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IRCT20250601066010N1 IRCT 2025-06-03 Mashhad University of Medical Sciences Clinical and radiographic assessment of reverse drilling technique on the upper jaw dimension and bone level in sinus lift surgery Clinical and radiographic assessment of reverse drilling technique on bone dimension and crestal bone level in closed sinus lift surgery 2025-06-18 anticipated 30 Complete https://irct.ir/trial/83999 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, blocked randomization will be used to ensure that an equal number of participants are allocated to the intervention and control groups in successive but equal time intervals. In this way, for example, one type of treatment will be assigned to the first block, the other type to the second block, then the first type again to the third block, and so on. The advantage of blocked randomization is that it guarantees balance in the number of participants between groups. The difference in the number of individuals in each group will never exceed half the size of each block. Accordingly, envelopes will be prepared equal to the sample size, and each generated random sequence will be recorded on a separate sheet of paper. These sheets will then be placed inside sealed envelopes in the order of the generated sequence. To preserve the randomization sequence, the envelopes will be numbered on the outside accordingly. At the time of surgery, based on the order of eligible participants entering the study, one of the sealed envelopes will be opened in sequence, and the participant’s group allocation will be determined, Blinding description: In the present study, since two different kits—Straumann and Densah—will be used for reverse drilling, blinding of the surgeon is not feasible. However, the patients and the individual responsible for clinical and radiographic evaluations will be blinded to group allocation. 2-3 Closed sinus lift. Intervention 1: Intervention group: Patients undergoing closed sinus lift using the reverse drilling technique with the Straumann kit. Intervention 2: Control group: Patients undergoing closed sinus lift using the commonly practiced reverse drilling technique with the Densah kit. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to ethical considerations, no decision has been made regarding sharing.
public Ali Forouzanfar
Vakil abad blvd.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 ForouzanfarA@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Forouzanfar
Vakil abad blvd.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 ForouzanfarA@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patient is a candidate for implant placement in the posterior maxilla. The bone height in the posterior maxillary region is 4 to 5 millimeters. Implant placement requires a closed sinus lift. There is sufficient interarch space. The patient is in overall systemic health and does not take any medications. 18 years no limit Both The patient has uncontrolled systemic diseases such as cardiovascular disease, diabetes, or immune disorders. The Schneiderian membrane becomes perforated during surgery. K08.21 Moderate atrophy of the maxilla Treatment - Devices Treatment - Devices Intervention group: Patients undergoing closed sinus lift using the reverse drilling technique with the Straumann kit. Control group: Patients undergoing closed sinus lift using the commonly practiced reverse drilling technique with the Densah kit. The extent of sinus floor augmentation. Timepoint: 3 months post-augmentation. Method of measurement: Assessing the vertical elevation of the sinus floor using radiographic examination. Marginal Bone Level. Timepoint: Three months after augmentation and implant placement. Method of measurement: Measurement of the distance between the first thread of the implant and the crestal bone on periapical radiographs, recorded in tenths of a millimeter. Perforation of the Schneiderian membrane. Timepoint: Immediately after sinus augmentation. Method of measurement: Valsalva maneuver. Initial survival rate. Timepoint: Three months after augmentation and implant placement. Method of measurement: Evaluating the survival rate of the implants in the follow-up session. Evaluating the insertion torque of the implant. Timepoint: During the implant insertion. Method of measurement: Torque meter. Mashhad University of Medical Sciences Approved 2025-04-26 Research Ethics Committees of School of Dentistry - Mashhad University of Medical Sciences Vakil abad blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)