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

Photobiomodulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05946265
• Other study ID #: dental sensitivity
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2023
• Source: University of Nove de Julho
• Contact: Anna Carolina Ratto Tempestini Horiana, PhD
• Phone: 981999848
• Email: acrth[@]uni9.pro.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: September 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity
• Photobiomodulation

Intervention

Other:
• Photobiomodulation
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.
• simulation of Photobiomodulation
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.

Locations

Country	Name	City	State
Brazil	Anna Carolina R.T. Horliana	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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