NCT03128502

Brief Summary

Subjects were selected from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. Ten healthy control subjects presented with clinically healthy periodontium. Ten patients who had plaque induced gingivitis. Ten patients who had generalized chronic periodontitis. Ten patients who had generalised aggressive periodontitis. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

April 21, 2017

Last Update Submit

June 14, 2017

Conditions

Keywords

salivaGCFpentraxin-3

Outcome Measures

Primary Outcomes (1)

  • GCF and salivary pentraxin-3 levels

    levels of pentraxin-3 in GCF and saliva

    baseline

Secondary Outcomes (4)

  • plaque index

    baseline

  • gingival index

    baseline

  • probing pocket depth

    baseline

  • clinical attachment level

    baseline

Study Arms (4)

healthy control

Ten healthy control subjects presented with clinically healthy periodontium. Control subjects had to meet the following criteria for inclusion: probing depth less than 3mm, no clinical attachment loss, no bleeding on probing, with Gingival and Plaque index 0-1.

plaque induced gingivitis

Ten patients who had plaque induced gingivitis characterized by the presence of any of the following clinical signs: redness and edema of the gingival tissue, bleeding upon provocation, changes in contour and consistency, presence of calculus and/or plaque, with no clinical attachment loss nor radiographic evidence of bone loss.

chronic periodontitis

Ten chronic moderate to severe periodontitis patients selected according to the criteria currently adopted by Armitage 1999. Moderate destruction is generally characterized by periodontal probing depths up to 6 mm with clinical attachment loss of up to 4 mm. Advanced destruction is generally characterized by periodontal probing depths greater than 6 mm with attachment loss greater than 4 mm. Radiographic evidence of bone loss is apparent, Increased tooth mobility may be present.

aggressive periodontitis

Ten patients suffering generalized aggressive periodontitis, patients were less than 35 years of age and had generalized interproximal attachment loss affecting at least 3 permanent teeth other than the first molars and incisors with at least one site each with PD and CAL \>5 mm, Attachment loss occurs in pronounced episodic periods of destruction, and there is familial aggregation (subjects were asked if they had at least one other member of the family presenting or with a history of periodontal diseases).

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University suffering from diffrent periodontal diseases.

You may qualify if:

  • patients with plaque induced gingivitis
  • patients with chronic periodontitis
  • patients with aggressive periodontitis

You may not qualify if:

  • Patients with any systemic disease according to Cornell medical index (1968).
  • Patients taking any medications or antibiotics in the last 3 months.
  • Current or former smoker patients.
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Fujita Y, Ito H, Sekino S, Numabe Y. Correlations between pentraxin 3 or cytokine levels in gingival crevicular fluid and clinical parameters of chronic periodontitis. Odontology. 2012 Jul;100(2):215-21. doi: 10.1007/s10266-011-0042-1. Epub 2011 Sep 20.

  • Lakshmanan R, Jayakumar ND, Sankari M, Padmalatha O, Varghese S. Estimation of pentraxin-3 levels in the gingival tissues of chronic and aggressive periodontitis participants: an in vivo study. J Periodontol. 2014 Feb;85(2):290-7. doi: 10.1902/jop.2013.120718. Epub 2013 May 23.

  • Gumus P, Nizam N, Nalbantsoy A, Ozcaka O, Buduneli N. Saliva and serum levels of pentraxin-3 and interleukin-1beta in generalized aggressive or chronic periodontitis. J Periodontol. 2014 Mar;85(3):e40-6. doi: 10.1902/jop.2013.130281. Epub 2013 Aug 16.

Biospecimen

Retention: SAMPLES WITHOUT DNA

salivary and GCF samples

MeSH Terms

Conditions

Chronic PeriodontitisAggressive Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Engy Ahmed, M.D.

    Associate Professor of Oral Medicine & Periodontology, faculty of Oral and Dental Medicine, Cairo University

    STUDY DIRECTOR
  • Yasmine Mansour, B.D.Sc

    master candidate at faculty of dentistry cairo university

    PRINCIPAL INVESTIGATOR
  • Olfat Shaker

    Professor of Medical Biochemistry, Faculty of Medicine, Cairo University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.

Study Record Dates

First Submitted

April 21, 2017

First Posted

April 25, 2017

Study Start

December 1, 2015

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share