NCT04540328

Brief Summary

The study evaluates the influence of non-surgical mechanical periodontal treatment in patients with severe chronic periodontitis on inflammatory markers related to risk for cardiovascular diseases

Trial Health

100
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 Aug 2015

Typical duration for not_applicable

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

August 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

March 7, 2018

Last Update Submit

September 1, 2020

Conditions

Keywords

asymmetric dimethylarginineendothelial nitric oxide synthasehomocysteinemonocyte chemoattractant protein-1

Outcome Measures

Primary Outcomes (4)

  • Asymmetric dimethylarginine (ADMA)

    Serum Concentration (pg/mL)

    At the 3rd months after non-surgical periodontal treatment

  • Endothelial nitric oxide synthase (eNOS)

    Serum Concentration (pg/mL)

    At the 3rd months after non-surgical periodontal treatment

  • Homocysteine (Hcy)

    Serum Concentration (nmol/mL)

    At the 3rd months after non-surgical periodontal treatment

  • Monocyte chemoattractant protein-1 (MCP-1)

    Serum Concentration (ng/mL)

    At the 3rd months after non-surgical periodontal treatment

Secondary Outcomes (1)

  • Clinical periodontal parameter

    At the 3rd months after non-surgical periodontal treatment

Study Arms (1)

Non-surgical peridontal treatment

OTHER

Patients with chronic periodontitis received non-surgical periodontal treatment, including scaling and root planing and polishing within 14 days under local anesthesia with manual and ultrasonic devices and standardized oral hygiene instructions including methods of tooth-brushing and interdental cleaning were also given to each one. A professional supragingival plaque control was applied on a regular basis every month.

Other: Non-surgical periodontal treatment

Interventions

Non-surgical peridontal treatment

Eligibility Criteria

Age30 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of severe chronic periodontitis
  • Clinical diagnosis of periodontal health

You may not qualify if:

  • Systemic diseases such as diabetes, cardiovascular disease
  • Periodontal treatment within the previous year
  • Drugs such as systemic steroids, non-steroidal anti-inflammatory drugs, immunosuppressants, hormone drugs, contraceptives, anticoagulants, cholesterol regulating drugs, systemic antibiotics, antioxidants within the previous 3 months
  • Pregnant or lactating
  • Consumed alcohol
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Assistant Professor

Study Record Dates

First Submitted

March 7, 2018

First Posted

September 7, 2020

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

August 1, 2017

Last Updated

September 7, 2020

Record last verified: 2020-09