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IRCT20211122053149N2 IRCT 2023-09-18 Shahid Beheshti University of Medical Sciences Efficacy of pure xenografts in bone augmentation Efficacy of xenograft materials in maxillary edentulous ridge augmentation: a clinical study 2023-09-06 anticipated 15 Complete https://irct.ir/trial/72304 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Horizontal defect in maxillary ridge. Local anesthesia is administered in the maxilla by injection of 4% articaine plus 1:100,000 epinephrine. A mid-crestal incision is made from the most anterior tooth to 5 mm beyond the augmentation area using a 15c surgical scalpel. An oblique releasing incision is made at the mesial end of the first incision and extended beyond the mucogingival line. A full-thickness flap is reflected using a periosteal elevator. In case of requiring maxillary sinus floor augmentation, the lateral window is outlined with a 5 mm distance from the floor and anterior wall of the sinus by piezosurgery. Intentional perforation of cortical bone of the edentulous ridge is performed at 5 mm intervals using a round diamond bur. A barrier membrane of natural collagen (Bio-Gide, Geistlich Biomaterials, Switzerland) is prepared to correspond to the dimensions of the augmentation site and fixed in the most apical part of the vestibular region by using fixation tacks. Bovine xenograft material (Bio-Oss, Geistlich Biomaterials, Switzerland) is hydrated with sterile saline and applied in the sinus cavity and over the lateral wall of the edentulous ridge. The barrier membrane is extended over the crest to cover the palatal wall of the ridge and fixed in place using additional tacks. The flap is released with periosteal-releasing incisions at the flap base, and also by releasing muscle attachments at the vestibular side. The flap margins are coronally displaced with tension-free mattress sutures (poly-glycolic acid). Additional simple sutures are applied to ensure complete sealing of the incision site. Oblique incisions are approximated by using simple single sutures. The sutures are removed after 2 weeks, and the patients are instructed to refrain from using a removable partial denture during the healing period. A minimum of 6 months after surgery, CBCT of the augmented area is requested and the treatment results are assessed.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Anahita Moscowchi
Daneshjoo Blvd, Evin, Chamran Hwy
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 2314 a.moscowchi@gmail.com Shahid Beheshti University of Medical Sciences scientific Anahita Moscowchi
Daneshjoo Blvd, Evin, Chamran Hwy
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 2314 a.moscowchi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Partial/complete edentulism of the maxillary ridge with or without the need for maxillary sinus floor augmentation Patients requiring implant-supported fixed dentures Availability of follow-up data of patients for a minimum of 6 months after edentulous ridge augmentation. 18 years no limit Both Smoking Alcohol consumption Substance abuse Uncontrolled metabolic disorders Untreated periodontal disease History of radiotherapy or intake of immunosuppressants History of intake of anti-resorptive medications Treatment - Surgery Local anesthesia is administered in the maxilla by injection of 4% articaine plus 1:100,000 epinephrine. A mid-crestal incision is made from the most anterior tooth to 5 mm beyond the augmentation area using a 15c surgical scalpel. An oblique releasing incision is made at the mesial end of the first incision and extended beyond the mucogingival line. A full-thickness flap is reflected using a periosteal elevator. In case of requiring maxillary sinus floor augmentation, the lateral window is outlined with a 5 mm distance from the floor and anterior wall of the sinus by piezosurgery. Intentional perforation of cortical bone of the edentulous ridge is performed at 5 mm intervals using a round diamond bur. A barrier membrane of natural collagen (Bio-Gide, Geistlich Biomaterials, Switzerland) is prepared to correspond to the dimensions of the augmentation site and fixed in the most apical part of the vestibular region by using fixation tacks. Bovine xenograft material (Bio-Oss, Geistlich Biomaterials, Switzerland) is hydrated with sterile saline and applied in the sinus cavity and over the lateral wall of the edentulous ridge. The barrier membrane is extended over the crest to cover the palatal wall of the ridge and fixed in place using additional tacks. The flap is released with periosteal-releasing incisions at the flap base, and also by releasing muscle attachments at the vestibular side. The flap margins are coronally displaced with tension-free mattress sutures (poly-glycolic acid). Additional simple sutures are applied to ensure complete sealing of the incision site. Oblique incisions are approximated by using simple single sutures. The sutures are removed after 2 weeks, and the patients are instructed to refrain from using a removable partial denture during the healing period. A minimum of 6 months after surgery, CBCT of the augmented area is requested and the treatment results are assessed. Buccolingual width of the ridge at the level of 2 mm apical to the alveolar crest. Timepoint: Measurement of ridge width at the beginning of treatment and at least 6 months after surgery. Method of measurement: Cone beam computed tomography. Ridge height based on a fixed point on the nasal floor or sinus floor. Timepoint: At the beginning of treatment and at least 6 months after surgery. Method of measurement: Cone beam computed tomography. Height increase in the sinus area in cases where sinus augmentation would also been performed. Timepoint: At the beginning of treatment and at least 6 months after surgery. Method of measurement: Cone beam computed tomography. Shahid Beheshti University of Medical Sciences Approved 2023-08-01 Ethics committee of Shahid Beheshti University of Medical Sciences Daneshjoo Blv., Evin, Shahid Chamran Hwy Tehran Tehran Iran (Islamic Republic of)