Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-09 @ 2:33 AM
Study NCT ID:
NCT03128502
Status:
COMPLETED
Last Update Posted:
2017-06-15
First Post:
2017-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Pentrexin-3 Levels in GCF and Saliva of Patients With Periodontal Disease
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Assessment of Pentraxin-3 Levels in Gingival Crevicular Fluid and Saliva in Periodontal Health and Disease
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: