NCT02433405

Brief Summary

The purpose of this study was to evaluate acute phase proteins (APPs) Fetuin-A and Serum Amyloid A (SAA) levels in gingival crevicular fluid (GCF) and serum samples in periodontal health and disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

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

December 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

April 24, 2015

Last Update Submit

April 29, 2015

Conditions

Keywords

Serum Amyloid AFetuin-Agingival crevicular fluidserumperiodontal diseases

Outcome Measures

Primary Outcomes (1)

  • Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF

    Day 0

Secondary Outcomes (1)

  • Fetuin-A levels as an inflammatory marker in periodontal disease both in serum and GCF

    Day 0

Study Arms (3)

Group 1

Chronic Periodontitis-serum amyloid A, Fetuin-A

Biological: Fetuin-ABiological: Serum Amyloid A

Group 2

Plaque induced Gingivitis-serum amyloid A, Fetuin-A

Biological: Fetuin-ABiological: Serum Amyloid A

Group 3

Control Group-serum amyloid A, Fetuin-A

Biological: Fetuin-ABiological: Serum Amyloid A

Interventions

Fetuin-ABIOLOGICAL

Acute phase protein

Group 1Group 2Group 3
Serum Amyloid ABIOLOGICAL

Acute phase protein

Group 1Group 2Group 3

Eligibility Criteria

Age28 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population consisted totally 60 subjects whose age (28-45) and sex (33 men, 27 female) were matched.

You may qualify if:

  • GI\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
  • Systematically healthy patients
  • No alveolar bone and attachment loss
  • Inflammation signs such as redness, edema and increased BOP levels,
  • GI≥2, PPD≤3mm, CAL≤3mm.
  • Systematically healthy patients
  • No bone and attachment loss,
  • GI=0, PPD≤3mm, CAL≤3mm
  • Systematically healthy patients

You may not qualify if:

  • Aggressive Periodontitis,
  • Oral pathologies,
  • Patients with any other systemic diseases,
  • Pregnant women and those in the lactation period,
  • Patients with smoking habit and taking medication
  • Patients received periodontal therapy in last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid and Serum

MeSH Terms

Conditions

Periodontal Diseases

Interventions

alpha-2-HS-GlycoproteinSerum Amyloid A Protein

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesFetuinsAlpha-GlobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsCalcium-Binding ProteinsCarrier ProteinsCystatinsGlobulinsAmyloidogenic ProteinsAmyloidAcute-Phase Proteins

Study Officials

  • ÇİĞDEM COŞKUN TÜRER, PhD

    BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 5, 2015

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

May 5, 2015

Record last verified: 2015-04