Evaluation of Tooth Sensitivity After Scaling and Root Planing Treated With Photobiomodulation

Study Overview
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Brief Summary
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Forty-four patients with dentin sensibility after non-surgical scaling and root planning (SRP) will be randomly included in 2 groups: Experimental Group: SRP+ Photobiomodulation (PBM) (660nm, 100W, area 0,5cm2, 200w/cm2, 30 seconds, 3 J, 6J/cm2. The primary outcome of the study will be the assessment of dentinal sensitivity after 7 days of RAR measured with the visual analog scale (VAS). The cutoff of VAS is 3. Also, it will be assessed the impact of oral health on the participant's quality of life, with the OHIP-14 questionnaire. The use of analgesics (paracetamol) will be prescribed as needed and the amount of medication will be calculated. These outcomes will be evaluated after 7 days and 1 month of application

Detailed Description
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Objective: To evaluate tooth sensitivity after photobiomodulation in sensitive scaling and root planning treated teeth. Study design: Randomized, controlled, double-blind split-mouth clinical trial. Methods: Forty-four patients with dentin sensibility after non-surgical scaling and root planning (SRP) will be randomly included in 2 groups: Experimental Group: SRP+ Photobiomodulation (PBM) (660nm, 100W, area 0,5cm2, 200w/cm2, 30 seconds, 3 J, 6J/cm2. The primary outcome of the study will be the assessment of dentinal sensitivity after 7 days of RAR measured with the visual analog scale (VAS). The cutoff of VAS is 3. Also, it will be assessed the impact of oral health on the participant's quality of life, with the OHIP-14 questionnaire. The use of analgesics (paracetamol) will be prescribed as needed and the amount of medication will be calculated. These outcomes will be evaluated after 7 days and 1 month of application. If the data are normal, they will be submitted to the ANOVA test - one way. Data will be presented as means ± SD and the p-value will be set to < 0.05.

Official Title
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Evaluation of Tooth Sensitivity After Scaling and Root Planing Treated With Photobiomodulation: a Randomized Controlled Split-mouth Double-blind Clinical Trial

Conditions
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Photobiomodulation, Dental Hypersensitivity

Intervention / Treatment
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* Other: Photobiomodulation
* Other: simulation of Photobiomodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age, both genders, without comorbidities will be included. Exclusion Criteria: Patients who are taking drugs that affect gingival metabolism (cyclosporine, phenytoin, nifedipine), inflammatory drugs (example: corticosteroids or non-steroidal anti-inflammatory drugs), or analgesics, pregnant or lactating women, history of photosensitivity, allergic to paracetamol will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Forty-four patients with dentin sensibility after non-surgical scaling and root planning (SRP) will be randomly included in 2 groups: Experimental Group: SRP+ Photobiomodulation (PBM) (660nm, 100W, area 0,5cm2, 200w/cm2, 30 seconds, 3 J, 6J/cm2. The primary outcome of the study will be the assessment of dentinal sensitivity after 7 days of RAR measured with the visual analog scale (VAS). The cutoff of VAS is 3. Also, it will be assessed the impact of oral health on the participant's quality of life, with the OHIP-14 questionnaire. The use of analgesics (paracetamol) will be prescribed as needed and the amount of medication will be calculated. These outcomes will be evaluated after 7 days and 1 month of application.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intervention Group - RAR + FBM (n=22): The researcher responsible for FBM will remove the randomization envelope and apply Laser Therapy XP at the points indicated in Figure 2. All dosimetric parameters, details of sessions, and the number of FBM applications are described in Table 2. | Other: Photobiomodulation<br>* Forty-four patients with dentin sensibility after non-surgical scaling and root planning (SRP) will be randomly included in 2 groups: Experimental Group: SRP+ Photobiomodulation (PBM) (660nm, 100W, area 0,5cm2, 200w/cm2, 30 seconds, 3 J, 6J/cm2.<br>|
| Placebo Comparator: Control Group<br>Control Group - RAR + FBM simulation (n=22): Simulation of the use of FBM will be carried out identically to the Experimental group. The person responsible for applying the FBM will simulate irradiation by positioning the devices in the same locations described for the FBM group, however, the laser pointer will be turned off and the sound of the device will be recorded to mimic the use of the equipment and the participant will not identify the group to be used. who belongs. In this trial, we have no criteria for discontinuing or modifying allocated interventions because no harm is expected with this intervention. The study flowchart presents the details of the project | Other: simulation of Photobiomodulation<br>* Simulation of the use of FBM will be carried out identically to the Experimental group. The person responsible for applying the FBM will simulate irradiation by positioning the devices in the same locations described for the FBM group, however, the laser pointer will be turned off and the sound of the device will be recorded to mimic the use of the equipment and the participant will not identify the group to be used. who belongs. In this trial, we have no criteria for discontinuing or modifying allocated interventions because no harm is expected with this intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (VAS) in baseline | It will be evaluated through the application of the Visual Analog Scale (VAS) in which we will have a ruler with a length of 10 cm, without markings. One of the extremes is marked 0, and the other 100 which means respectively no pain and unbearable pain. This ruler will be the same for all participants (a plasticized ruler where the patient marks with a permanent pen the amount of pain felt at that moment and this amount is measured in millimeters and the value noted in the patient's chart). Instructions on marking will always be given to the patient by the same operator. Each patient will be instructed to mark with a vertical line the point that best corresponds to the intensity of pain at the time of assessment . Without the presence of the patient, the operator will always measure with the same ruler, recording this data on the cards. This analysis will occur on all queries. | baseline | 
| Pain (VAS) in 7 days | It will be evaluated through the application of the Visual Analog Scale (VAS) in which we will have a ruler with a length of 10 cm, without markings. One of the extremes is marked 0, and the other 100 which means respectively no pain and unbearable pain. This ruler will be the same for all participants (a plasticized ruler where the patient marks with a permanent pen the amount of pain felt at that moment and this amount is measured in millimeters and the value noted in the patient's chart). Instructions on marking will always be given to the patient by the same operator. Each patient will be instructed to mark with a vertical line the point that best corresponds to the intensity of pain at the time of assessment . Without the presence of the patient, the operator will always measure with the same ruler, recording this data on the cards. This analysis will occur on all queries. | 7 days after treatment | 
| Pain (VAS) in 30 days | It will be evaluated through the application of the Visual Analog Scale (VAS) in which we will have a ruler with a length of 10 cm, without markings. One of the extremes is marked 0, and the other 100 which means respectively no pain and unbearable pain. This ruler will be the same for all participants (a plasticized ruler where the patient marks with a permanent pen the amount of pain felt at that moment and this amount is measured in millimeters and the value noted in the patient's chart). Instructions on marking will always be given to the patient by the same operator. Each patient will be instructed to mark with a vertical line the point that best corresponds to the intensity of pain at the time of assessment . Without the presence of the patient, the operator will always measure with the same ruler, recording this data on the cards. This analysis will occur on all queries. | 30 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue medication at baseline | Another parameter analyzed will be the number of analgesics ingested. At the beginning of the research, a pack of paracetamol® will be given to each participant , and use will be performed in case of pain. At the end of the experiment, the number of pills will be evaluated as another pain measurement parameter (drug tablet return). A procedure will be carried out to monitor the adherence of the participants (e.g., all patients will be asked to take the pack of analgesics to the consultation to check how they are being used). | baseline | 
| Rescue medication at 7 days | Another parameter analyzed will be the number of analgesics ingested. At the beginning of the research, a pack of paracetamol® will be given to each participant , and use will be performed in case of pain. At the end of the experiment, the number of pills will be evaluated as another pain measurement parameter (drug tablet return). A procedure will be carried out to monitor the adherence of the participants (e.g., all patients will be asked to take the pack of analgesics to the consultation to check how they are being used). | 7 days after treatment | 
| Rescue medication at 30 days | Another parameter analyzed will be the number of analgesics ingested. At the beginning of the research, a pack of paracetamol® will be given to each participant , and use will be performed in case of pain. At the end of the experiment, the number of pills will be evaluated as another pain measurement parameter (drug tablet return). A procedure will be carried out to monitor the adherence of the participants (e.g., all patients will be asked to take the pack of analgesics to the consultation to check how they are being used). | 30 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-level light therapy, periodontal treatment