Stress and Gingival Inflammation in Non-pregnant and Pregnant Women

NCT03336957 | Completed DMC

• 1 other identifier: 15-KAEK-154
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Diseases; Pregnancy Gingivitis

Keywords

chromogranin A, stress, gingivitis, pregnancy

Outcome Measures

Primary Outcomes (1)

• salivary Cg A hormone concentration

  Samples should be taken before and after treatment and evaluated using ELISA kits

  up to 8 weeks

Secondary Outcomes (1)

• IL-1β and IL-10 Cytokine levels in the GCF

  up to 8 weeks

Study Arms (2)

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.

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.

Procedure: periodontal treatment

Interventions

periodontal treatment PROCEDURE

non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction

Non-Pregnant; Pregnant group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Related Publications (1)

• 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.

  PMID: 30043934 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 8, 2017
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11