]>
IRCT20211122053149N1 IRCT 2021-12-25 Shahid Beheshti University of Medical Sciences Comparison of two xenografts in maxillary sinus augmentation Assessment of histological, clinical and radiographic outcomeُs of maxillary sinus augmentation using two different xenograft materials: split mouth clinical trial 2021-11-06 anticipated 12 Complete https://irct.ir/trial/60179 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study is performed as a split mouth investigation. The left or right side of each participant would be randomized into either the test group or the control group. Simple randomization will be used to select the type of material at each side. After elevation the sinus membrane, the coin toss method will be used to select the type of material in the right maxillary sinus. Bone+ would be used if the coin lands with heads side up, and OCS-B would be used if the coin lands with tails side up. The left sinus would be augmented with the other material. Only the surgeon and the person performing the randomization are aware of the sample allocation. Patients and individuals performing clinical and histological evaluations would be masked to the grouping information, Blinding description: The principal investigator who performs randomization during surgery and the surgeon are aware of the type of material used. Participants are informed about the process of study and using two types of bone grafting materials; however, they are masked to the grouping information. The surgery would be first performed on the right sinus in each participant. After preparation of the sinus cavity, the principal investigator would randomly determine the type of substance to be used in the right sinus; the material will be given to the surgeon in such a way that the participant is prevented to get aware of the name of the material. A unique code would be assigned for each patient and sinus by the principal investigator, and all subsequent evaluations will be based on the codes. Postoperative clinical evaluation will be performed by a person who is unaware of the type of material used. Recording of pre- and post-operative radiographic information is done by an oral radiologist who has no knowledge of the type of material used based on the provided codes. The histologic samples are coded by the principal investigator and sent to the oral pathologist who is unaware of the type of grafting material used. Data analysis is also performed by a statistician based on the provided codes. N/A Maxillary sinus augmentation. Intervention 1: Intervention group: Lateral window maxillary sinus augmentation using Bone+ (Novateb Pars, Iran) at one side of the participant's mouth. Intervention 2: Control group: Lateral window maxillary sinus augmentation using OCS-B (Nibec, Korea) at the other side of the participant's mouth. 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, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2240 3075 a.moscowchi@gmail.com Shahid Beheshti University of Medical Sciences scientific Anahita Moscowchi
Daneshjoo Blvd, Evin, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2240 3075 a.moscowchi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) > 18 years Good general health Inadequate bone for a standard implant (< 5 mm residual alveolar bone height to the maxillary sinus floor) Absence of infection or periapical lesion 18 years no limit Both Smoking O'Leary plaque index > 20% Allergy to the material used in the study Pregnancy/ lactation Uncontrolled periodontal disease Systemic disease or intake of any medication History of sinusitis or any pathologic condition in the sinus K08.2 Atrophy of edentulous alveolar ridge Treatment - Surgery Treatment - Surgery Intervention group: Lateral window maxillary sinus augmentation using Bone+ (Novateb Pars, Iran) at one side of the participant's mouth Control group: Lateral window maxillary sinus augmentation using OCS-B (Nibec, Korea) at the other side of the participant's mouth Sinus augmentation volume. Timepoint: 6 months following maxillary sinus augmentation. Method of measurement: Computed tomography. New bone formation. Timepoint: 6 months after intervention. Method of measurement: Histologic evaluation. Residual material. Timepoint: 6 months after intervention. Method of measurement: Histologic evaluation. Inflammation rate. Timepoint: 6 months after intervention. Method of measurement: Histologic evaluation. Type of inflammation. Timepoint: 6 months after intervention. Method of measurement: Histologic evaluation. Normal connective tissue. Timepoint: 6 months after intervention. Method of measurement: Histologic evaluation. Granulation tissue. Timepoint: 6 months after intervention. Method of measurement: Histologic evaluation. Necrotic tissue. Timepoint: 6 months after intervention. Method of measurement: Histologic evaluation. Giant cell. Timepoint: 6 months after intervention. Method of measurement: Histologic evaluation. Shahid Beheshti University of Medical Sciences Approved 2021-03-03 Ethics committee of Shahid Beheshti University of Medical Sciences Daneshjoo Blv., Evin, Shahid Chamran Hwy Tehran Tehran Iran (Islamic Republic of)