Evaluating the effect of photobiomodulation therapy with 445 nm diode laser on peri-implant soft tissue healing following uncovering: a triple-blind, split-mouth, randomized controlled trial.

determination the effect of photomodulation treatment with 445 nm diode laser on the repair of soft tissue around the implant after the second stage surgery and to determine the patient's satisfaction with the treatment.

This clinical trial is two-arms, with parallel groups, triple-blind, randomized, on 10 patients. For randomization, a randomization list will be prepared by the statistics consultant using the RAND function in Excel software and will be provided to the researcher.

This split-mouth, the triple-blind trial will be performed in a private office by a surgeon in 1401-1400. This study will be blinded in three directions. In this study, the patient, the evaluator (consisting of two periodontists, a maxillofacial surgeon who measures the outcomes of the study based on the EHS index), and the statistical analyst (statistics consultant) will be blinded in the intervention and control process.

Patients who have received dental implants in a two-stage method and bilaterally in one jaw will enter the study by considering the inclusion and exclusion criteria and signing a written informed consent form.

After uncovering process, the surgeon will insert healing abutments (after three months)، suture the incision line with absorbable suture in simple interrupted method, on days zero (immediately after surgery), third, seventh, and fourteenth after surgery, patients will receive 445 nm blue diode laser by a laser operator (one of the researchers) in the buccal and lingual area will be exposed.

Early Wound Healing Score (by scoring the Early Wound Healing Index (EHS) in the data collection form) Patient evaluation of pain and discomfort in the surgical area (by scoring patients using the VAS ruler in the data collection form)

Using a simple randomized method, one side of the mouth is considered as the intervention area and the other side of the mouth is considered as the control. A randomization list will be prepared by the statistics consultant using the RAND function in Excel software and will be provided to the researcher. In the intervention area, the soft tissue around the desired dental implant will be exposed by laser. In the control area, the laser device probe will be used in off mode in the soft tissue area around the desired dental implant.

In this study, the patient, the evaluator (consisting of two periodontists and a maxillofacial surgeon who measures the outcomes of the study based on the EHS index), and the statistical analyst (statistics consultant) will be blinded by the intervention and control. During laser treatment, goggles are placed on the patient's eyes. The patient will not feel any heat changes or pain during the laser treatment. The device probe is used on the control side at the same time as intended on the intervention side in off mode. The patient (according to the above points) will be blind to which side of the mouth he receives the laser. The laser operator is not blind to the assignment of the laser to either side of the mouth, but the person measuring the results of the study will be blind to this assignment. Also, labels A and B are considered for both intervention and control so that the statistical analyst is blind to the end of the data analysis relative to the allocation.

Data file and statistical analysis will be shared

3 months after data collection

The above information will be made available to the public in the form of appendices along with the published article

To better understand the study findings as well as a reference for future studies.

website of the journal where the article will be published.

The data file and statistical analysis will be available to everyone