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

NCT ID: NCT05946265

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-03-28

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

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: 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). 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.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.

Conditions

Photobiomodulation; Dental Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: 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.

Control Group

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

Group Type: PLACEBO_COMPARATOR

simulation of Photobiomodulation

Intervention Type: 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.

Interventions

Photobiomodulation

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 Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Anna Carolina Ratto Tempestini Horliana

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna CR Horliana, PhD

Role: STUDY_CHAIR

University of Nove de Julho

Locations

Anna Carolina R.T. Horliana

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39853488 (View on PubMed)

Other Identifiers

dental sensitivity

Identifier Type: -

Identifier Source: org_study_id