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

NCT03803176 | Completed DMC

• 1 other identifier: 12081976
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level

  CAL

  4 weeks

Study Arms (2)

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

Interventions

Open Flap Debridement PROCEDURE

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

Chronic Periodontitis

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12411, Egypt

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gihane G Madkour, Ass Prof

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: February 12, 2018
• Primary Completion: June 11, 2018
• Study Completion: August 14, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

EG (1)