Comparative study of Iranian xenograft with similar foreign sample for horizontal augmentation in edentulous ridge

Determining the effect of Iranian xenograft with a similar foreign sample for horizontal ridge augmentation in edentulous ridge

The clinical trial includes a control group (equivalence type), with parallel groups, two randomized blind strains, phase 3 of 20 patients, randomizer.com will be used for randomization.

Department of Periodontology, Mashhad Dental School. Simple randomization is performed using statistical software. Concealment is achieved using sealed envelopes. This is a double-blind study. Patients, radiology assessors, and the statistician are blinded to group allocation. The surgeon is not blinded but commits to maintaining confidentiality. Numerical coding is used to maintain blinding. Decoding will be performed by the principal investigator after statistical analysis.

Inclusion criteria: People over 18 years of age and have at least one edentulous area with a horizontal ridge width of less than 5 mm, and the exclusion criteria: pregnancy, uncontrolled systemic disease, and the use of drugs that interfere with bone healing.

Intervention group: Edentulous people with severe horizontal collapse with ridge type B-W and C-W, Misch&Judy classification, therapeutic intervention using Iranian Xenogrip Control group: Edentulous people with severe horizontal collapse with ridge type C-W and BW Misch&Judy classification using foreign xenograft

Bone density, initial stability of implants, horizontal augmentation

Randomization method: Simple randomization Randomization unit: Individual Randomization tool: Statistical software Method of creating random sequence: Using statistical software, patients are randomly divided into two groups of 10 each. Allocation concealment: Sealed envelopes are used. In this study, randomization is performed using statistical software, which ensures accuracy and lack of bias in allocating individuals to groups. After determining each patient's group by the software, this information is placed in sealed envelopes. This concealment method ensures that until the intervention begins, none of the individuals involved in the study (including researchers and patients) are aware of the group allocations, which helps reduce bias in the study. Allocation Concealment: In this study, allocation concealment is done using sealed envelopes. This method works as follows: After randomization by the software, the allocation result for each patient (intervention or control group) is written on a paper. Each paper is placed in a separate envelope. The envelopes are completely sealed and tamper-proof. Each envelope is labeled with the patient's identification number (without mentioning the name). The envelopes are stored in a secure location in numerical order. When each patient enters the study, the envelope corresponding to that patient is opened by someone not involved in the treatment process. The information inside the envelope is only disclosed to the surgeon responsible for performing the intervention.

In this study, the allocator does not know about the content inside the envelopes. They have been delivered to the patients, in which the consent form for participating in the study and the explanation of the study have been provided. Also, the envelopes contain a 4-digit code for the patient. The last code indicates the patient group that only the therapist knows about. After the treatment, the code is written on the patient's file and the analyst will not know about the codes.