Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect

Periodontal Regeneration Clinical Trial

— RCT  

Official title:

Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786327
• Other study ID #: 4
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: June 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density

Description:

: Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• Presence of at least one tooth with PPD and CAL loss of = 5 mm associated with an intra-bony defect of = 2 mm according to Cortellini and Tonetti, 2007

Exclusion Criteria:

• Patients with uncontrolled or poorly controlled diabetes, life-threatening conditions, or requiring antibiotic prophylaxis were excluded.

• Smokers

• Pregnant patients.

• Patients with aggressive periodontitis.

• Patients with multiple interconnected vertical defect walls.

Related Conditions & MeSH terms

• Periodontal Regeneration

Intervention

Procedure:
• Minimal invasive flap technique
contained defect treated with Minimally invasive flap
• Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin
contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft

Combination Product:
• minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S
contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect

Locations

Country	Name	City	State
Egypt	Malak Mohamed Shoukheba	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in probing pocket depth	the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe	9 months
Primary	the change bleeding on probing score	the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period	9 months
Primary	the change Clinical attachment level	the change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe	9 months
Primary	Cone beam radiograph	Cone beam radiograph for measuring the change in area of the defect, depth of the depth and bone density at baseline, 3, 6 and 9 month post operative treatment using OnDemand software of cone beam	9 months