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

Phase 2

Completed

• Conditions: Periodontal Regeneration
• Interventions: Procedure: Minimal invasive flap technique; Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S; Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin

• Registration Number: NCT04786327
• Lead Sponsor: Tanta University

Brief 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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treated by using Minimally invasive flap only.	Minimal invasive flap technique	7 sites treated with Minimally invasive flap only
MIST with root conditioning (EDTA) and GEM 21S .	minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S	7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S
Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .	Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin	7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft

Primary Outcome Measures

Name	Time	Method
the change bleeding on probing score	9 months	the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period
the change Clinical attachment level	9 months	the change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe
Cone beam radiograph	9 months	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
the change in probing pocket depth	9 months	the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe

Trial Locations

Locations (1)

Malak Mohamed Shoukheba; 🇪🇬 Tanta, Egypt