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The Effect of Desensitizing Agents in In-home or In-office Dental Bleaching

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Dental bleaching
Desensitizing therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring dental bleaching, dentin sensitivity, biomaterials

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients male or females, aged between 18 and 40 years.
  2. Smokers and nonsmokers.
  3. Patients with good general health.
  4. Patients with good oral health (no changes in hard or soft tissues).
  5. Have a minimum of 24 permanent teeth present and no restorations on anterior teeth.

Exclusion Criteria:

  1. Patients with a medical history marked by chronic use of analgesics, anti-inflammatory and psychotropic drugs.
  2. Patients with braces or prostheses or restorations on anterior teeth.
  3. Patients with periodontal disease or poor oral hygiene.
  4. Patients with prior tooth sensitivity or have made use of desensitizing agents in the last three months.
  5. Patients who are pregnant or nursing.
  6. Patients with eating disorders or dieting too acidic.
  7. Systemic conditions that predispose to tooth sensitivity.

Sites / Locations

  • University of Sao Paulo -Ribeirao Preto Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Desensitizing therapy

Dental Bleaching

Arm Description

14 groups (7 treated with in-office dental bleaching and 7 treated with home-use dental bleaching) . There will be 7 different types of dessensitizing agents that will be used together with the dental bleaching treatment

2 groups of dental bleaching treatment - 16% carbamide peroxide and 35% peroxide

Outcomes

Primary Outcome Measures

Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)

Secondary Outcome Measures

Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)

Full Information

First Posted
September 21, 2011
Last Updated
December 9, 2014
Sponsor
University of Sao Paulo
Collaborators
Universidade Federal de Sao Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT02316080
Brief Title
The Effect of Desensitizing Agents in In-home or In-office Dental Bleaching
Official Title
Evaluating Remineralizers and Desensitizers Agents in Dental Bleaching Treatment: in Vitro and in Vivo Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Universidade Federal de Sao Carlos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching agents, carbamide peroxide 16% (T1) and hydrogen peroxide 35% (T2) together with desensitizers/remineralizer agents, Sensodyne® dentifrice (D1); experimental dentifrice with 7,5% of Biosilicate micro-particles (D2); Odontis RX® dentifrice (D3); Sorriso® dentifrice (D4); Biosilicate micro-particles paste, 1:1 (D5), Desensebilize Nano P (D6), bioglass type 45S5 paste, 1:1 (D7); GC= distilled water, in the experimental groups: T1/D1; T1/D2; T1/D3; T1/D4; T1/D5; T1/D6; T1/D7; T1/GC e T2/D1; T2/D2; T2/D3; T2/D4; T2/D5; T2/D6; T2/D7; T2/GC. In the in vitro study, microhardness and roughness measurements, and images using scanning electron microscopy (SEM) will be made on samples of bovine dental enamel and dentin (4x4x3mm; n=10 per group) before and after the treatment with the bleaching gels (T1= 14 days/ 04 hours/day; T2=single session) and the desensitizers/remineralizer agents. In the clinical study, the volunteers (n=10 per group) will be evaluated regarding dentin hypersensitivity (DH), using visual analogue scale, before the beginning of the treatments (T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days) in which the desensitizers/remineralizer agents (there´s no control group in the clinical experiments) will be applying. Data will be analysed intra and inter-group, statistically.
Detailed Description
Background. Tooth sensitivity (TS) is a common side effect of tooth bleaching. The authors conducted a study to evaluate the efficiency of experimental desensitizing agents in reducing TS caused by bleaching agents. Methods. To test experimental desensitizing agents in TS caused by dental bleaching the authors selected 113 participants without TS and randomly treated them with T1-16% carbamide peroxide (14 days) or T2-35% hydrogen peroxide (single session). The period of the study was 14 days. Participants (in T1 and T2) used domestic-use (DU) or in office (IO) desensitizers (D): Control Group; (DU)- experimental dentifrice with 7,5% of Biosilicate micro-particles-(D1); Sensodyne® dentifrice-(D2); (DU)-Odontis RX Sensiblock® dentifrice-(D3); (IO)-Biosilicate micro-particles paste, 1:1-(D4); (IO)-bioglass type 45S5 paste, 1:1 (D6); (IO)-Desensebilize Nano P-(D6). On days 1, 3, 7, 10 and 14, the authors received the participants to apply IO desensitizers and to record TS with Visual Analogue Scale (VAS). Data was analyzed with two-way ANOVA (considering time and desensitizing as factors) and post-hoc Bonferroni test (α=0.05). Results. The use of experimental desensitizing agents G2 and G5 did not cause significantly difference in TS comparing to baseline. TS was not significantly different when G2 was used after 16% carbamide peroxide and G5 after 35% hydrogen peroxide application. Self-perception TS values were significantly (p<0.001) higher than recorded VAS. Conclusions. Experimental desensitizing agents containing Biosilicate® can prevent TS caused by bleaching agents: in dentifrice form when associated to 16% carbamide peroxide and in paste, when 35% hydrogen peroxide is used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
dental bleaching, dentin sensitivity, biomaterials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desensitizing therapy
Arm Type
Experimental
Arm Description
14 groups (7 treated with in-office dental bleaching and 7 treated with home-use dental bleaching) . There will be 7 different types of dessensitizing agents that will be used together with the dental bleaching treatment
Arm Title
Dental Bleaching
Arm Type
Experimental
Arm Description
2 groups of dental bleaching treatment - 16% carbamide peroxide and 35% peroxide
Intervention Type
Other
Intervention Name(s)
Dental bleaching
Other Intervention Name(s)
Whitness Perfect®, Whitness HP®
Intervention Description
Home-use or in-office dental bleaching was performed in patients that received different types od desensitizing therapy
Intervention Type
Other
Intervention Name(s)
Desensitizing therapy
Other Intervention Name(s)
Dentifrice of Biosilicate, Sensodyne® dentifrice, Odontis RX Sensiblock, Biosilicate micro-particles paste, 1:1, Bioglass type 45S5 paste, 1:1, Desensebilize Nano P
Intervention Description
Participants (in T1 and T2) used domestic-use (DU) or in office (IO) desensitizers (D): Control Group; (DU)- experimental dentifrice with 7,5% of Biosilicate micro-particles-(D1); Sensodyne® dentifrice-(D2); (DU)-Odontis RX Sensiblock® dentifrice-(D3); (IO)-Biosilicate micro-particles paste, 1:1-(D4); (IO)-bioglass type 45S5 paste, 1:1 (D6); (IO)-Desensebilize Nano P-(D6).
Primary Outcome Measure Information:
Title
Dentin hypersensitivity
Description
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Dentin hypersensitivity
Description
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Time Frame
Day 1
Title
Dentin hypersensitivity
Description
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Time Frame
Day 3
Title
Dentin hypersensitivity
Description
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Time Frame
Day 7
Title
Dentin hypersensitivity
Description
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Time Frame
Day 10
Title
Dentin hypersensitivity
Description
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients male or females, aged between 18 and 40 years. Smokers and nonsmokers. Patients with good general health. Patients with good oral health (no changes in hard or soft tissues). Have a minimum of 24 permanent teeth present and no restorations on anterior teeth. Exclusion Criteria: Patients with a medical history marked by chronic use of analgesics, anti-inflammatory and psychotropic drugs. Patients with braces or prostheses or restorations on anterior teeth. Patients with periodontal disease or poor oral hygiene. Patients with prior tooth sensitivity or have made use of desensitizing agents in the last three months. Patients who are pregnant or nursing. Patients with eating disorders or dieting too acidic. Systemic conditions that predispose to tooth sensitivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila Tirapelli, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo -Ribeirao Preto Campus
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040904
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.forp.usp.br/
Description
Dental School of Ribeirao Preto website

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The Effect of Desensitizing Agents in In-home or In-office Dental Bleaching

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