Effect of Low Power Laser and Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity, Tooth Color and Its Impact on Post-whitening Quality of Life.

Sponsor

Universidade Federal do Para (Other)

Overall Status

Recruiting

CT.gov ID

NCT05309967

Collaborator

(none)

Enrollment

Location

Arms

22.6

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tooth whitening is one of the most indicated aesthetic procedures in dentistry and there is evidence that it interferes with aspects of patients' quality of life. However, the sensitivity, associated with the post-procedure period, challenges clinicians and researchers. The use of low level laser therapy (LLLT) associated or not with other desensitizing agents presents positive results for the control of this adverse effect of bleaching agents. The objective of this randomized clinical study, therefore, is to evaluate the effect of glutaraldehyde-based desensitizing agent associated or not with LLLT on tooth sensitivity, tooth color and the impact on quality of life after bleaching with 35% hydrogen peroxide. 52 patients will be selected divided into two groups for a double-blind and split-mouth study. Among the results it is expected: that the use of glutaraldehyde alone and/or associated with LLLT helps in the control of post-bleaching sensitivity, without harming the final color obtained and that, with this, improve the quality of life of patients submitted to the proposed clinical protocol.

Condition or Disease	Intervention/Treatment	Phase
Dentin Sensitivity	Device: LOW LEVEL LASER THERAPHY Other: GLUMA DESINSITIZER Other: PLACEBO Other: LASER AND GLUMA	N/A

Detailed Description

Tooth whitening will be performed in 3 sessions with an interval of 7 days. Desensitizing agents and/or LLLT will be applied in all sessions. All groups will receive in-office bleaching treatment according to the steps described below:1 Prophylaxis; 2- Application of gingival barrier; 3- Application of the desensitizing product or placebo in accordance with the established groups; 4- Handling the bleaching material following the manufacturer's instructions: applications of whiteness HP35% bleaching gel for 15 minutes each, totaling 45 minutes; 5- Final removal of the whitening gel and the gingival barrier followed by washing with water; 6- Polishing of surfaces teeth with felt disk and diamond paste; 7- Application of the Laser or its simulation.

Application of the desensitizer or its placebo (step 3) will follow the following sequence:1. Relative insulation with cotton rolls; two- Active application of the product on the buccal surfaces of all teeth with the aid of a Microbrush for 10 seconds.; 3- Wait 60 seconds and apply a light jet of air until the tooth surface is no longer shiny; 4- Wash with water for 10 seconds.

Low-level laser therapy will be performed in step 7 described in the Tooth whitening section, after the end of each session. In the groups that will receive laser therapy, the application will be adopted at three points perpendicular to the long axis of the teeth: on the buccal surface in the middle and cervical portions of the dental crown and an apical point towards the tooth root. Infrared spectrum will be used with a wavelength of 808nm applied at each point 1 J/cm², for 10 seconds. The LLLT simulation will be performed with the approach of the laser tip, but without the emission of light. To assess the patient's perception of pain, participants will be provided with a questionnaire to be filled out daily for 21 days from the first whitening treatment session. The criteria are based on the personal perception of the pain threshold, related to the level of sensitivity caused by bleaching treatment. The visual analogue scale (VAS) will be adopted as a reference. Numerical scale on which the number 0 (zero) corresponds to total absence of pain and 10 (ten) to maximum bearable pain.

The color records of the bleached teeth will be performed by a single evaluator who will do it session :T0- in the first session, before T1- in the times after the first session; T2- after the second session; T3- after the third session; T4- one week after the last session and T5- 6 months after the last session. An area of interest for color registration will be the middle third of the buccal surface of the teeth, the from the guidelines of the American Dental Association. Visual analysis will be performed using a Vita Classical scale following a color scale order organized by value. A second color analysis will be performed with the aid of a spectrophotometer that acts according to the CIELab system. The region for color evaluation with the Easyshade will be standardized as the middle third of the buccal surface of the anterior teeth. The measurement of the impact on quality of life related to oral health (Quality of Life Related to Oral Health) will be carried out using an adapted oral health profile (Oral Health Impact Profile) developed for the evaluation of dental whitening. The session consists of 14 questions and must be applied before the first whitening session, one month after the end of the whitening treatment and 6 months after the start of treatment.

the validated Portuguese version 33 of the selected OHIP-49 options will be used. Each answer contains five alternatives and values are assigned to each one of: 0- never or not applicable; 1 resale; 2- sometimes; 3- often and 4- always.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

It is a split mouth study composed of two main groups and each participant of theses two groups will have their mouth divided in other two groups.It is a split mouth study composed of two main groups and each participant of theses two groups will have their mouth divided in other two groups.

Masking:

Double (Participant, Investigator)

Masking Description:

For the double-blind study, the evaluator and the patient will be blinded. The bleaching procedure and the therapies under study will be performed by one operator and will only involve one evaluator not participant in the randomization and without knowledge of the interventions applied in the groups. The evaluator will be responsible for measuring and tabulating information regarding sensitivity, color analysis and the impact on patients' quality of life. The desensitizer and its placebo will be placed in similar containers so that they cannot be identified by the volunteers. The laser simulation will be performed by positioning the equipment tip on the tooth surface, keeping the same positions and application time of the laser, but without its activation. Only the simulation of the sound emitted by the laser will be fulfilled.

Primary Purpose:

Supportive Care

Official Title:

Effect of Low Power Laser and Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity, Tooth Color and Its Impact on Post-whitening Quality of Life: Clinical, Randomized,Double Bind and Split Mouth Study.

Actual Study Start Date :

Mar 13, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: LASER Diode laser (Gallium and Aluminum Arsenide) (ArGaAl) acting on the infrared with a wavelength of 808 nm.	Device: LOW LEVEL LASER THERAPHY LASER
Experimental: GLUMA Glutaraldehyde + Hydroxyethyl methacrylate (GLUMA® Desensitizer)	Other: GLUMA DESINSITIZER GLUTARALDEHYDE
Placebo Comparator: PLACEBO DISTILLED WATER	Other: PLACEBO DESTILLED WATER
Active Comparator: GLUMA AND LASER LASER AND GLUMA® Desensitizer	Other: LASER AND GLUMA COMBINATION OF LOW LEVEL LASER THERAPY AND GLUMA DESENSITIZER

Outcome Measures

Primary Outcome Measures

Use of glutaraldehyde based material with or without low level laser therapy in tooth sensitivity during whitening protocol with 35 % hydrogen peroxide. [Patients will be evaluated during 21 days.]
Self-reported pain intensity will be assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation will be performed by each patient, according to a numeric visual analog scale, as follows: 0 - 10. Where 0 correspond to no pain and 10 the most severe pain that patient have been ever identified
Use of glutaraldehyde based material with or without low level laser therapy in patient´s quality of life after whitening protocol with 35 % hydrogen peroxide. [6 months]
A questionnaire will be applied before the bleaching treatment, after the completion of the bleaching treatment and 6 months after bleaching as a follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy incisors, canines and premolars;
Do not having a diagnosis of dental hypersensitivity.
Do not have been at desensitizing treatment in the past two years.
Do not have been done dental whitening treatment.

Exclusion Criteria:

Patients undergoing orthodontic treatment;
Presence of periodontal disease;
Presence of cracks or fractures in the teeth
Presence of restorations and prostheses in anterior teeth;
Presence of extensive restorations and/or deep in molars;
Patients with serious dental darkening internal or external ;
Presence of exposed dentin.
Pregnant and lactating women.
Patients on active treatment whom are using anti-inflammatory drugs and painkillers.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Raissa Araujo de Mesquita	Belém	PA	Brazil	66087680

Sponsors and Collaborators

Universidade Federal do Para

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Cecy Martins Silva, Associate Professor, Universidade Federal do Para

ClinicalTrials.gov Identifier:

NCT05309967

Other Study ID Numbers:

UFpara-0012

First Posted:

Apr 4, 2022

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cecy Martins Silva, Associate Professor, Universidade Federal do Para

Quality-Adjusted Life Years

Tooth Bleaching

Additional relevant MeSH terms:

Dentin Sensitivity

Hypersensitivity

Study Results

No Results Posted as of Apr 4, 2022