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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treated by using Minimally invasive flap only. | Placebo Comparator | 7 sites treated with Minimally invasive flap only |
|
| Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin . | Experimental | 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 | 7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal invasive flap technique | Procedure | contained defect treated with Minimally invasive flap |
|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| malak m shoukheba, phd | tanta university faculty of dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malak Mohamed Shoukheba | Tanta | 020 | Egypt |
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| Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin | Procedure | contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft |
|
|
| minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S | Combination Product | contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect |
|
|
| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004492 | Edetic Acid |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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