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IRCT20200105046011N1 IRCT 2020-02-15 Mashhad University of Medical Sciences Comparison of Periosteal pocket flap technique with autogenous bone block Comparison of Periosteal pocket flap technique with autogenous bone block for horizontal bone augmentation 2019-04-06 anticipated 17 Complete https://irct.ir/trial/44802 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual block randomization with the random number tables Based on the CONSORT criteria, we coded the patients based on their number and assigned a random code to each patient. We put Periosteal pocket flap and autogenic block methods in the envelope and assign a special number to it randomly based on a random number table. Then we assign the envelope to the patient based on the patient code and random number and the procedure is performed by the surgeon. N/A horizontal alveolar ridge resorption. Intervention 1: Intervention group: Using the periosteal pocket flap method, after local anesthesia, a horizontal incision is made on the periosteum to create a small space between the periosteum and the mucosa. This space is then deepened using a periosteal elevator to completely separate the mucosa from the periosteum. Vertical releases are applied only to the mucosa if needed. The mucosal flap is then separated by the periosteal elevator over the mucogingival line, and the periosteum is then elevated from the bone to create a periosteal pocket between the bone and the periosteum. After biomaterial application including particulate allograft ine the size of 500-1000 micrometer (Regen Allograft- Iranian Tissue Product Company- Tehran-Iran), collagen membranes with 0.6-1 mm width (Regen Alloderm- Iranian Tissue Product Company- Tehran-Iran) are inserted over the biomaterial in the envelope. The buccal flap is then sutured to the palatal or lingual flap using the Vicryl 4-0 suture. Intervention 2: Control group: Bone block harvesting is done from the ramus mandibular area, then fixation of the block by titanium screws (JEIL Medical Corporation- Seoul-Korea). Flap tension is eliminated by applying periosteal-releasing at the buccal vestibule. The gaps between the block and the receptor area are filled by particulate allograft with a size of 500-1000 micrometer (Regen Allograft- Iranian Tissue Product Company- Tehran-Iran) and a collagen membrane with a width of 0.6-1 mm (Regen Alloderm-Iranian Tissue Product Company-Tehran-Iran) places over them. The buccal flap is then sutured to the palatal or lingual flap using the Vicryl 4-0 suture. Yes - There is a plan to make this available What will be shared: Information of the age, sex, and width of the alveolar ridge before and after surgery as well as will be shared as well as the enhancement of the alveolar ridge width will be share. When: Start of access period 6 months after publishing the results To whom: Researchers working in academic and scientific institutions Conditions: The data can be used to conduct a similar study. Where to obtain: Leila khodadadifard Address: Qom dentistry school, Qom university of medical science, Qom, Iran Email address: l.khodadadifard@gmail.com How to obtain: Sending an email request for data which containing information about the applicant for employment in academic and scientific institutions. Data file will be sent by an email within one week. Comments:
public Leila Khodadadifard
Qom dentistry school, Qom university of medical science, Saheli street, Qom, Iran
Qom Iran (Islamic Republic of) 3713649373 +98 25 3770 0094 l.khodadadifard@gmail.com Ghoum University of Medical Sciences scientific Leila Khodadadifard
Qom dentistry school, Qom university of medical science, Saheli street, Qom, Iran
Qom Iran (Islamic Republic of) 3713649373 +98 25 3770 0094 l.khodadadifard@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) edentulous area requiring horizontal bone reconstruction 18 years no limit Both previous bone graft in the area cigarette smoking drug abuse Treatment - Surgery Treatment - Surgery Intervention group: Using the periosteal pocket flap method, after local anesthesia, a horizontal incision is made on the periosteum to create a small space between the periosteum and the mucosa. This space is then deepened using a periosteal elevator to completely separate the mucosa from the periosteum. Vertical releases are applied only to the mucosa if needed. The mucosal flap is then separated by the periosteal elevator over the mucogingival line, and the periosteum is then elevated from the bone to create a periosteal pocket between the bone and the periosteum. After biomaterial application including particulate allograft ine the size of 500-1000 micrometer (Regen Allograft- Iranian Tissue Product Company- Tehran-Iran), collagen membranes with 0.6-1 mm width (Regen Alloderm- Iranian Tissue Product Company- Tehran-Iran) are inserted over the biomaterial in the envelope. The buccal flap is then sutured to the palatal or lingual flap using the Vicryl 4-0 suture. Control group: Bone block harvesting is done from the ramus mandibular area, then fixation of the block by titanium screws (JEIL Medical Corporation- Seoul-Korea). Flap tension is eliminated by applying periosteal-releasing at the buccal vestibule. The gaps between the block and the receptor area are filled by particulate allograft with a size of 500-1000 micrometer (Regen Allograft- Iranian Tissue Product Company- Tehran-Iran) and a collagen membrane with a width of 0.6-1 mm (Regen Alloderm-Iranian Tissue Product Company-Tehran-Iran) places over them. The buccal flap is then sutured to the palatal or lingual flap using the Vicryl 4-0 suture. Horizontal alveolar ridge augmentation in milimeter. Timepoint: before intervention, 26 weeks after surgery. Method of measurement: cone beam computed tomography survey. Mashhad University of Medical Sciences Approved 2018-12-19 Ethics committee of Mashhad University of Medical Sciences Qom dental school, Qom university of medical science, Saheli Ave., Qom Mashhad Razavi Khorasan Iran (Islamic Republic of)