Periodontal DiseasesNCT03336957
Stress and Gingival Inflammation in Non-pregnant and Pregnant Women
A study testing periodontal treatment in people with Periodontal Diseases and Pregnancy Gingivitis, run by Tokat Gaziosmanpasa University.
Trial summary
Background: The purpose of the present study is to research whether stress scale scores alter with relationship to gingival inflammation and examine the impact of non-surgical periodontal therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (GCF) and on salivary stress-related hormones. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Pregnancy Gingivitis
- What is being tested?
- periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Jan 2017
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be systemically healthy;
- Must be at least twenty teeth in the mouth;
- Clinical diagnosis of gingivitis;
- Must be the probing pocket depth (PPD)≤3 mm in all four quadrants.
Who cannot join
- the use of anti-inflammatory,
- antimicrobial and hormone therapy within the preceding 6 months,
- having psychiatric disorders,
- a systemic disease,
- smoking cigarettes and
- for the control group breastfeeding, pregnancy and menstrual periods.
About this study
Official title: Effect of Non-Surgical Periodontal Therapy on Pregnancy-Related Degree of Gingival Inflammation and Stress Markers
Background: The purpose of the present study is to research whether stress scale scores alter with relationship to gingival inflammation and examine the impact of non-surgical periodontal therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (GCF) and on salivary stress-related hormones.
Methods: 30 non-pregnant (control group) and 30 pregnant women (test group) who fulfilled the study inclusion criteria were chosen. The participants with moderate/severe gingivitis were included. Clinical data and samples of GCF and salivary were collected at baseline and after periodontal therapy. The levels of cytokines interleukin-1 beta (IL-1β) and IL-10, and concentration of salivary chromogranin A (Cg A) hormone were analyzed by enzyme-linked immunosorbent assay kits.
Read the detailed description
Periodontal clinical measurements and periodontal treatment were applied by a previously trained and calibrated examiner. Clinical parameters measurements including; probing pocket depths (PPD; the distance from the gingival margin to the base of the gingival sulcus), clinical attachment level (CAL), full mouth gingival index (GI)21 and plaque index (PI)20 scores using a periodontal probe were registered following saliva and GCF sample collection. Then, non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction was applied. Clinical measurements, recruitment of GCF, and saliva samples were repeated after three weeks.
Gingival Crevicular Fluid and Saliva Sample Collection Selected anterior teeth for GCF sampling were isolated from saliva using cotton rolls, a gentle stream of air was conducted parallel to the root surface for 5 to 10 seconds to dry the area.
The periopaper strips were gently inserted into the gingival crevice until resistance was felt and were left in place for 30 s and were collected from mesio-buccal sulcus of teeth in the anterior region of each patient (two samples per patient and per visit). The samples containing blood were discarded and were placed in sterile Eppendorf tubes and were stored at -20°C until the assay procedure.
- Conditions
- Periodontal Diseases, Pregnancy Gingivitis
- Being tested
- periodontal treatment
- Keywords
- chromogranin A, stress, gingivitis, pregnancy
- Medical subject headings
- Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal treatmentProcedure or surgery
non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction
| Study group | Role | What they receive |
|---|---|---|
| Pregnant group | Experimental | Test group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment. Receives: Procedure: periodontal treatment |
| Non-Pregnant | Active comparator | Control group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment. Receives: Procedure: periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary Cg A hormone concentration
Samples should be taken before and after treatment and evaluated using ELISA kits
Measured: up to 8 weeks
Secondary outcomes (1)
IL-1β and IL-10 Cytokine levels in the GCF
Samples should be taken before and after treatment and evaluated using ELISA kits
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Jun 2016
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Gokturk, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336957
- Sponsor's protocol ID
- 15-KAEK-154
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data for all primary and secondary outcome measures will be made available.
Publications
Yarkac FU, Gokturk O, Demir O. Effect of non-surgical periodontal therapy on the degree of gingival inflammation and stress markers related to pregnancy. J Appl Oral Sci. 2018 Jul 23;26:e20170630. doi: 10.1590/1678-7757-2017-0630.
PubMed 30043934
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Therapy on Pregnancy-Related Degree of Gingival Inflammation and Stress Markers
- ClinicalTrials.gov ID
- NCT03336957
- Acronym / sponsor ID
- 15-KAEK-154
- Conditions
- Periodontal Diseases, Pregnancy Gingivitis
- Keywords
- chromogranin A, stress, gingivitis, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 8 Nov 2017 (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.
Background: The purpose of the present study is to research whether stress scale scores alter with relationship to gingival inflammation and examine the impact of non-surgical periodontal therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (GCF) and on salivary stress-related hormones.
Methods: 30 non-pregnant (control group) and 30 pregnant women (test group) who fulfilled the study inclusion criteria were chosen. The participants with moderate/severe gingivitis were included. Clinical data and samples of GCF and salivary were collected at baseline and after periodontal therapy. The levels of cytokines interleukin-1 beta (IL-1β) and IL-10, and concentration of salivary chromogranin A (Cg A) hormone were analyzed by enzyme-linked immunosorbent assay kits.
Detailed description
Periodontal clinical measurements and periodontal treatment were applied by a previously trained and calibrated examiner. Clinical parameters measurements including; probing pocket depths (PPD; the distance from the gingival margin to the base of the gingival sulcus), clinical attachment level (CAL), full mouth gingival index (GI)21 and plaque index (PI)20 scores using a periodontal probe were registered following saliva and GCF sample collection. Then, non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction was applied. Clinical measurements, recruitment of GCF, and saliva samples were repeated after three weeks.
Gingival Crevicular Fluid and Saliva Sample Collection Selected anterior teeth for GCF sampling were isolated from saliva using cotton rolls, a gentle stream of air was conducted parallel to the root surface for 5 to 10 seconds to dry the area.
The periopaper strips were gently inserted into the gingival crevice until resistance was felt and were left in place for 30 s and were collected from mesio-buccal sulcus of teeth in the anterior region of each patient (two samples per patient and per visit). The samples containing blood were discarded and were placed in sterile Eppendorf tubes and were stored at -20°C until the assay procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant group | Experimental | Procedure: periodontal treatmentTest group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment. |
| Non-Pregnant | Active comparator | Procedure: periodontal treatmentControl group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must be systemically healthy;
- Must be at least twenty teeth in the mouth;
- Clinical diagnosis of gingivitis;
- Must be the probing pocket depth (PPD)≤3 mm in all four quadrants.
Key exclusion criteria (6 listed)
- the use of anti-inflammatory,
- antimicrobial and hormone therapy within the preceding 6 months,
- having psychiatric disorders,
- a systemic disease,
- smoking cigarettes and
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 |
|---|---|---|
| periodontal treatmentnon-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction | Procedure or surgery | Non-Pregnant, Pregnant group |
Primary outcome
salivary Cg A hormone concentration
Time frame: up to 8 weeks
Samples should be taken before and after treatment and evaluated using ELISA kits
1 secondary outcome
IL-1β and IL-10 Cytokine levels in the GCF
Time frame: up to 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 8 Nov 2017.
- Derived from this study: PubMed 30043934Yarkac FU, Gokturk O, Demir O. Effect of non-surgical periodontal therapy on the degree of gingival inflammation and stress markers related to pregnancy. J Appl Oral Sci. 2018 Jul 23;26:e20170630. doi: 10.1590/1678-7757-2017-0630.
- Individual participant dataSharing planned: Undecided. individual participant data for all primary and secondary outcome measures will be made available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal treatment in people with Periodontal Diseases and 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 4 inclusion and 6 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 8 Nov 2017. 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?
salivary Cg A hormone concentration (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03336957, which also lists 1 linked publication.
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 8 Nov 2017.