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

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
GLUMA DESINSITIZER
PLACEBO
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dentin Sensitivity focused on measuring Tooth Bleaching, dentin adhesives, tooth sensitivity

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Raissa Araujo de Mesquita

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLUMA

PLACEBO

Arm Description

Glutaraldehyde + Hydroxyethyl methacrylate (GLUMA® Desensitizer)

DISTILLED WATER

Outcomes

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
March 15, 2022
Last Updated
February 26, 2023
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT05309967
Brief Title
Effect of Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity and Tooth Color Post- Whitening
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 13, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
Tooth Bleaching, dentin adhesives, tooth sensitivity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a split mouth study composed of two groups randomized between left and right sides.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLUMA
Arm Type
Experimental
Arm Description
Glutaraldehyde + Hydroxyethyl methacrylate (GLUMA® Desensitizer)
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
DISTILLED WATER
Intervention Type
Other
Intervention Name(s)
GLUMA DESINSITIZER
Intervention Description
GLUTARALDEHYDE
Intervention Type
Other
Intervention Name(s)
PLACEBO
Intervention Description
DESTILLED WATER
Primary Outcome Measure Information:
Title
Use of glutaraldehyde based material with or without low level laser therapy in tooth sensitivity during whitening protocol with 35 % hydrogen peroxide.
Description
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
Time Frame
Patients will be evaluated during 21 days.
Title
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.
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Raissa Araujo de Mesquita
City
Belém
State/Province
PA
ZIP/Postal Code
66087680
Country
Brazil

12. IPD Sharing Statement

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

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