Stress and Gingival Inflammation in Non-pregnant and Pregnant Women
Primary Purpose
Periodontal Diseases, Pregnancy Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring chromogranin A, stress, gingivitis, pregnancy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pregnant group
Non-Pregnant
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
salivary Cg A hormone concentration
Samples should be taken before and after treatment and evaluated using ELISA kits
Secondary Outcome Measures
IL-1β and IL-10 Cytokine levels in the GCF
Samples should be taken before and after treatment and evaluated using ELISA kits
Full Information
NCT ID
NCT03336957
First Posted
November 2, 2017
Last Updated
November 6, 2017
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT03336957
Brief Title
Stress and Gingival Inflammation in Non-pregnant and Pregnant Women
Official Title
Effect of Non-Surgical Periodontal Therapy on Pregnancy-Related Degree of Gingival Inflammation and Stress Markers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (undefined)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Pregnancy Gingivitis
Keywords
chromogranin A, stress, gingivitis, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnant group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Pregnant
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
periodontal treatment
Intervention Description
non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction
Primary Outcome Measure Information:
Title
salivary Cg A hormone concentration
Description
Samples should be taken before and after treatment and evaluated using ELISA kits
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
IL-1β and IL-10 Cytokine levels in the GCF
Description
Samples should be taken before and after treatment and evaluated using ELISA kits
Time Frame
up to 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
individual participant data for all primary and secondary outcome measures will be made available.
Citations:
PubMed Identifier
30043934
Citation
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.
Results Reference
derived
Learn more about this trial
Stress and Gingival Inflammation in Non-pregnant and Pregnant Women
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