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IRCT20250723066612N1 IRCT 2025-11-06 Deputy of Research, Mashhad University of Medical Sciences Comparison of Crestal Bone Loss in 2 groups with different Seating Torque in the same implant system Comparison of Crestal Bone Loss in 2 groups with different Seating Torque in the same implant system 2025-11-21 anticipated 48 Complete https://irct.ir/trial/85145 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified randomization (Stratified randomization) is performed using the website http://www.graphpad.com/quickcalcs/index.cfm. Central randomization (Central randomization) is performed, Blinding description: Double-blinding is implemented such that both the participants and the researchers—including those involved in selection, data collection, and outcome assessment—are blinded to the group allocation of each individual. In other words, neither the patient nor the research team is aware of the implant’s seating torque value assigned to the participant, ensuring the prevention of any bias or influence on the study outcomes. N/A The amount of crestal bone loss around the implant. Intervention 1: Intervention Group: In the intervention group, implants will be placed with an insertion torque ranging from 55 to 60 Ncm. All patients in this group will receive Neodent implants, which will be positioned using a subcrestal, two-stage surgical protocol. Immediately following the surgery, a baseline radiograph will be obtained utilizing the paralleling technique. The second radiograph will be captured four months post-surgery, coinciding with the second-stage procedure for the connection of the healing abutment, and will be taken using the identical paralleling technique. Intervention 2: Intervention Group: In the intervention group, implants will be placed with an insertion torque ranging from 25 to 30 Ncm. All patients in this group will receive Neodent implants, which will be positioned using a subcrestal, two-stage surgical protocol. Immediately following the surgery, a baseline radiograph will be obtained utilizing the paralleling technique. The second radiograph will be captured four months post-surgery, coinciding with the second-stage procedure for the connection of the healing abutment, and will be taken using the identical paralleling technique. Yes - There is a plan to make this available What will be shared: IPD: Raw data after cleaning included study variables such as demographic information, type of intervention, and outcomes for each individual patient Study protocol: Complete text of study protocol including objectives, study design, randomization and blinding methods, inclusion/exclusion criteria, definitions, and measurement tools. Statistical Analysis Plan: Detailed description of statistical methods, software used, models, and assumptions for tests. Informed Consent Form: Fully signed informed consent forms by participants or template consent form. Clinical Study Report: Comprehensive report including results, discussion, conclusions, patient data summary, and statistical analyses. When: Participant Data File (IPD): From 6 months after the publication of the main study results for at least 5 years. Study Protocol: Available simultaneously with main study publications and archived permanently. Statistical Analysis Plan: Available after publication of primary results, for at least 5 years. Informed Consent Form: Maintained permanently after data collection is completed and publication is permitted. Clinical Study Report: Available after article publication and retained for at least 5 years. To whom: Participant Data File (IPD): Official research center members, researchers with approved related research proposals, and other researchers upon ethical committee and research team approval. Study Protocol: Open access for all researchers and scientific audiences without restrictions. Statistical Analysis Plan: Researchers involved in further analyses or meta-analyses with approved requests. Informed Consent Form: Only study team members and ethical committees. Clinical Study Report: Relevant researchers, regulatory bodies, scientific users for legitimate purposes. Conditions: Participant Data File (IPD): Strictly for research purposes such as secondary analyses or meta-analyses with protection of participant confidentiality and anonymity. Study Protocol: For study review, educational use, and as a reference for similar studies. Statistical Analysis Plan: For reviewing analytical approaches and use in similar research. Informed Consent Form: Verification of ethical compliance in the study. Clinical Study Report: Reviewing results, use in systematic reviews, research projects. Where to obtain: Participant Data File (IPD): Written request to the responsible for the research or the Vice President for Research at Mashhad University of Medical Sciences at the email address RAMResearch@mums.ac.ir Study Protocol: Download via official research center website or by email request. Statistical Analysis Plan: Written request to data analysis lead at the research center. Informed Consent Form: Internal request with ethical committee review if needed. Clinical Study Report: Written request reviewed and approved by research group. How to obtain: Participant Data File (IPD): Initial evaluation by research team, ethics committee approval, signing a data use agreement, and delivery after confidentiality agreements are in place. Study Protocol: Automatic/manual sending upon email request without special authorization. Statistical Analysis Plan: Review of the request based on purpose, approval, and confidentiality agreement before delivery Informed Consent Form: Formal permission required; not available to external parties to ensure confidentiality. Clinical Study Report: Request assessment and permission under confidentiality agreements. Comments: Participant Data File (IPD): Commercial use is prohibited unless explicitly approved in agreements. Study Protocol: Provided in PDF format Statistical Analysis Plan: May include explanatory sessions if needed. Informed Consent Form: Personal identifiers are removed or coded for privacy. Clinical Study Report: Delivered electronically in PDF or suitable formats.
public Nafiseh Nikzat
No.33,jahed 1
Mashhad Iran (Islamic Republic of) 9184313827 +98 912 963 0764 nikzatnafiseh@gmail.com Mashhad University of Medical Sciences scientific Nafiseh Nikzat
No.33,jahed 1
Mashhad Iran (Islamic Republic of) 9184313827 +98 912 963 0764 nikzatnafiseh@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients referred to the Implant Department of the Faculty of Dentistry, Mashhad Patients who have sufficient bone volume for implant placement Consent to participate in the study 20 years 50 years Both Consumption of narcotic drugs and addiction Use of drugs affecting bone osteointegration Having systemic diseases Having periodontal disease Treatment - Surgery Treatment - Surgery Intervention Group: In the intervention group, implants will be placed with an insertion torque ranging from 55 to 60 Ncm. All patients in this group will receive Neodent implants, which will be positioned using a subcrestal, two-stage surgical protocol. Immediately following the surgery, a baseline radiograph will be obtained utilizing the paralleling technique. The second radiograph will be captured four months post-surgery, coinciding with the second-stage procedure for the connection of the healing abutment, and will be taken using the identical paralleling technique. Intervention Group: In the intervention group, implants will be placed with an insertion torque ranging from 25 to 30 Ncm. All patients in this group will receive Neodent implants, which will be positioned using a subcrestal, two-stage surgical protocol. Immediately following the surgery, a baseline radiograph will be obtained utilizing the paralleling technique. The second radiograph will be captured four months post-surgery, coinciding with the second-stage procedure for the connection of the healing abutment, and will be taken using the identical paralleling technique. The amount of crestal bone loss. Timepoint: The level of the crestal bone will be measured immediately following implant placement and subsequently at 4 months post-operation. Method of measurement: At the specified time points, a parallel periapical radiograph will be obtained, and subsequently, the crestal bone level will be compared. Deputy of Research, Mashhad University of Medical Sciences Approved 2024-10-12 Research Ethics Committee, School of Dentistry, Mashhad University of Medical Sciences Mashhad School of Dentistry, Opposite Mellat Park, Vakil Abad Blvd. Beginning, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)