Assessment of Nanocrystalline Hydroxyapatite Versus Autogenous Bone Grafts : A Comparative Clinical Study in Alveolar Cleft Grafting
NCT ID: NCT04693559
Last Updated: 2021-01-05
Study Results
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Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-01-31
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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autogenous iliac bone graft (group A)
autogenous iliac bone graft will be used to fill the alveolar defect
secondary alveolar bone graft
Under general anaesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will made on both the sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will dissected. Next, the bone particles will implanted into the bone defect. The cleft site will closed without tension by advancement of the gingival flaps
harvesting of the autogenous bone graft
osteotome and then cut into small bone granules. The bone granules will then carefully placed into a syringe and pressed to its densest state by pushing the plunger
Nano crystalline Hydroxyapatite (group B)
Nano crystalline Hydroxyapatite will be used to fill the alveolar defect
secondary alveolar bone graft
Under general anaesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will made on both the sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will dissected. Next, the bone particles will implanted into the bone defect. The cleft site will closed without tension by advancement of the gingival flaps
Nanocrystalline Hydroxyapatite
Nanocrystalline Hydroxyapatite will be used to fill the alveolar defect
Interventions
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secondary alveolar bone graft
Under general anaesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will made on both the sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will dissected. Next, the bone particles will implanted into the bone defect. The cleft site will closed without tension by advancement of the gingival flaps
harvesting of the autogenous bone graft
osteotome and then cut into small bone granules. The bone granules will then carefully placed into a syringe and pressed to its densest state by pushing the plunger
Nanocrystalline Hydroxyapatite
Nanocrystalline Hydroxyapatite will be used to fill the alveolar defect
Eligibility Criteria
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Inclusion Criteria
* Non-syndromic CLA or CLP
* More than 6 months of follow-up
Exclusion Criteria
* History of active infection or underlying disease such as hematologic disorders , neoplasm, and immune deficiency
* Patients who had received primary or tertiary ABG
7 Years
12 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Abdullah Hashim Ahmed
MBBS
Central Contacts
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References
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Boyne PJ, Sands NR. Secondary bone grafting of residual alveolar and palatal clefts. J Oral Surg. 1972 Feb;30(2):87-92. No abstract available.
Kyung H, Kang N. Management of Alveolar Cleft. Arch Craniofac Surg. 2015 Aug;16(2):49-52. doi: 10.7181/acfs.2015.16.2.49. Epub 2015 Aug 11.
Cypher TJ, Grossman JP. Biological principles of bone graft healing. J Foot Ankle Surg. 1996 Sep-Oct;35(5):413-7. doi: 10.1016/s1067-2516(96)80061-5.
Feinberg SE, Weisbrode SE, Heintschel G. Radiographic and histological analysis of tooth eruption through calcium phosphate ceramics in the cat. Arch Oral Biol. 1989;34(12):975-84. doi: 10.1016/0003-9969(89)90055-1.
Fernyhough JC, Schimandle JJ, Weigel MC, Edwards CC, Levine AM. Chronic donor site pain complicating bone graft harvesting from the posterior iliac crest for spinal fusion. Spine (Phila Pa 1976). 1992 Dec;17(12):1474-80. doi: 10.1097/00007632-199212000-00006.
Porter AE, Patel N, Skepper JN, Best SM, Bonfield W. Effect of sintered silicate-substituted hydroxyapatite on remodelling processes at the bone-implant interface. Biomaterials. 2004 Jul;25(16):3303-14. doi: 10.1016/j.biomaterials.2003.10.006.
Mankin HJ, Gebhardt MC, Jennings LC, Springfield DS, Tomford WW. Long-term results of allograft replacement in the management of bone tumors. Clin Orthop Relat Res. 1996 Mar;(324):86-97. doi: 10.1097/00003086-199603000-00011.
Other Identifiers
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AssiutU011270
Identifier Type: -
Identifier Source: org_study_id
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