Er,Cr:YSGG Laser Bleaching on Tooth Color and Sensitivity

NCT06666920 | Completed

• 1 other identifier: 31/23-03-2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this split-mouth clinical study was to evaluate the tooth color (ΔΕab and ΔΕ00) and whiteness (ΔWID) changes, as well as tooth sensitivity (TS) induced after performing in-office tooth bleaching procedure with or without light-activation of the bleaching gel using Er,Cr:YSGG laser irradiation. Twenty patients with tooth shade A3 or darker were selected for this single-blinded, split-mouth study. The bleaching session was conducted with two 20-min sessions of a 40% hydrogen peroxide bleaching agent assisted by Er,Cr:YSGG laser (2780 nm) irradiation on one side (left) of the maxillary and mandibular teeth and without laser activation on the other hemiarch (right). ΔΕab, ΔΕ00 and ΔWID were evaluated in central incisors and canines using a clinical spectrophotometer immediately, 1 week and 1 month after the bleaching procedure. TS was evaluated pre-operatively and immediately post-operatively using a visual analogue scale (VAS).

Conditions

Tooth Discoloration; Tooth Sensitivity

Keywords

Tooth color change; Laser-assisted tooth bleaching; Spectrophotometer; Tooth sensitivity; Whiteness index

Outcome Measures

Primary Outcomes (1)

• Tooth color and whiteness changes

  Tooth color and whiteness changes will be evaluated using a clinical spectrophotometer. According to Commission Internationale de l'Eclairage Lab (CIELAB) color space tooth color change (ΔEab) using the CIELAB system was determined using equation (1): ΔEab = \[(ΔL)2 + (Δa)2 + (Δb)2\]1/2 (1) Moreover, tooth color change using the CIEDE2000 system, employing the h (hue) and C (chroma) values was calculated using equation (2): ΔE00 = \[(ΔL'/KLSL)2 + (ΔC'/KCSC)2 + (ΔH'/KHSH)2 + RT × (ΔC'/KCSC) × (ΔH'/KHSH)\]1/2 (2) The Whiteness Index for Dentistry (WID) was evaluated based on CIELAB parameters before and after the bleaching treatments, using equations (3) and (4): WID= 0.511L - 2.324a - 1.100b (3) ΔWID= WIDi - WID0 (4)

  The measurements were performed at four time points: a) before the bleaching treatment (baseline), b) immediately after the bleaching treatment, c) one week after the bleaching treatment (7 days) and d) one month after the bleaching treatment (30 days).

Secondary Outcomes (1)

• Tooth sensitivity

  Measurements were carried out before and immediately after the bleaching procedure

Study Arms (2)

Laser-assisted tooth bleaching technique

EXPERIMENTAL

The left hemiarches of the patient's dentition received laser treatment during tooth bleaching procedure

Radiation: laser irradiation

Conventional tooth bleaching technique

NO INTERVENTION

The right hemiarches of the patient's dentition received laser treatment during tooth bleaching procedure

Interventions

laser irradiation RADIATION

Immediately after applying the bleaching agent, the gel on the left upper and lower hemiarches (teeth 21-25 and 31-35) was irradiated using an Er,Cr:YSGG laser (2780 nm). Specifically, an Er,Cr:YSGG solid-state laser device (Waterlase MD Turbo, BIOLASE, Irvine, CA, USA) equipped with a Z-type glass tip (MZ8) measuring 800 μm in diameter and 6 mm in length was used. This tip was attached to the laser system's gold handpiece. The laser parameters for the treatment included an average output power of 1.25 W, a pulse duration of 700 μs (S-mode), and a pulse repetition rate of 10 Hz, without water or air flow, according to a previous study. Each tooth received two 15-s irradiation intervals, one for each 20-min session (totaling 30 s), while maintaining the laser handpiece approximately 2.5 cm from the tooth surface, perpendicular to the enamel. The gel was irradiated using a scanning mode, with the handpiece moved slowly in both horizontal and vertical directions at a speed of 2 mm/s.

Laser-assisted tooth bleaching technique

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Good overall health
• Healthy oral tissues
• Vital upper and lower anterior teeth
• No carious or non-carious lesions
• Tooth shade A3 or darker

You may not qualify if:

• Patients with direct or indirect restorations on their upper or lower anterior teeth.
• Patients using orthodontic appliances.
• Patients undergone previous bleaching treatments.
• Patients with a history of adverse reactions to peroxides.
• Patients taking opioid medications
• Patients having pacemakers.
• Patients with severe tooth discoloration due to tetracycline, trauma, fluorosis, or other causes.
• Patients with clinically verifiable dentin exposure; or those with dental sensitivity or a history of treatment for dental sensitivity.
• Smokers.
• Pregnant or lactating women.
• Patients with neurological disorders.
• Individuals taking medications that could cause photosensitivity.
• Patients with chronic or acute diseases.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Central Makedonia, 54124, Greece

Location

MeSH Terms

Conditions

Tooth Discoloration; Dentin Sensitivity

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of the Department of Operative Dentistry of Aristotle University of Thessaloniki

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 31, 2024
• Study Start: October 1, 2018
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

GR (1)