Relationship Between LRG and Periodontal Disease

NCT ID: NCT04383561

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-02-15

Brief Summary

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This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG, interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before and after non-surgical periodontal treatment.

Detailed Description

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Twenty-five stage 3 periodontitis and twenty-five periodontally healthy individuals were enrolled in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and serum samples were obtained at baseline and at 6 weeks after treatment. LRG, IL-6 and TNF-α were determined by ELISA.

Conditions

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Periodontitis Acute-Phase Response Inflammation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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stage 3 periodontitis

GCF and serum samples were collected before and after treatment from periodontitis patients.

Group Type ACTIVE_COMPARATOR

Non-surgical periodontal treatment

Intervention Type OTHER

Scaling and root planing (SRP), in four clinical visits

Oral hygiene instructions

Intervention Type OTHER

Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.

Periodontally healthy controls

GCF and serum samples were collected from periodontally healthy controls at baseline for once.

Group Type PLACEBO_COMPARATOR

Oral hygiene instructions

Intervention Type OTHER

Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.

Interventions

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Non-surgical periodontal treatment

Scaling and root planing (SRP), in four clinical visits

Intervention Type OTHER

Oral hygiene instructions

Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 25-50 years of age
2. having at least 20 natural teeth, excluding third molars
3. having no systemic disease
4. non-smokers
5. criteria for healthy control group: BOP \< 10% and PD ≤ 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction
6. criteria for stage 3 periodontitis group: interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss extending to the mid-third of the root or beyond.

Exclusion Criteria

1. having any systemic diseases,
2. smoking
3. current pregnancy or lactation
4. a history of periodontal treatment in the past 6 months
5. using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.
Minimum Eligible Age

26 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Giresun University

OTHER

Sponsor Role collaborator

Bulent Ecevit University

OTHER

Sponsor Role collaborator

Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Pinar KELES YUCEL

Assistant Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Giresun University

Giresun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAEK-92

Identifier Type: -

Identifier Source: org_study_id

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