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

Primary Purpose

Photobiomodulation, Dental Hypersensitivity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation
simulation of Photobiomodulation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photobiomodulation focused on measuring low-level light therapy, periodontal treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anna Carolina R.T. Horliana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
June 18, 2023
Last Updated
August 25, 2023
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05946265
Brief Title
Evaluation of Tooth Sensitivity After Scaling and Root Planing Treated With Photobiomodulation
Official Title
Evaluation of Tooth Sensitivity After Scaling and Root Planing Treated With Photobiomodulation: a Randomized Controlled Split-mouth Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photobiomodulation, Dental Hypersensitivity
Keywords
low-level light therapy, periodontal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Immediately after periodontal treatment, the researcher responsible for applying the FBM will remove and open 1 envelope and perform the indicated procedure (FBM or simulation). Only this researcher will know the intervention applied to each patient. All other investigators will be blinded to the intervention.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Photobiomodulation
Intervention 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.
Intervention Type
Other
Intervention Name(s)
simulation of Photobiomodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain (VAS) in baseline
Description
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.
Time Frame
baseline
Title
Pain (VAS) in 7 days
Description
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.
Time Frame
7 days after treatment
Title
Pain (VAS) in 30 days
Description
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.
Time Frame
30 days after treatment
Secondary Outcome Measure Information:
Title
Rescue medication at baseline
Description
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).
Time Frame
baseline
Title
Rescue medication at 7 days
Description
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).
Time Frame
7 days after treatment
Title
Rescue medication at 30 days
Description
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).
Time Frame
30 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Carolina Ratto Tempestini Horiana, PhD
Phone
981999848
Ext
5513
Email
acrth@uni9.pro.br
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Victoria Garcia Olazabal, Ms
Phone
99923439
Ext
598
Email
garciaolazabal@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna CR Horliana, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
Facility Information:
Facility Name
Anna Carolina R.T. Horliana
City
São Paulo
State/Province
SP
ZIP/Postal Code
11030-480
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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