NCT04496570

Brief Summary

The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels. A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements, GCF and saliva samples were collected from each individual at baseline and 1 month after NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 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

July 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

July 29, 2020

Last Update Submit

August 17, 2020

Conditions

Keywords

gingival crevicular fluidresolvin D1

Outcome Measures

Primary Outcomes (1)

  • Biochemical parameter (resolvin D1)

    The changes in levels of resolvin D1 after periodontal treatment determined by ELISA.

    Baseline and 1 month after NSPT

Secondary Outcomes (4)

  • Probing pocket depth

    Baseline and 1 month after NSPT

  • Clinical attachment level (CAL)

    Baseline and 1 month after NSPT

  • Plaque index (PI)

    Baseline and 1 month after NSPT

  • Gingival index (GI)

    Baseline and 1 month after NSPT

Study Arms (2)

Periodontitis patients

ACTIVE COMPARATOR

gingival crevicular fluid and saliva collection were taken before and after nonsurgical periodontal treatment

Procedure: periodontal therapy

Healthy individuals

NO INTERVENTION

gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions

Interventions

Non surgical periodontal therapy was performed to patients with peridontitis

Periodontitis patients

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Stage 3, Grade B and generalized periodontitis patients

You may not qualify if:

  • excessive forces;
  • presence of systemic diseases
  • administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months
  • having received non-surgical periodontal treatment within the past 6 months
  • allergy or sensitivity to any drug,
  • pregnancy, lactation
  • current and former use of tobacco.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

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
Principal investigator

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 3, 2020

Study Start

July 31, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations