Clinical trial NCT05946265: 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 Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photobiomodulation
Dental Hypersensitivity
Keywords: low-level light therapy
periodontal treatment
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain (VAS) in baseline
timeFrame: baseline
measure: Pain (VAS) in 7 days
timeFrame: 7 days after treatment
measure: Pain (VAS) in 30 days
timeFrame: 30 days after treatment
Secondary outcomes:
measure: Rescue medication at baseline
timeFrame: baseline
measure: Rescue medication at 7 days
timeFrame: 7 days after treatment
measure: Rescue medication at 30 days
timeFrame: 30 days after treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Anna Carolina R.T. Horliana
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Anna CR Horliana, PhD
role: STUDY_CHAIR
References: