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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128502
• Other study ID #: PTX-3_AgP_CP
• Status: Completed
• Phase: N/A
• First received: April 21, 2017
• Last updated: June 14, 2017
• Start date: December 2015
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggressive Periodontitis
• Chronic Periodontitis
• Periodontitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

Gümüs P, Nizam N, Nalbantsoy A, Özçaka Ö, Buduneli N. Saliva and serum levels of pentraxin-3 and interleukin-1ß in generalized aggressive or chronic periodontitis. J Periodontol. 2014 Mar;85(3):e40-6. doi: 10.1902/jop.2013.130281. Epub 2013 Aug 16. — View 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.2013.12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GCF and salivary pentraxin-3 levels	levels of pentraxin-3 in GCF and saliva	baseline
Secondary	plaque index	Oral hygiene status of the patients were recorded using the plaque index of Silness & L?e (1964)	baseline
Secondary	gingival index	Performed using the gingival index of L?e (1967)	baseline
Secondary	probing pocket depth	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.	baseline
Secondary	clinical attachment level	Clinical attachment levels were measured as the distance from the CEJ to the base of the pocket using William's graduated periodontal probe.	baseline