NCT04051385

Brief Summary

This study aimed to investigate gingival crevicular fluid (GCF) and serum ErbB4 and Nrg4 levels in periodontal health and disease. A total of 80 individuals, 20 patients with stage II grade B periodontitis, 20 patients with stage III grade B periodontitis, 20 with gingivitis and 20 periodontally healthy individuals were included. Whole-mouth and site-specific clinical periodontal parameters including probing depth, clinical attachment level, bleeding on probing, gingival index, plaque index and papillar bleeding index were recorded. GCF and serum ErbB4 and Nrg4 levels were measured by enzyme-linked immunosorbent assay. Statistical analysis was performed by using non-parametric tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

August 7, 2019

Last Update Submit

August 7, 2019

Conditions

Periodontitis

Keywords

periodontal diseasegingival crevicular fluidmacrophageErbB-4neuregulin-4

Outcome Measures

Primary Outcomes (2)

  • Biochemical parameters (ErbB4 and Nrg4)

    The changes in levels of ErbB4 and Nrg4, four weeks after periodontal treatment determined by ELISA. The changes in levels of ErbB4 and Nrg4 were analyzed to determine as a diagnostic biomarker of periodontal disease.

    Baseline and 4 weeks after treatment

  • Biochemical parameters (IL-6, IL-10, nitric oxide synthase (NOS) 2 and Arg1)

    The changes in GCF levels of IL-6 and IL-10 and serum levels of nitric oxide synthase (NOS)2 and Arg1, four weeks after periodontal treatment determined by ELISA.

    Baseline and 4 weeks after treatment

Secondary Outcomes (6)

  • Probing pocket depth

    Baseline and 4 weeks after treatment

  • Clinical attachment loss

    Baseline and 4 weeks after treatment

  • Gingival index

    Baseline and 4 weeks after treatment

  • Plaque index

    Baseline and 4 weeks after treatment

  • Bleeding on probing

    Baseline and 4 weeks after treatment

  • +1 more secondary outcomes

Study Arms (4)

stage II grade B periodontitis

ACTIVE COMPARATOR

GCF and serum samples were taken before and after treatment from stage II grade B periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)

Other: non surgical periodontal treatmentOther: Gingival crevicular fluid and serum collection

stage III grade B periodontitis

ACTIVE COMPARATOR

GCF and serum samples were taken before and after treatment from stage III grade B periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)

Other: non surgical periodontal treatmentOther: Gingival crevicular fluid and serum collection

gingivitis

ACTIVE COMPARATOR

GCF and serum samples were taken before and after treatment from gingivitis patients. Intervention: Non- surgical periodontal treatment (Scaling and oral hygiene instructions)

Other: non surgical periodontal treatmentOther: Gingival crevicular fluid and serum collection

periodontally healthy

PLACEBO COMPARATOR

GCF and serum samples were taken at baseline from periodontally healthy individuals.

Other: Gingival crevicular fluid and serum collection

Interventions

non surgical periodontal treatmentOTHER

SRP under local anaesthesia, in a total of 2 clinical visits. Oral hygiene instructions including the modified Bass technique and an appropriate interdental cleaning device with dental floss and interdental brush.

gingivitisstage II grade B periodontitisstage III grade B periodontitis
Gingival crevicular fluid and serum collectionOTHER

GCF with filter paper using the intracrevicular method and serum collection

gingivitisperiodontally healthystage II grade B periodontitisstage III grade B periodontitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged \>18 years,
  • Having at least 16 natural teeth (excluding third molar),
  • Not having any diagnosed medical illness or drug intake that could affect the periodontal condition.

You may not qualify if:

  • Patients who had taken antibiotics, nonsteroidal antiinflammatory or any other drugs within the past 3 months,
  • Patients received nonsurgical or surgical periodontal treatment,
  • Patients who have a restorative and endodontic therapy requirement,
  • Having a removable partial denture and/or having orthodontic therapy,
  • Current pregnancy or lactation,
  • Obesity,
  • Heavy smoking and having serum CRP \> 3mg/L .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

Related Publications (2)

  • Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

    PMID: 29926951BACKGROUND

  • Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Clin Periodontol. 2018 Jun;45 Suppl 20:S1-S8. doi: 10.1111/jcpe.12935.

    PMID: 29926489BACKGROUND

MeSH Terms

Conditions

PeriodontitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Sadiye Gunpinar, Asst. Prof.

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

April 2, 2018

Primary Completion

January 18, 2019

Study Completion

January 18, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

TU(1)