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

NCT ID: NCT03128502

Last Updated: 2017-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Periodontitis Aggressive Periodontitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha Ayman Ghallab

Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Engy Ahmed, M.D.

Role: STUDY_DIRECTOR

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

Yasmine Mansour, B.D.Sc

Role: PRINCIPAL_INVESTIGATOR

master candidate at faculty of dentistry cairo university

Olfat Shaker

Role: STUDY_CHAIR

Professor of Medical Biochemistry, Faculty of Medicine, Cairo University

References

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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.

Reference Type RESULT
PMID: 21932007 (View on PubMed)

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.

Reference Type RESULT
PMID: 23701480 (View on PubMed)

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.

Reference Type RESULT
PMID: 23952075 (View on PubMed)

Other Identifiers

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PTX-3_AgP_CP

Identifier Type: -

Identifier Source: org_study_id

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