Evaluation of tooth sensitivity after scaling and root planing treated with photobiomodulation: a randomized controlled split-mouth double-blind clinical protocol

Abstract

It is well known that hypersensitivity affects patients recently treated with scaling and root planing. Some studies have demonstrated that photobiomodulation (PBM) can alleviate dentinal hypersensitivity by modulating pain. However, to date, there is no established protocol for its application after scaling and root planning.  To evaluate tooth hypersensibility 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) and Control Group: Scaling and root planning +FBM simulation. After 7 days of scaling and root planning, all patients will be evaluated for hypersensibility. The cutoff of VAS will be 3. These patients will be included in the study. The primary outcome of the study will be the assessment of dentin hypersensitivity after 7 days of RAR measured with the visual analog scale (VAS). 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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT05946265 (initial release: July 2023)

Funding Statement

The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Universidad Católica del Uruguay Comite de etica en investigacion statement number: 30052022 consent form: written

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Deidentified research data will be made publicly available when the study is Completed and published.

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