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to evaluate and compare efficacy of two different putty forms for both Demineralized Bone Matrix allograft (DBM) and nanocrystalline hydroxyapatite (NCHA) in treatment of intrabony defects with the aid of intramarrow penetration,
A total of twenty patients will be diagnosed with stage III grade B periodontitis according to the Caton classification. They will be selected from the clinic of Department of Periodontology and Oral Medicine, Faculty of Dentistry, Mansoura University
Patients will be classified into two groups:
Clinical assessment:
including the following parameters:
Plaque Index (PI).
Gingival Index (GI).
Clinical Attachment Level (CAL)
Probing Depth (PD) Radiological parameters
Inclusion criteria:
Both genders with 25-55 years of age. Patients with intrabony defects in the Stage III Grade B periodontitis. Individuals with probing depth ≥ 5mm. Individuals with clinical attachment loss ≥ 5mm. Presence of at least one or more intrabony defect ≥ 3 mm on the radiograpgh patients who had not periodontal therapy in the previous 6 months.
Exclusion criteria:
Patient with stage I, II and IV periodontitis. Pregnant or lactating mothers. Patients having any systemic disease. allergies to Local anesthesia and chlorhexidine, antibiotics, and analgesics will be excluded.
Clinical assessment:
including the following parameters: Plaque Index according to Silness P. Loe H 1964. 2. Gingival Index according Loe Silness 1963. 3. Probing pocket depth (PPD) is measured from the free gingival margin to the base of the pocket. 4. Clinical attachment level (CAL) is measured from the cement enamel junction to the base of the pocket.
• In patients All clinical assessments will be recorded at the baseline (immediate before surgery) and after 3 ,6 and 12months post-surgery and radiographic assessments will be recorded at the baseline and after 6 and 12months post-surgery.
This study was conducted following guidelines regulating research work on human subjects of the Faculty of Dentistry, Mansoura University, and the study protocol was reviewed and approved by the Research Ethics Committee of the Faculty of Dentistry, Mansoura University, Egypt. (Number:M0104023OM) All study subjects will sign written informal consent form before enrollment.
Materials:
nanocrystalline hydroxyapatite in putty form (NanoBone® SBX Putty) is a unique and patented advanced bone grafting material. It incorporates nano-crystalline particles of hydroxyapatite (HA) that are similar in size, chemistry, and morphology to HA particles occurring in human bone. It is Synthetic biodegradable bone graft substitute consisting of non-sintered nanocrystalline hydroxyapatite in a porous silica gel matrix embedded in an aqueous gel
Demineralized Bone Matrix allograft (DBM Putty). presurgical phase:
surgical phase:
post-surgical phase:
Statistical Analysis:
All data will be calculated and analyzed by suitable statistical tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nanocrystalline hydroxyapatite in putty form | Active Comparator | • Group I: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of nanocrystalline hydroxyapatite in putty form as grafting material. |
|
| Demineralized Bone Matrix allograft putty as grafting material | Active Comparator | group II in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of Demineralized Bone Matrix allograft putty as grafting material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nanocrystalline hydroxyapatite in putty form | Procedure | decortication will be performed by penetrating the cortical walls of the intrabony defect by using a round carbide bur of 0.2 mm diameter to reach the marrow space.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical (Clinical attachment level CAL) | It was measured since the CEJ to the base of the pocket with UNC-15 periodontal probe | 3,6,12 months |
| Radiographical Analysis of bone defect | Assessment of bone defect area by digital intraoral periapical (IOPA) radiographs. | at baseline, 6, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry , Mansoura University | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
it will be decided during the publication times as it may be provided as supplementary files
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A total of twenty patients will be diagnosed with stage III grade B periodontitis according to the Caton classification. They will be selected from the clinic of Department of Periodontology and Oral Medicine, Faculty of Dentistry, Mansoura University
Patients will be classified into two groups:
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|
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| Demineralized Bone Matrix allograft putty | Procedure | decortication will be performed by penetrating the cortical walls of the intrabony defect by using a round carbide bur of 0.2 mm diameter to reach the marrow space. • Multiple perforations will performed not closer than 1mm from each other and deep enough to obtain bleeding from the spongiosa • The intrabony defects in Group II will be received Demineralized Bone Matrix allograft putty as grafting material, in both groups will be use membrane to cover of the graft materials and finally will be sutured the flap. |
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