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CompletedNCT04315532Updated Mar 23, 2020

The Effect of Periodontal Treatment on Stress and Pregnancy Relationship

An interventional study of Non-surgical periodontal treatment and Saliva samples in Pregnancy Gingivitis, sponsored by Tokat Gaziosmanpasa University. Completed. Open to female participants aged 24 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-23.

Sponsored by Tokat Gaziosmanpasa University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Apr 2016, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Non-randomized
Ages
24 Years to 50 Years
Sex
Female
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Pregnancy Gingivitis

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Keywords

  • Stress
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 84 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Tokat Gaziosmanpasa University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Active comparator
    Pregnancy Group

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

    Other: Non-surgical periodontal treatment · Other: Saliva samples · Other: GCF samples

  • Active comparator
    Non-Pregnancy Group

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

    Other: Non-surgical periodontal treatment · Other: Saliva samples · Other: GCF samples

Interventions

  • OtherNon-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.

  • OtherSaliva samples

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

  • OtherGCF samples

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and after 8 weeks

  2. 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.

    Time frame: Baseline and after 8 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and after 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04315532
Lead sponsor
Tokat Gaziosmanpasa University
Collaborators
Abant Izzet Baysal University
Responsible party
Ozge Gokturk (Principal Investigator, Tokat Gaziosmanpasa University) — Principal investigator
First posted
Mar 19, 2020
Start date
Apr 2016
Primary completion
Oct 2016
Completion
Nov 2016
Last update
Mar 23, 2020

Study contacts

Ozge Gokturk
principal investigator · Abant Izzet Baysal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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