical outcome. Higher values represent a worse outcome. After periodontal treatment, a reduction in gingival index value is expected.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Collaborators

  • Abant Izzet Baysal University

Registry information

Official study title

Relationship of Sex Steroid and Stress Markers in Saliva and Gingival Crevicular Fluid With Pregnancy

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2020
Registry last updated
Mar 23, 2020

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.

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