Diode Low-power Laser Before In-office Bleaching

NCT05865275 | Completed DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The aim of study was to investigate the effectiveness of low-level laser therapy (LLLT) use before in-office bleaching to prevent risk and intensity of tooth sensitivity. Methods: thirty patients were selected for this clinical trial. Before bleaching procedures with 38 % hydrogen peroxide, the participants were randomly divided into two groups of 15 subjects. Test group: the patients teeth received a preliminary LLLT procedure by an 810 nm diode laser with 0.5 Watt for 30 s for an energy density of 15 J/cm2 and a group placebo: the patients received the same preliminary LLLT but with the device switch off. All patients were instructed to report their cold sensitivity experiences immediately, 1 h, 24 h, and 48 h after the end of bleaching by a visual analog scale score between 0-10.

Conditions

Tooth Sensitivity

Keywords

in-office bleaching; tooth sensitivity; low-level laser; therapy (LLLT); pain.

Outcome Measures

Primary Outcomes (5)

• baseline

  The total scores in each study group of dental hypersensitivity

  time 0

• Immediately

  The total scores in each study group of dental hypersensitivity

  Immediately after the end of bleaching treatment

• After 1 hour

  The total scores in each study group of dental hypersensitivity

  to 1 h after the end of bleaching treatment

• After 24 hours

  The total scores in each study group of dental hypersensitivity

  to 24 h after the end of bleaching treatment

• After 48 hours

  The total scores in each study group of dental hypersensitivity

  to 48 h after the end of bleaching treatment

Study Arms (2)

Test group

EXPERIMENTAL

it is the group for testing the effectiveness of low power of a diode laser on the onset of dental sensitivity

Device: Low-level laser treatment; Other: tooth bleaching procedure

Placebo group

PLACEBO COMPARATOR

this represents the control group with tooth bleaching without preliminary laser treatment

Other: tooth bleaching procedure

Interventions

Low-level laser treatment DEVICE

a single preliminary treatment for a few seconds for each tooth using low level diode laser before of tooth bleaching could reduce risk to arise of tooth sensitivity

Also known as: use of low-power diode laser before tooth bleaching

Test group

tooth bleaching procedure OTHER

The gingival tissues of the teeth to be bleached were isolated from the bleaching gel using a light-cured resin dam (OpalDam Kit, Ultradent; Milan, Italy). A 38 % ready-to-use Hydrogen peroxide-containing gel (The Smile® Strong, Italy) was applied from the first premolar right to the first premolar left of both jaws for a total period of 20 minutes for a 1 single whitening session.

Placebo group; Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with teeth of a shade darker than C2, using the shade guide of Vita Classical A1-D4®- Germany
• patients in good general health with maxillary and mandibular anterior teeth without caries, visible defects, and any restoration.

You may not qualify if:

• Subjects who exhibited a negative vitality test for any teeth, from 1.4 to 2.4,
• Patients who used analgesics, anti-inflammatory, or antioxidant medicine for therapeutic purposes and those with smoking habits, also were excluded from the study as well as patients with bruxism habits or with any pathologic defect such as gingival recession or dentin exposure.
• Patients with symptoms attributable to dental sensitivity.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of study of Campania

Naples, 83138, Italy

Location

Related Publications (3)

• Ahrari F, Akbari M, Mohammadpour S, Forghani M. The efficacy of laser-assisted in-office bleaching and home bleaching on sound and demineralized enamel. Laser Ther. 2015 Dec 30;24(4):257-64. doi: 10.5978/islsm.15-OR-15.

  PMID: 26877590 BACKGROUND

• Naghsh N, Kachuie M, Bijari M, Birang R. Evaluation of the effects of 980 and 810-nm high-level diode lasers in treating dentin hypersensitivity: A double-blinded randomized clinical trial. Dent Res J (Isfahan). 2022 Nov 17;19:96. eCollection 2022.

  PMID: 36605144 BACKGROUND

• Mendez Romero JM, Villasanti Torales UA, Villalba Martinez CJ. Efficacy of laser application in dental bleaching: A randomized clinical controlled trial. Am J Dent. 2020 Apr;33(2):79-82.

  PMID: 32259412 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity; Pain

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• rossella femiano

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

• vincenzo grassia

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * an investigator was employed for patient recruitment and to perform preliminary sensitivity tests at baseline for all selected patients (baseline) * a non-clinical investigator was used to divide the patients into two study groups using random distribution software. The laser procedure and the whitening procedure were performed by two different clinical operators who were not aware of the organization of the two study groups. Subsequently, the first operator, already employed to collect scores in baseline, and who was unaware of the assigned clinical protocols, underwent again all participants of the study to sensitivity Test asking them to record the degree of dental sensitivity, for each bleached tooth, perceived from immediately, to 1 h, to 24 h, and 48 h after the end of bleaching treatment using the score.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate Professor

Model Details: A randomized double-blind and placebo-controlled clinical trial study

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 18, 2023
• Study Start: November 9, 2021
• Primary Completion: December 13, 2022
• Study Completion: December 20, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be avaible after article publication with no time limitation
• Access Criteria: all data will be avaible contacting corresponding author indicated in the published article

Locations

IT (1)