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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04315532
Other study ID # 2018.06.05.1298
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date November 2016

Study information

Verified date March 2020
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date November 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 24 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-surgical periodontal treatment
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
Saliva samples were taken from patients for the evaluation of sex steroid and stress markers baseline and after 8 weeks.
GCF samples
GCF samples were taken from patients for the evaluation of stress markers baseline and after 8 weeks.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University Abant Izzet Baysal University

Outcome

Type Measure Description Time frame Safety issue
Primary Dehydroepiandrosterone (DHEA) The changes in DHEA levels within 8 weeks. Higher values represent a worse outcome. The decrease in DHEA levels is expected after periodontal treatment. Baseline and after 8 weeks
Primary estrogen The changes in estrogen levels within 8 weeks. Higher values represent a worse outcome. The decrease in estrogen levels is expected after periodontal treatment. Baseline and after 8 weeks
Secondary Gingival index 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. Baseline and after 8 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04140643 - Ozone Therapy for the Home Oral Hygiene of the Pregnant Woman. N/A
Completed NCT03336957 - Stress and Gingival Inflammation in Non-pregnant and Pregnant Women N/A