Clinical trial NCT04537754: Clinical Comparison of LED- and Diode Laser-activated Bleaching
Official title: Clinical Comparison of LED- and Diode Laser-activated Bleaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Color; Change Teeth, Posteruptive
Keywords: In-office tooth bleaching
Diode laser
LED
color change
tooth-sensitivity
temperature
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To clinically compare the effects of LED- or Diode laser-activated bleaching on colour change, tooth-sensitivity, gingival-irritation and temperature variation over 9-months.

Thirty-five patients with tooth colour A2 or higher will be included in the study. In a split-mouth design, using a 35% HP bleaching agent (Whiteness HP); one side of each mouth will be randomly activated by a diode laser (Epic X) and the other side by an LED (Radii Plus) light-source. During bleaching, the temperature variations will be recorded using a thermocouple from the buccal surface of canine teeth. Colour change (ΔSGU, ΔE) will be evaluated by subjective (Vita classic/bleached guide) and objective methods (spectrophotometry) before treatment and immediately, 48h, 1 week, 1, 6, 9 months after. Tooth-sensitivity and gingival- irritation will be assessed by visual analogue scale (VAS) and Gingival Index.

Detailed description: Objective: The aim of this split-mouth, randomized clinical study is to evaluate the effect of LED or Diode laser-activated bleaching applications on colour change, tooth sensitivity, gingival irritation and temperature variation with 35% hydrogen peroxide bleaching gel after 9 months. Material and Methods: Thirty-five patients with anterior teeth without caries and no restoration will be included in this study. In a split-mouth design, a bleaching agent containing 35% HP (Whiteness HP, FGM) will be used, one side of each jaw will be activated by a diode laser (Epic X, Biolase) and the other side will be activated by an LED (Radii Plus, SDI) light source. During the bleaching treatments, the temperature variations will be recorded using a thermocouple (DT-3891G K type Thermometer datalogger, CEM Instruments) from the buccal surface of canine teeth. Tooth sensitivity will be assessed by Visual Analogue Scale (VAS) before the treatment and during, immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer) before the treatment and immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change (ΔE and ΔSGU) will be performed by analysis of variance in repeated measurements. Multiple comparisons will be evaluated by Bonferroni test. Temperature variation will be evaluated by t-test in dependent groups. Tooth sensitivity will be analyzed using Friedman test. Wilcoxon test will be used to compare two light sources (Diode Laser/ LED) in each time period (p\< 0.05).

Eligibility criteria: Inclusion Criteria:

* healthy vital anterior teeth without restorations which have A2 or darker tooth shade on Vita Classical Scale (Vita Classical Scale, VITA Zahnfabrik, Bad Säckingen, Germany).

Exclusion Criteria:

* Pregnant or lactating woman smokers Participants with periodontal diseases, tooth sensitivity internal tooth discoloration (tetracycline/ fluorosis stains), exposed engine, peroxides allergy malpositioned teeth

Primary outcomes:
measure: Colour change
timeFrame: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
measure: temperature
timeFrame: Procedure (During the bleaching treatments)
measure: Tooth sensitivity
timeFrame: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Aybuke Uslu
Study officials:
affiliation: Hacettepe University
name: A. Ruya Yazici, Prof.
role: STUDY_DIRECTOR
References: