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

Study Overview
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Brief Summary
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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
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: 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.

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

Conditions
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Periodontal Regeneration

Intervention / Treatment
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* Procedure: Minimal invasive flap technique
* Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin
* Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: treated by using Minimally invasive flap only.<br>7 sites treated with Minimally invasive flap only | Procedure: Minimal invasive flap technique<br>* contained defect treated with Minimally invasive flap<br>* Other names: regenerative surgery;|
| Experimental: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .<br>7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft | Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin<br>* contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft<br>* Other names: regenerative surgery;|
| Experimental: MIST with root conditioning (EDTA) and GEM 21S .<br>7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S | Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S<br>* contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect<br>* Other names: regenerative surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| the change bleeding on probing score | the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period | 9 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic periodontitis, Intra-bony defects, Minimally invasive surgical technique, Platelet rich fibrin,, Growth factor enhanced matrix 21S