NCT04020315

Brief Summary

Hypoxia-inducible angiogenic pathway involving hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumour necrosis factor- alpha (TNF-α) may regulate the several biological processes related to inflammation. Generalized aggressive periodontitis (G-AgP) is a rare but highly destructive form of inflammatory periodontal disease. The present study aimed to assess the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF) HIF-1α, VEGF and TNF-α levels in G-AgP patients. 20 G-AgP and 20 periodontally healthy subjects were enrolled. At baseline, GCF samples were collected and whole mouth clinical periodontal parameters were recorded. G-AgP patients received non-surgical periodontal treatment. Clinical parameters and GCF cytokines were re-measured at 1 and 3 months after treatment. GCF HIF-1α, VEGF and TNF-α levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

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

December 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

July 12, 2019

Last Update Submit

July 15, 2019

Conditions

Keywords

aggressive periodontitisgingival crevicular fluidhypoxiacytokines

Outcome Measures

Primary Outcomes (1)

  • Gingival crevicular fluid protein content change

    pg/ml

    Change from baseline to 1 month and 3 months after treatment

Study Arms (1)

Generalized aggressive periodontitis

EXPERIMENTAL

Non-surgically performed scaling and root planing.

Procedure: Non-surgically performed scaling and root planing

Interventions

Non-surgically performed scaling and root planing

Generalized aggressive periodontitis

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 25 to 45 years
  • non-smokers with no history of smoking
  • having at least 20 natural teeth.

You may not qualify if:

  • having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
  • usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
  • having any non-inflammatory destructive periodontal disease
  • nonsurgical/surgical periodontal therapy received in the past year
  • having a restorative and endodontic treatment requirement
  • having orthodontic appliances or a removable partial denture
  • pregnant/ lactating/ postmenopausal females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University, Faculty of Dentistry, Department of Periodontology

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Aggressive PeriodontitisHypoxia

Interventions

Root Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 16, 2019

Study Start

December 1, 2017

Primary Completion

August 30, 2018

Study Completion

September 15, 2018

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations