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Completed

NCT Number: NCT03128502

Estimation of Pentrexin-3 Levels in GCF and Saliva of Patients With Periodontal Disease

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.

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Key information

About this study

The study population consisted of 4 groups of forty patients selected as follows:

Group 1 - Healthy Controls:

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.

Group 2 - Plaque induced gingivitis patients:

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.

Group 3 - Chronic periodontitis group:

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.

Group 4 - Aggressive periodontitis group:

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).

GCF and saliva samples were collected for all patients. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. GCF and salivary pentraxin-3 levels

    Time frame: baseline

    levels of pentraxin-3 in GCF and saliva

Secondary outcomes

  1. plaque index

    Time frame: baseline

    Oral hygiene status of the patients were recorded using the plaque index of Silness & Lӧe (1964)

  2. gingival index

    Time frame: baseline

    Performed using the gingival index of Lӧe (1967)

  3. probing pocket depth

    Time frame: baseline

    The depths of the periodontal pockets were measured as the distance from the gingival margin to the base of the pocket using periodontal probe with William's graduation.

  4. clinical attachment level

    Time frame: baseline

    Clinical attachment levels were measured as the distance from the CEJ to the base of the pocket using William's graduated periodontal probe.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Assessment of Pentraxin-3 Levels in Gingival Crevicular Fluid and Saliva in Periodontal Health and Disease

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2017
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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