NCT03558906

Brief Summary

This study aimed to investigate gingival crevicular fluid (GCF) and salivary hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumor necrosis factor-alpha (TNF-α) levels in different periodontal diseases. A total of 87 individuals, 20 patients with generalized aggressive periodontitis, 20 with chronic periodontitis, 26 with gingivitis and 21 periodontally healthy individuals were included. Whole-mouth and site-specific clinical periodontal parameters including probing depth, clinical attachment level, bleeding on probing, gingival index and plaque index were recorded. GCF and salivary HIF-1α, VEGF and TNF-α levels were measured by enzyme-linked immunosorbent assay. Statistical analysis was performed by using non-parametric tests.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

1 day

First QC Date

May 23, 2018

Last Update Submit

June 14, 2018

Conditions

Keywords

Periodontal diseaseHypoxiaCytokinesGingival crevicular fluidSaliva

Outcome Measures

Primary Outcomes (1)

  • Gingival crevicular fluid HIF-1α levels

    pg

    A day after clinical periodontal examination

Secondary Outcomes (3)

  • Salivary HIF-1α levels

    A day after clinical periodontal examination

  • Gingival crevicular fluid VEGF levels

    A day after clinical periodontal examination

  • Salivary VEGF levels

    A day after clinical periodontal examination

Study Arms (4)

Aggressive Periodontitis

These individuals had minimum PD ≥6 mm and CAL ≥5 mm on eight or more teeth; at least three of these were other than central incisors or first molars. Radiographic alveolar bone loss was ≥30% of root length affecting at least three permanent teeth other than first molars and incisors. The severe destruction pattern was not commensurate with amount of plaque accumulation.

Chronic periodontitis

These individuals had at least four non-adjacent teeth with sites with PD ≥6 mm and CAL ≥5 mm. They had also ≥50% alveolar bone loss in at least two quadrants that was commensurate with amount of plaque accumulation. BOP was \>50% in the whole mouth.

Gingivitis

Gingivitis patients exhibited no sites with CAL \>2 mm and no detectable alveolar bone loss in the radiography. BOP was \>50% in the whole mouth.

Healthy

Periodontally healthy volunteers exhibited no sites with PD \>3 mm and CAL \>2 mm as well as no radiographic evidence of alveolar bone loss. BOP was \<15% in the whole mouth.

Eligibility Criteria

Age27 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All consecutive individuals were recruited from the Department of Periodontology, School of Dentistry, Adnan Menderes University, Aydın.

You may qualify if:

  • Systemically healthy individuals
  • Non-smoker individuals

You may not qualify if:

  • Current pregnancy or lactation
  • Nonsurgical/surgical periodontal treatment received for the past year
  • Use of anti-inflammatory and antibiotic drugs within the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid, saliva

MeSH Terms

Conditions

Periodontal DiseasesHypoxia

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 15, 2018

Study Start

March 1, 2016

Primary Completion

March 2, 2016

Study Completion

December 26, 2016

Last Updated

June 15, 2018

Record last verified: 2018-06