Pregnancy GingivitisNCT04315532
The Effect of Periodontal Treatment on Stress and Pregnancy Relationship
A study testing Non-surgical periodontal treatment, Saliva samples and GCF samples in people with Pregnancy Gingivitis, run by Tokat Gaziosmanpasa University.
Trial summary
There is a relationship between stress and pregnancy gingivitis. This relationship may be double-sided. Read more about this study
- Who is it for?
- Ages 24 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Gingivitis
- What is being tested?
- Non-surgical periodontal treatment, Saliva samples and GCF samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being between the ages of 24-50
- being pregnant for 23-30 weeks (for pregnant individuals)
- not smoking.
Who cannot join
- 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
About this study
Official title: Relationship of Sex Steroid and Stress Markers in Saliva and Gingival Crevicular Fluid With Pregnancy
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.
- Conditions
- Pregnancy Gingivitis
- Being tested
- Non-surgical periodontal treatment, Saliva samples, GCF samples
- Keywords
- Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Saliva samplesOther
Saliva samples were taken from patients for the evaluation of sex steroid and stress markers baseline and after 8 weeks.
GCF samplesOther
GCF samples were taken from patients for the evaluation of stress markers baseline and after 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-surgical periodontal treatment; Other: Saliva samples; Other: 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. Receives: Other: Non-surgical periodontal treatment; Other: Saliva samples; Other: GCF samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study startApr 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Collaborators
- Abant Izzet Baysal University
- Responsible party
- Principal investigator, Ozge Gokturk, Tokat Gaziosmanpasa University
- Investigators
- Ozge Gokturk, Principal investigator, Abant Izzet Baysal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315532
- Sponsor's protocol ID
- 2018.06.05.1298
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Sex Steroid and Stress Markers in Saliva and Gingival Crevicular Fluid With Pregnancy
- ClinicalTrials.gov ID
- NCT04315532
- Acronym / sponsor ID
- 2018.06.05.1298
- Conditions
- Pregnancy Gingivitis
- Keywords
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Collaborators
- Abant Izzet Baysal University
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a relationship between stress and pregnancy gingivitis. This relationship may be double-sided.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancy Group | Active comparator | Other: Non-surgical periodontal treatment, Other: Saliva samples, Other: GCF samplesGCF 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. |
| Non-Pregnancy Group | Active comparator | Other: Non-surgical periodontal treatment, Other: Saliva samples, Other: GCF samplesGCF 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. |
Who may qualify
- Ages
- 24 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being between the ages of 24-50
- being pregnant for 23-30 weeks (for pregnant individuals)
- not smoking.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal treatmentNon-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. | Other | Non-Pregnancy Group, Pregnancy Group |
| Saliva samplesSaliva samples were taken from patients for the evaluation of sex steroid and stress markers baseline and after 8 weeks. | Other | Non-Pregnancy Group, Pregnancy Group |
| GCF samplesGCF samples were taken from patients for the evaluation of stress markers baseline and after 8 weeks. | Other | Non-Pregnancy Group, Pregnancy Group |
Primary outcome
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.
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.
1 secondary outcome
Gingival index
Time frame: Baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozge Gokturk principal investigator
Abant Izzet Baysal
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment, Saliva samples and GCF samples in people with Pregnancy Gingivitis, run by Tokat Gaziosmanpasa University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dehydroepiandrosterone (DHEA) (time frame: Baseline and after 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.