Photobiomodulation Before or After Tooth Whitening

NCT06518629 | Completed DMC

• 1 other identifier: Universidade Federal do Pará
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to evaluate the effect of photobiomodulation (PBM) applied before or after in-office tooth whitening in reducing tooth sensitivity (TS) and color change. Sixty-six patients aged between 18 and 28 years old, of both sexes, with good oral and general health will be selected for the study. A randomization process will be carried out to allocate participants into the three different groups: FBM-Before, FBM-After and Placebo. All groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whitness HP, FGM, Joinville, SC, Brazil). Three whitening sessions will be carried out, considering a seven-day interval between sessions. TS will be measured using a visual analogue scale (VAS) and a five-point numerical rating scale (NRS), while shade change will be assessed using a spectrophotometer: before the bleaching treatment (T0), after the first (T1), second (T2). ) and third (T3) weeks of treatment and 30 days (T4) after the end of the bleaching treatment.

Conditions

Tooth Sensitivity; Tooth Bleaching; Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Tooth sensitivity

  To assess pain sensitivity, patients will be instructed to fill out a form to record tooth sensitivity, based on individual pain perception. This form will be delivered at each whitening session, and will be returned to the researcher at the next appointment, that is, always one week after each whitening session.

  21 days

Secondary Outcomes (1)

• Color change

  51 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Only in-office tooth whitening will be performed. Patients will not undergo additional treatments, however, a simulation of the application of FBM will be performed before and after each CD session. The low-power laser (Therapy EC, DMC, São Carlos, SP, Brazil) will be positioned perpendicularly, in contact, over the cervical and apical region of each tooth included in the whitening treatment. During the simulation, the equipment will not be activated, that is, irradiation will not be carried out.

Other: Photobiomodulation with low power laser

FBM-Before

EXPERIMENTAL

Low power laser will be used immediately before CD. The energy supplied to each tooth will be 4J, using infrared light (IF) at 808 nm (± 10 nm) at two perpendicular points (located in the apical and cervical region) on the buccal surface of the incisors, canines and premolars. The laser will be operated in continuous mode and an energy of 2J will be applied to each point. The protocol that will be used to treat tooth sensitivity was recommended by the equipment manufacturer. Immediately after each whitening treatment session, a FBM simulation will be performed, in the same way as described for the Placebo group.

Other: Photobiomodulation with low power laser

FBM-After

EXPERIMENTAL

The low-power laser will be used immediately after tooth whitening. The FBM protocol will occur in the same way as described for the FBM-Before group. The FBM simulation will occur before the CD session begins and will occur in the same way as described for the Placebo group.

Other: Photobiomodulation with low power laser

Interventions

Photobiomodulation with low power laser OTHER

All groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whitness HP, FGM, Joinville, SC, Brazil). Three whitening sessions will be carried out, considering a seven-day interval between sessions.

Also known as: Tooth Bleaching

FBM-After; FBM-Before; Placebo

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers of both sexes, in good oral and general health.
• The upper right canine should be classified as color A2 or darker, according to the Vita Classical scale (VITA Zahnfabrik, Bad Sackingen, Germany).

You may not qualify if:

• Active caries or periodontal disease
• Visible cracks in upper or lower anterior teeth
• Evident malocclusion, restorations and prosthetics in anterior teeth
• Gastroesophageal disorders
• Severe internal discoloration of the tooth (tetracycline, fluorosis or pulped teeth)
• Exposure dentin in anterior and/or posterior teeth
• Parafunctional habits
• Tooth sensitivity, previous bleaching treatment or orthodontic treatment
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Elma Vieira Takeuchi

Belém, Pará, 66093541, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Low-Level Light Therapy; Tooth Bleaching

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Esthetics, Dental; Dentistry

Study Design

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

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 21, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

BR (1)