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IRCT20211119053106N1 IRCT 2021-12-06 Islamic Azad University Buccal bone Dimensional changes in immediate implant placement Buccal bone Dimensional changes in immediate implant placement with and without bone graft with immediate provisionalization: A Randomized Clinical Trial 2022-01-21 anticipated 30 Complete https://irct.ir/trial/60225 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated (1:1) to group 1 (with bone graft) and group 2 (without bone graft). The randomization sequence will be generated by an independent investigator using computer software (www.randomization.com). Balanced Blocked randomization will be used, with a block size of 4. The surgeon will open sequentially numbered, sealed envelopes only after the implants will be inserted on the day of the surgeries. Although the surgeon will be aware of the allocated arm, the radiographic outcome assessor will be kept blinded to the allocation, Blinding description: Participants (patients) are completely blind to whether they are in the control or intervention group. N/A Immediate implant. Intervention 1: Intervention group: Immediate implant placement + placement of SigmaGraft-InterOss bone graft material made in the USA in the distance between implant and buccal bone. Intervention 2: Control group: Immediate placement of implant + without bone graft. Yes - There is a plan to make this available What will be shared: All potential data can be shared after the participants are unidentifiable When: Access period starts from 2024 To whom: Only for researchers working in academic and scientific institutions Conditions: The data can be used for scientific researches Where to obtain: Salar Chaychi Salmasi 0098 9143439375 Salar.chaychis@gmail.com How to obtain: After submitting the request, the request will be reviewed and answered as soon as possible. Comments:
public Salar Chaychi Salmasi
No. 115, Kalhor St, Zare St, Azadi St
Tehran Iran (Islamic Republic of) 1311765671 +98 21 6642 4869 Salar.chaychis@gmail.com Islamic Azad University scientific Salar Chaychi Salmasi
No. 115, Kalhor Ave, Zare Ave, Azadi Str
Tehran Iran (Islamic Republic of) 1311765671 +98 21 6642 4869 salar.chaychis@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Patients require removal of a maxillary anterior tooth and the possibility of immediate implant placement in the same site presence of buccal bone Gap space greater than 2 mm between implant and buccal bone no limit no limit Both periodontal disease presence of systemic or local diseases that may interfere with bone repair Use of drugs that prevent implant placement or interfere with implant osteointegration Pregnancy addiction to Drug and smoking Presence of acute infection at the implant site Patient undergoing radiotherapy Patients with parafunctional habits such as Bruxism or Clenching Treatment - Surgery Treatment - Surgery Intervention group: Immediate implant placement + placement of SigmaGraft-InterOss bone graft material made in the USA in the distance between implant and buccal bone. Control group: Immediate placement of implant + without bone graft Bone dimensional Changes. Timepoint: At the beginning of the study and 6 months after the intervention (immediate implant placement). Method of measurement: Cone Beam Computed Tomography Pictures. Secondary outcomes: 1) Implant failure: Any implant that is removed after placement due to mobility, progressive marginal bone resorption, infection, or any mechanical complication (e.g., implant fracture). 2) Prosthesis failure: All prosthesis that fail with the implant or can not be placed due to implant failure or will be replaced for any reason. 3) Biological or prosthetic complications. Timepoint: 6 months after intervention (implant placement). Method of measurement: Clinical examination and Cone Beam Computed Tomography images. Islamic Azad University Approved 2021-11-10 Research Ethics Committees of Islamic Azad University - Dental Branch Tehran - Iran No. 9, School of Dentistry, Tehran Azad University of Medical sciences, 9th Neyestan, Pasdaran Ave Tehran Tehran Iran (Islamic Republic of)