NCT04315532

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 18, 2020

Last Update Submit

March 19, 2020

Conditions

Pregnancy Gingivitis

Keywords

Stress

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Gingival index

    Baseline and after 8 weeks

Study Arms (2)

Pregnancy Group

ACTIVE COMPARATOR

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 treatmentOther: Saliva samplesOther: GCF samples

Non-Pregnancy Group

ACTIVE COMPARATOR

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 treatmentOther: Saliva samplesOther: GCF samples

Interventions

Non-surgical periodontal treatmentOTHER

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.

Non-Pregnancy GroupPregnancy Group
Saliva samplesOTHER

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

Non-Pregnancy GroupPregnancy Group
GCF samplesOTHER

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

Non-Pregnancy GroupPregnancy Group

Eligibility Criteria

Age24 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ozge Gokturk

    Abant Izzet Baysal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 19, 2020

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

March 23, 2020

Record last verified: 2020-03