NCT04383561

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 4, 2020

Last Update Submit

May 7, 2020

Conditions

Keywords

periodontitisgingival crevicular fluidserum

Outcome Measures

Primary Outcomes (1)

  • Changes in the levels of biochemical parameters

    The levels LRG, IL-6 and TNF-α were determined to define the diagnostic and prognostic potential as a biomarker in periodontitis.

    Baseline and 6 weeks after treatment

Study Arms (2)

stage 3 periodontitis

ACTIVE COMPARATOR

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

Other: Non-surgical periodontal treatmentOther: Oral hygiene instructions

Periodontally healthy controls

PLACEBO COMPARATOR

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

Other: Oral hygiene instructions

Interventions

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

stage 3 periodontitis

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

Periodontally healthy controlsstage 3 periodontitis

Eligibility Criteria

Age26 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • having at least 20 natural teeth, excluding third molars
  • having no systemic disease
  • non-smokers
  • criteria for healthy control group: BOP \< 10% and PD ≤ 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction
  • 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.

You may not qualify if:

  • having any systemic diseases,
  • smoking
  • current pregnancy or lactation
  • a history of periodontal treatment in the past 6 months
  • using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun University

Giresun, 28100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisAcute-Phase ReactionInflammation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof.

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 12, 2020

Study Start

September 30, 2019

Primary Completion

January 15, 2020

Study Completion

February 15, 2020

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations