Evaluation of the adjunctive effect of photobiomodulation therapy with Nd: YAG laser(1064nm) on decrease of lower lip paresthesia and dysesthesia in patients with inferior alveolar nerve damage

Determining and comparing the auxiliary effect of using low level Nd:YAG laser on reducing lower lip paresthesia and dysesthesia in case and control groups and also based on the referrals from the time of the accident

A controlled, parallel-group, double-blind, randomized clinical trial on 50 patients. A table of random numbers will be used for randomization.

In this research, the study subjects will be selected based on the inclusion criteria among the patients referred to Tabriz Dental Faculty who have lower lip paresthesia or dysesthesia problem. After determining the samples, obtaining written consent and explaining the method and purpose of the study, the demographic information form is completed for each patient separately. Participants in both groups are subjected to low level laser therapy by Nd:YAG laser for 10 sessions. In the case group, laser therapy will be performed in a real way, and in the control group, the off laser will be used with a completely similar method. Blinding will be done for the participants, the researcher and the outcome assessor and the data analyst.

Paresthesia and dysesthesia of the lower lip, which are classified as 1, 2, and 3 in the Sunderland classification, lack of previous intervention related to nerve damage

First, the patients are divided into two groups, over 6 months and under 6 months, based on the duration of the injury, and then they are randomly divided into case and control groups. In the case group, patients receive routine treatment plus low level laser therapy, and in the control group, patients receive routine treatment plus placebo.

The main outcomes of the study include visual analogue scale (VAS) index and two-point discrimination test.

The randomization method is simple and its unit is individual. The randomization tool will be a table of random numbers. Based on this, the type of intervention will be marked with code A (real laser therapy) and code B (placebo) and will be placed inside sealed envelopes. Then the envelopes will be placed in a bag and mixed. The envelopes will be randomly taken out of the bag and will be presented to the relevant intervention patients by observing the intervention code. None of the patients will be informed about the intervention of another patient.

In this study, it will be explained to the patients that there is a possibility of their placement in the real or fake laser therapy group, but the patients will not know their group and the laser device will be used in both groups. Patients wear blindfolds during laser therapy to protect them from laser radiation and do not notice the real or fake laser therapy. Laser therapy is performed by a person who has no knowledge of real or fake laser therapy (only the aiming beam is turned on) and evaluates the results of the study in each session. Data analysis will also be done by a person who does not know about the groups

All data is potentially shareable after de-identifying individuals.

The access period starts from 2023

All people can apply for study documents.

The data of this study can be used to investigate the effect of low level laser therapy in patients who only have paresthesia or dysesthesia of the lower lip.

Meghdad Eslami 0098 9148528993

After submitting the application, the study documentation file will be sent as soon as possible