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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803176
• Other study ID #: 12081976
• Status: Completed
• Start date: February 12, 2018
• Est. completion date: August 14, 2018

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 14, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level	CAL	4 weeks