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IRCT20260124068649N1 IRCT 2026-01-30 Rasht University of Medical Sciences The Effect of Using Osseodensification Drills on the Stability of Dental Implants The Effect of Using Osseodensification Drills on the Stability of Dental Implants in the Maxilla: A Randomized Split‑Mouth Clinical Trial 2026-02-19 anticipated 12 Complete https://irct.ir/trial/88826 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this split‑mouth randomized clinical trial, treatment type and jaw side are allocated using permuted block randomization with a block size of 4. The random sequence is generated using SAS software (version 9), with A/B indicating treatment type and C/D indicating jaw side. Only the data analyst is aware of the allocation codes. Allocation concealment is ensured using sealed, opaque, numbered envelopes prepared by an independent researcher. After patient enrollment, one envelope is opened to determine the assigned treatment and jaw side. Implant surgery is performed by one researcher, while data collection and outcome assessment are carried out by another researcher blinded to allocation, Blinding description: The intervention will be performed bilaterally in the maxilla for each patient, and both drilling techniques (osseodensification and conventional drilling) will be used in every participant. Participants will be blinded to the allocation of the drilling technique to each side. The surgical procedures will be performed by one investigator, while outcome assessment and data collection will be carried out by a second investigator who is blinded to group allocation. Only the data analyst will have access to the treatment codes. 2-3 Maxillary Partial Edentulism requiring Dental Implants. Intervention 1: Interventions group: In the intervention group, implant site preparation will be performed using the osseodensification technique. For this purpose, the Charisma osseodensification drill kit (manufacturer: Pakistan) will be used.In this technique, the drills are operated in a counter‑clockwise rotation with the aim of compacting and preserving the peri‑implant bone. Unlike conventional drilling, this method is a non‑excavation technique, in which bone is not removed from the osteotomy site.Osteotomy preparation will be carried out according to the manufacturer’s instructions. After completion of the osteotomy, Dio dental implants with dimensions of 8.3 × 10 mm (regular type) will be placed using an implant motor at a speed of 30 rpm and an insertion torque of 30 Ncm. Intervention 2: control group: In the control group, implant site preparation will be performed using the conventional subtractive drilling technique. A standard DIO drilling kit (manufactured in South Korea) will be used according to the manufacturer’s recommended protocol.In this method, the osteotomy is prepared through gradual removal of bone, with sequential use of drills of increasing diameters until the final osteotomy size is achieved.Following site preparation, implants with specifications identical to those used in the intervention group (Dio, 8.3 × 10 mm, regular type) will be placed at a speed of 30 rpm and an insertion torque of 30 Ncm. 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 We are currently evaluating the feasibility and ethical‑legal implications of sharing de‑identified IPD. Key considerations include participant re‑consent, data anonymization techniques, institutional policies, and resource availability. A final decision will be made after consultation with our ethics committee and data‑protection officer.
public Ashkan Salari
Rasht, Saravan road to Foman, Gilan Dental Clinic
Rasht Iran (Islamic Republic of) 4194173774 +98 13 3348 6406 Drashkan_salary@yahoo.com Rasht University of Medical Sciences scientific Ashkan Salari
Rasht, Saravan road to Foman, Gilan Dental Clinic
Rasht Iran (Islamic Republic of) 4194173774 +98 13 3348 6406 Drashkan_salary@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Age 18 years or older Indication for placement of two implants in the premolar regions on both sides of the jaw, in edentulous areas at least 6 months after tooth extraction Bone density: D3–D4 18 years no limit Both Presence of acute or chronic infection or local pathology at the intended implant placement site Patients with parafunctional habits Limitations to implant placement, such as insufficient vertical bone height Use of medications that interfere with bone healing, such as corticosteroids, hormone therapy, or bisphosphonates History of uncontrolled systemic diseases or conditions that interfere with bone healing, including smoking, diabetes, immunosuppression, fibrous dysplasia, bleeding disorders, hyperparathyroidism, pregnancy, and a history of head and neck radiotherapy or chemotherapy within the past 5 years K08.4 Partial loss of teeth Treatment - Devices Treatment - Devices Interventions group: In the intervention group, implant site preparation will be performed using the osseodensification technique. For this purpose, the Charisma osseodensification drill kit (manufacturer: Pakistan) will be used.In this technique, the drills are operated in a counter‑clockwise rotation with the aim of compacting and preserving the peri‑implant bone. Unlike conventional drilling, this method is a non‑excavation technique, in which bone is not removed from the osteotomy site.Osteotomy preparation will be carried out according to the manufacturer’s instructions. After completion of the osteotomy, Dio dental implants with dimensions of 8.3 × 10 mm (regular type) will be placed using an implant motor at a speed of 30 rpm and an insertion torque of 30 Ncm. control group: In the control group, implant site preparation will be performed using the conventional subtractive drilling technique. A standard DIO drilling kit (manufactured in South Korea) will be used according to the manufacturer’s recommended protocol.In this method, the osteotomy is prepared through gradual removal of bone, with sequential use of drills of increasing diameters until the final osteotomy size is achieved.Following site preparation, implants with specifications identical to those used in the intervention group (Dio, 8.3 × 10 mm, regular type) will be placed at a speed of 30 rpm and an insertion torque of 30 Ncm. Implant Stability. Timepoint: Immediately, 2, 8, and 12 weeks after implant placement. Method of measurement: Implant stability will be measured using the AnyCheck device (Neo Biotech, South Korea) in direct contact with the healing abutment. Marginal Bone Loss. Timepoint: Three months after implant placement. Method of measurement: Measurement of the distance between the first thread of the implant and the crestal bone on parallel periapical radiographs, recorded in tenths of a millimeter. Patient-reported Pain & Discomfort. Timepoint: Immediately after the surgery and one week after implant placement. Method of measurement: The level of pain and discomfort experienced by patients will be measured using the Visual Analog Scale (VAS). Initial survival rate. Timepoint: Three months after implant placement. Method of measurement: Evaluating the survival rate of the implants in the follow-up session. Bone density. Timepoint: 12 weeks after implant placement. Method of measurement: The bone density of the area around the implant will be classified using CBCT and the Lekholm & Zarb classification into five categories: D1, D2, D3, D4, and D5. Rasht University of Medical Sciences Approved 2026-01-14 Research Ethics Committees of Guilan university of medical sciences Fouman - Saravan Rd Rasht Guilan Iran (Islamic Republic of)