AzTrials
AzTrials

Tooth SensitivityNCT05865275

Diode Low-power Laser Before In-office Bleaching

A study testing Low-level laser treatment and tooth bleaching procedure in people with Tooth Sensitivity, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tooth Sensitivity
What is being tested?
Low-level laser treatment and tooth bleaching procedure
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteItaly
Study dates
9 Nov 2021to 20 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of study of Campania

    Naples, 83138

Other trials in Italy

About this study

Official title: The Use of Diode Low-power Laser Therapy Before of In-office Bleaching to Prevent the Bleaching-induced Tooth Sensitivity. A Clinical Study

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.

Read the detailed description

Materials and methods The sample used for this study was of 30 subjects with explicit request for teeth whitening and was conducted in agreement with a randomized double-blind and placebo controlled clinical trial. This search was led in accordance with the ethical standards of the committee responsible for human experimentation (institutional and national), and with the Helsinki Declaration of 1975, as revised in 2013. Only patients at least 18 years old with teeth of a shade darker than C2, using the shade guide of Vita Classical A1-D4®- Germany, were recruited. All patients were in good general health with maxillary and mandibular anterior teeth without caries, visible defects, and any restoration. Subjects who exhibited a negative vitality test for any teeth, from 1.4 to 2.4, were excluded from the study. Patients who used analgesics, anti-inflammatory, or antioxidant medicine to 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. None of the patients recruited reported symptoms attributable to dental sensitivity. Two weeks before the bleaching treatment, the participants underwent professional oral hygiene and received oral hygiene instructions to brush their teeth twice per day with a similar toothbrush and toothpaste during the research time. Each patient was informed, verbally and in writing, about the treatment procedures and was asked to sign an informed consent document before the study commencement. All the teeth from 1.4 to 2.4 of each patient that had to be subjected to whitening treatment were evaluated for dental sensitivity by means of the cool sensitivity test (baseline).

Cold sensitivity Test (CST): The degree of tooth sensitivity was determined using an air stimulus defined as a 3 s cold air blast (temperature range of 19-20° C) at a distance of 2-3 mm from the test site. Each tooth under examination was isolated using cotton rolls and by shielding the neighboring teeth with the gloved fingers of the operator. All patients were asked to report their degree of sensitivity for each tooth after the CST employing a visual analog scale (VAS) to objectify the degree of intensity of pain/discomfort felt, consisting of a 100-mm horizontal line on a sheet of paper with 0-10 points where the ends were represented from 0 (the left side) indicating no pain/discomfort and 10 (the right side) representing the worst possible pain never warned [14].

Patients reporting VAS values greater than 4 for at least one tooth were excluded from the study.

The in-office bleaching procedure The thirty patients selected have randomly divided into two groups (n=15) using a Random Number Generator Software by a not-clinician investigator. The mean age of the patients was similar in the two study groups (test group 23.4 ± 5.8 and placebo group 5.5 ± 6.2), as well as there was no significant difference in the sex of the participants between the two groups (8 and 7 females respectively in test and placebo group).

  • Test group: all teeth to be whitened of each patient, before bleaching, received an irradiation procedure by a LLLT using a diode laser (Soft Touch; 810 nm, 5 W, Creation). The laser probe (a fiber of 400 µm diameter) was positioned in contact mode with the enamel of the tooth to be irradiated for 30 s in continuous-wave using 0.5 W, with horizontal and vertical moving to cover the whole area. Each tooth received an energy density of 15 J/cm2. Subsequently each patient underwent the teeth whitening procedure using the protocol recommended by the product manufacturer. The gingival tissues of the teeth to be bleached were isolated from the bleaching gel using a light-cured resin dam (OpalDam Kit, Ultradent; Corsico- 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: all teeth to be whitened of each patient, before bleaching, to avoid interference psychological of patients on outcomes of study, received a preventive laser procedure applying the identical parameters used for group test except the device was kept in idle mode. Subsequently he teeth whitening procedure was identical to that of the test group.

Following the bleaching treatment, the gel was rinsed off. 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 VAS score in baseline, and who was unaware of the assigned clinical protocols, underwent again all participants of the study to CST asking them to record the degree of dental sensitivity, for each bleached tooth, perceived from immediately, to 1 h, to 24 h, and to 48 h after the end of bleaching treatment using the VAS score.

Statistical analysis To quantify the cold discomfort experience for each patient a single VAS value was considered, obtained from the sum of the individual VAS values from each tooth exposed to cold test. While, for the comparsion of discomfort between the two groups, the total VAS score of each group was used, resulting from the sum of the VAS values of each patient collected at the different study times. The VAS values of each group was confronted with each other and also compared with the baseline value of reference at different study times.The statistical analysis was performed with GraphPad Prism software version 9 (by Dotmatics, San Diego CALIFORNIA, USA.) The significance level for all tests was predetermined at p< 0.05.

Results All 30 participants completed the study. The table 1 shows the total value VAS (mean and standard deviation, SD) for each study group at different time points of the clinical trial. The comparison of the total VAS scores for each group study within the same study time revealed statistically significant values using the Wilcoxon signed-rank test in times of immediately, after 1h, and after 24 h while there was no significant difference for the VAS values 48 h after whitening treatment (Table 1 and figure 1). The comparison of VAS score of each group with the corresponding value at baseline time shows high significance for both groups in immediately and only with the equivalent VAS value of placebo group after 1 h and 24 h after whitening.

Being tested
Low-level laser treatment, tooth bleaching procedure
Keywords
in-office bleaching, tooth sensitivity, low-level laser, therapy (LLLT), pain.
Medical subject headings
Dentin Sensitivity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-level laser treatmentDevice

    Also called use of low-power diode laser before tooth bleaching

    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

  • tooth bleaching procedureOther

    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.

Study groups in NCT05865275
Study groupRoleWhat they receive
Test groupExperimentalit is the group for testing the effectiveness of low power of a diode laser on the onset of dental sensitivity
Receives: Device: Low-level laser treatment; Other: tooth bleaching procedure
Placebo groupPlacebo comparatorthis represents the control group with tooth bleaching without preliminary laser treatment
Receives: Other: tooth bleaching procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. baseline

    The total scores in each study group of dental hypersensitivity

    Measured: time 0

  2. Immediately

    The total scores in each study group of dental hypersensitivity

    Measured: Immediately after the end of bleaching treatment

  3. After 1 hour

    The total scores in each study group of dental hypersensitivity

    Measured: to 1 h after the end of bleaching treatment

  4. After 24 hours

    The total scores in each study group of dental hypersensitivity

    Measured: to 24 h after the end of bleaching treatment

  5. After 48 hours

    The total scores in each study group of dental hypersensitivity

    Measured: to 48 h after the end of bleaching treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start9 Nov 2021
  3. Primary completion13 Dec 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized double-blind and placebo-controlled clinical trial study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05865275
Sponsor's protocol ID
001
Status last verified
May 2023
First submitted
29 Apr 2023
Last updated
22 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD will be registered in an exel file and the same will be upload on an virtual drive as dropbox or google drive

Publications

  • 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.

    PubMed 26877590
  • 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.

    PubMed 36605144
  • 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.

    PubMed 32259412

Questions about this trial

What is this clinical trial studying?

A study testing Low-level laser treatment and tooth bleaching procedure in people with Tooth Sensitivity, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

baseline (time frame: time 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05865275, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in