Comparison of the effects of two incision designs; Double flap and Periosteal releasing, on soft tissue changes following guided bone regeneration, in patients with horizontal ridge defect on posterior mandible

Determining and comparing the effects of Double flap incision(DFI) and Periosteal releasing incision(PRI) on soft tissue changes following guided bone regeneration

Clinical trial with control group, with parallel groups, double-blinded, randomized, on 24 patients. To randomize the samples, the random numbers generation option of the kitset.ir site was used.

The study population includes 24 patients referred to the periodontology department of Babol University of Medical Sciences, who have inclusion and exclusion criteria and will be randomly divided into two groups and will go under GBR surgery. The surgical method adopted in group 1 is DFI. In group 2, the gold standard method, PRI, will be used for surgery. Patients are followed up on the third day and 1, 2, 4, 12 and 24 weeks after surgery, and the desired indexes are collected by a blind examiner in prepared data sheets. Due to the fact that the patient and the examiner do not know the surgical technique, the study will be double-blinded.

Patients over 21 years of age with severe horizontal alveolar bone deformity (Seibert Class I) and in need of GBR treatment in the posterior mandibular region without a history of smoking and systemic disease or unexplained allergies are included in the study.

A GBR will be used before implant placement in both groups. The surgical method adopted in group 1 to reduce tension for flap advancement includes the DFI technique. In group 2, the gold standard method, PRI, will be used for surgery.

Persistent discomfort, pain, swelling, bleeding, the amount of recovery of patients at the surgical site, flap advancement, membrane exposure, infection, paraesthesia

To randomize the samples, the option of generating random numbers on the kitset.ir site was used. For this purpose, random numbers from 1 to 24 was generated as follows, the first half of which case number will be operated by Double flap incision (DFI) method and the second half by Periosteal releasing incision (PRI) method. In the checklist of each patient, only one number is written and the surgical technique used is not specified, so neither the patient nor the examiner knows about the surgical technique used.

In this study, the participant (patient) and the examiner who performs the examination in the follow-up appointments and records the results in the data sheet, do not know which group the patient is in and which surgical technique was used for the patient, because the type of technique will not be recorded in the patient's data sheet, and patients will only be identified by a number and from the appearance of the surgical site, the type of technique cannot be recognized. so the study is double-blinded. The only person who knows the surgical technique is the surgeon, who is not involved in recording the results.

All data is potentially shareable after de-identifying individuals

The access period starts 6 months after the results are published

The data will be available to researchers working in academic and scientific institutions or people working in industry

It is possible to use data or documents for further studies or to choose a more appropriate treatment method for patients

To receive documents or data, contact Dr. Niloofar Jenabian at the following email address. njenabian@hotmail.com

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