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

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ClinicalTrials.gov Identifier: NCT03128502
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Noha Ayman Ghallab, Cairo University

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.

Condition or disease
Chronic Periodontitis Aggressive Periodontitis

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Assessment of Pentraxin-3 Levels in Gingival Crevicular Fluid and Saliva in Periodontal Health and Disease
Actual Study Start Date : December 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : April 2017

Group/Cohort
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).



Primary Outcome Measures :
  1. GCF and salivary pentraxin-3 levels [ Time Frame: baseline ]
    levels of pentraxin-3 in GCF and saliva


Secondary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
salivary and GCF samples


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128502


Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Engy Ahmed, M.D. Associate Professor of Oral Medicine & Periodontology, faculty of Oral and Dental Medicine, Cairo University
Principal Investigator: Yasmine Mansour, B.D.Sc master candidate at faculty of dentistry cairo university
Study Chair: Olfat Shaker Professor of Medical Biochemistry, Faculty of Medicine, Cairo University

Publications of Results:
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Responsible Party: Noha Ayman Ghallab, Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University., Cairo University
ClinicalTrials.gov Identifier: NCT03128502     History of Changes
Other Study ID Numbers: PTX-3_AgP_CP
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noha Ayman Ghallab, Cairo University:
saliva
GCF
pentraxin-3
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases