NCT02159781

Brief Summary

The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology, diagnosed with generalized moderate - severe chronic periodontitis. treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions and motivation. Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment. Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment has an affect on saliva components.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

May 28, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

May 28, 2014

Last Update Submit

June 9, 2014

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Whole saliva & translocator protein (TSPO)

    Change in whole saliva \& translocator protein (TSPO) post periodontal treatment

    Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning)

Secondary Outcomes (1)

  • Periodontal measurements (periodontal pocket depth, bleeding on probing & clinical attachment level)

    Intake 8 - 12 weeks post periodontal treatment (scaling & root planning)

Study Arms (1)

periodontal treatmnent

EXPERIMENTAL
Procedure: periodontal treatment - scaling and root planning

Interventions

periodontal treatment - scaling and root planningPROCEDURE
periodontal treatmnent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy patients
  • moderate - sever chronic periodontitis

You may not qualify if:

  • systemic disease
  • pregnancy
  • subjects under the age of 18

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

Central Study Contacts

Eran Front, DMD

CONTACT

+97246652254efront@poria.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Unit of Periodontology - Department of Oral and Maxillofacial surgery

Study Record Dates

First Submitted

May 28, 2014

First Posted

June 10, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

June 10, 2014

Record last verified: 2014-06