Clinical trial NCT03128502: Estimation of Pentrexin-3 Levels in GCF and Saliva of Patients With Periodontal Disease
Official title: Assessment of Pentraxin-3 Levels in Gingival Crevicular Fluid and Saliva in Periodontal Health and Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Periodontitis
Aggressive Periodontitis
Keywords: saliva
GCF
pentraxin-3
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: GCF and salivary pentraxin-3 levels
timeFrame: baseline
Secondary outcomes:
measure: plaque index
timeFrame: baseline
measure: gingival index
timeFrame: baseline
measure: probing pocket depth
timeFrame: baseline
measure: clinical attachment level
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor of Oral Medicine & Periodontology, faculty of Oral and Dental Medicine, Cairo University
name: Engy Ahmed, M.D.
role: STUDY_DIRECTOR
affiliation: master candidate at faculty of dentistry cairo university
name: Yasmine Mansour, B.D.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medical Biochemistry, Faculty of Medicine, Cairo University
name: Olfat Shaker
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.