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

This study is designed as a randomized, double-blind clinical trial. Forty-eight eligible patients, who meet the inclusion criteria, will be selected and randomly allocated into two groups. Stratified randomization will be employed, utilizing the web-based calculator available at http://www.graphpad.com/quickcalcs/index.cfm.

This study will assess patients at the Mashhad School of Dentistry Implant Department, randomized into two groups: one receiving implant placement at 25–30 N·cm torque, and the other at 55–60 N·cm torque, utilizing a subcrestal technique. Sample size is determined based on comparable studies. Post-implantation, a baseline parallel periapical radiograph will be taken, followed by a second at 4 months to quantify crestal bone loss. Measurements will be double-assessed by two Oral and Maxillofacial Radiologists for reliability.The trial will employ a double-blinded design (patients and the assessors), with all implantations performed by a single operator using the Neodent system. Data will be analyzed via SPSS.23 with a statistical significance threshold of α=0.05.

Inclusion criteria: 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. Exclusion Criteria: Substance abuse and addiction. Use of medications known to interfere with bone osseointegration. Presence of systemic diseases. Presence of periodontal disease.

In the control group, the implant will be placed with a torque of 25 to 30 Newton Centimeters. In the other group, the implant will be placed with a torque of 55 to 60 Newton Centimeters.

Crestal bone loss (millimeter)

Stratified randomization (Stratified randomization) is performed using the website http://www.graphpad.com/quickcalcs/index.cfm. Central randomization (Central randomization) is performed.

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.

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.

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.

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.

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.

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.

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.

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.