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

NCT05946265 | Completed

• 1 other identifier: dental sensitivity
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

One hundred twenty 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 study's primary outcome 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. The impact of oral health on the participant's quality of life will also be assessed with the OHIP-14 questionnaire. 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

Conditions

Photobiomodulation; Dental Hypersensitivity

Keywords

low-level light therapy; periodontal treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Rescue medication at baseline

  baseline

• Rescue medication at 7 days

  7 days after treatment

• Rescue medication at 30 days

  30 days after treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention Group - RAR + FBM (n=56): The researcher responsible for FBM will remove the randomization envelope and apply Laser Therapy XP. All dosimetric parameters, details of sessions, and the number of FBM applications are presented in the project.

Device: Photobiomodulation

Control Group

PLACEBO COMPARATOR

Control Group - RAR + FBM simulation (n=56): 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

Device: simulation of Photobiomodulation

Interventions

Photobiomodulation DEVICE

120 patients with dentin sensibility after non-surgical scaling and root planning (SRP) will be randomly included in 2 groups: Experimental Group: SRP+ Photobiomodulation (PBM) The dosimetric parameters for the treatment included a wavelength of 660 nm applied in continuous mode with a radiant power of 100 mW (0.1 W). The irradiance ranged from 35.385 mW/cm² to 35 W/cm², with a beam area of 0.002826 cm². Each point received an exposure time of 30 seconds, resulting in a radiant exposure of 1.061 J/cm² and a total radiant energy of 3 J. The procedure involved six irradiated points per tooth, distributed across the vestibular surface (apical, middle, and cervical regions) and the palatal surface. The application technique was performed in contact, maintaining a 90-degree angle to the surface. The treatment consisted of a single session.

Intervention group

simulation of Photobiomodulation DEVICE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 or older,
• diagnosed with periodontitis and experiencing dentin hypersensitivity greater than three on the VAS scale caused by a UNC-15 periodontal probe.
• both male and female patients were included,
• without comorbidities.

You may not qualify if:

• Patients taking medications that affect gingival metabolism (e.g., cyclosporine, phenytoin, nifedipine), inflammation (e.g., corticosteroids, anti-inflammatories), or pain (analgesics/NSAIDs),
• history of photosensitivity
• allergies to any medications used in the study.
• patients who experienced any complications during the study,
• allergic reactions to materials used or to paracetamol®
• Those who took any medication not provided in the study were also excluded.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Anna Carolina R.T. Horliana

São Paulo, São Paulo, 11030-480, Brazil

Location

Related Publications (1)

• Garcia Olazabal MV, Moya LEP, Cirisola RWC, Bruno LH, Safi FT, Ando-Suguimoto ES, Longo PL, Duran CCG, Bussadori SK, Motta LJ, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT. Effect of photobiomodulation on dentin hypersensitivity: a randomized controlled double-blind clinical trial. Clin Oral Investig. 2025 Jan 24;29(1):84. doi: 10.1007/s00784-025-06149-z.

  PMID: 39853488 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Anna CR Horliana, PhD

  University of Nove de Julho

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 14, 2023
• Study Start: November 1, 2022
• Primary Completion: February 28, 2024
• Study Completion: March 28, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)