Effect of Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity and Tooth Color Post- Whitening

February 26, 2023 updated by: Cecy Martins Silva, Universidade Federal do Para

Effect of Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity and Tooth Color Post- Whitening : a Randomized, Single Blind and Split Mouth Clinical Trial.

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 topic desensitizing agents could be a alternative for the control of this adverse effects of bleaching agents. The objective of this randomized clinical study, therefore, is to evaluate the effect of glutaraldehyde-based desensitizing agent associated on tooth sensitivity and tooth color after bleaching with 35% hydrogen peroxide. 25 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 desensitizing agent helps in the control of post-bleaching sensitivity, without harming the final color obtained of patients submitted to the proposed clinical protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tooth whitening will be performed in 3 sessions with an interval of 7 days. Desensitizing agent and placebo will be applied in all sessions in a split mouth design . 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.

Application of the desensitizer or its placebo (step 3) will follow the following sequence:1. Relative insulation with cotton rolls; 2- 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.

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- baseline, T1- a week after the first session; T2- a week after the second session; T3- a week after the third session. An area of interest for color registration will be the middle third of the buccal surface of the teeth, following the 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 and CIEDE 2000 system. The region for color evaluation with the Easyshade will be standardized as the middle third of the buccal surface of the anterior teeth.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PA
      • Belém, PA, Brazil, 66087680
        • Raissa Araujo de Mesquita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLUMA
Glutaraldehyde + Hydroxyethyl methacrylate (GLUMA® Desensitizer)
Other: GLUMA DESINSITIZER
GLUTARALDEHYDE
Placebo Comparator: PLACEBO
DISTILLED WATER
Other: PLACEBO
DESTILLED WATER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of glutaraldehyde based material with or without low level laser therapy in tooth sensitivity during whitening protocol with 35 % hydrogen peroxide.
Time Frame: 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
Patients will be evaluated during 21 days.
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.
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Para

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 26, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFpara-0012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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