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Tissue Plasminogen Activator & Plasminogen Activator Inhibitor Type-1 In Gingival Tissues Of Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT03803176
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Gihane Gharib Madkour, Cairo University

Brief Summary:
Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by quantitative reverse transcription polymerase chain reaction in the gingival tissues of chronic periodontitis in an attempt to investigate whether the expression of these proteins could be involved in the disease pathogenesis or not, and to assess as well if their expression will be affected by the applied surgical periodontal treatment.

Condition or disease Intervention/treatment
Chronic Periodontitis Procedure: Open Flap Debridement

Detailed Description:
30 subjects were enrolled in this study and divided into: Group I (Control Group): 10 periodontally healthy volunteers, Group II (Chronic Periodontitis Group): 20 patients suffering severe CP and Group III (Treated Group): 20 patients who were scheduled for OFD. Gingival samples were collected from all subjects at baseline and at 3 months after OFD from the CP patients. Then, Hematoxylin and eosin (H&E) stained slides were examined and gene expression levels of t-PA and PAI-1 were measured in the gingiva through quantitative reverse transcription polymerase chain reaction (RT-PCR).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Effect Of Periodontal Surgery On Tissue Plasminogen Activator And Plasminogen Activator Inhibitor Type-1 Gene Expression In Gingival Tissues Of Chronic Periodontitis Patients
Actual Study Start Date : February 12, 2018
Actual Primary Completion Date : June 11, 2018
Actual Study Completion Date : August 14, 2018

Group/Cohort Intervention/treatment
Periodontally healthy subjects
Healthy subjects who attended the restorative dental clinic and have clinically healthy gingiva with zero plaque index (PI), gingival index (GI), and CAL (≤3 mm PD). Oral hygeine instructions will be given to these patients.
Chronic Periodontitis
Patients with severe Chronic Periodontitis having a pocket depth (PD) of ≥5 mm and a clinical attachment level (CAL) ≥5 mm. Open flap debridement (surgical periodontal therapy) will be carried out for these patients after scaling & root planing.
Procedure: Open Flap Debridement
Full thickness flaps are elevated to fully expose the periodontaldefects. Defects are then fully debrided and the roots are carefully planned. Flaps are repositioned and sutured to obtain primary closure of the interdental space. This will be done for chronic periodontitis patients




Primary Outcome Measures :
  1. Clinical attachment level [ Time Frame: 4 weeks ]
    CAL



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study population includes 30 subjects recruited from the outpatient clinic of Oral Medicine & Periodontology department, Faculty of Dentistry, Cairo University. Ages range from 30-50 years old.
Criteria

Inclusion Criteria:

  • Patients with severe chronic periodontitis
  • Pocket depth (PD) of ≥5 mm
  • Clinical attachment level (CAL) ≥5 mm

Exclusion Criteria:

  • Pregnant women
  • Subjects taking any type of medication and/or antibiotic therapy during the 3 months before the study
  • Subjects who received periodontal treatment within the past 6 months
  • Smokers

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): NCT03803176


Locations
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Egypt
Cairo University
Cairo, Egypt, 12411
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Gihane G Madkour, Ass Prof Cairo University

Additional Information:

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Responsible Party: Gihane Gharib Madkour, Associate Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03803176     History of Changes
Other Study ID Numbers: 12081976
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Plasminogen
Tissue Plasminogen Activator
Plasminogen Inactivators
Plasminogen Activator Inhibitor 1
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors