Stress and Gingival Inflammation in Non-pregnant and Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Pregnancy Gingivitis
• Intervention / Treatment: Procedure: periodontal treatment

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Must be systemically healthy;
2. Must be at least twenty teeth in the mouth;
3. Clinical diagnosis of gingivitis;
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant group; 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.	Procedure: periodontal treatment; non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction
Active Comparator: Non-Pregnant; 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.	Procedure: periodontal treatment; non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary Cg A hormone concentration	Samples should be taken before and after treatment and evaluated using ELISA kits	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-1β and IL-10 Cytokine levels in the GCF	Samples should be taken before and after treatment and evaluated using ELISA kits	up to 8 weeks

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: chromogranin A, stress, gingivitis, pregnancy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Inflammation; Gingivitis; Periodontal Diseases
• Other Study ID Numbers: 15-KAEK-154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: individual participant data for all primary and secondary outcome measures will be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No