Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.
| Registry | NCT04786327, acronym RCT |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 21 (Actual) |
| Sponsor | Tanta University (Other) |
| Conditions | Periodontal Regeneration |
| Interventions | Minimal invasive flap technique, Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin, minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S (Procedure, combination product) |
| Dates | start 2018-01-01, primary completion 2019-10-01, completion 2019-10-01, first posted 2021-03-08, last updated 2021-06-18 |
| Locations | 1 site in Egypt |
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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
: 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| treated by using Minimally invasive flap only. | Placebo comparator | Procedure: Minimal invasive flap technique | 7 sites treated with Minimally invasive flap only |
| Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin . | Experimental | Procedure: 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 |
| MIST with root conditioning (EDTA) and GEM 21S . | Experimental | Combination Product: 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 |
Sex: All, ages: 30 Years to 55 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Malak Mohamed Shoukheba | Tanta | Egypt |