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

NCT02316080 | Completed Phase 4 DMC

• 1 other identifier: Fapesp 2010120326
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Hypersensitivity

Keywords

dental bleaching; dentin sensitivity; biomaterials

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline

Secondary Outcomes (5)

• Dentin hypersensitivity

  Day 1

• Dentin hypersensitivity

  Day 3

• Dentin hypersensitivity

  Day 7

• Dentin hypersensitivity

  Day 10

• Dentin hypersensitivity

  Day 14

Study Arms (2)

Desensitizing therapy

EXPERIMENTAL

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

Other: Dental bleaching

Dental Bleaching

EXPERIMENTAL

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

Other: Desensitizing therapy

Interventions

Dental bleaching OTHER

Home-use or in-office dental bleaching was performed in patients that received different types od desensitizing therapy

Also known as: Whitness Perfect®, Whitness HP®

Desensitizing therapy

Desensitizing therapy OTHER

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).

Also known as: Dentifrice of Biosilicate, Sensodyne® dentifrice, Odontis RX Sensiblock, Biosilicate micro-particles paste, 1:1, Bioglass type 45S5 paste, 1:1, Desensebilize Nano P

Dental Bleaching

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Universidade Federal de Sao Carlos: collaborator

Study Sites (1)

University of Sao Paulo -Ribeirao Preto Campus

Ribeirão Preto, São Paulo, 14040904, Brazil

Location

Related Links

• Dental School of Ribeirao Preto website

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

tooth-bleaching agent, Opalescence

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Camila Tirapelli, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: December 12, 2014
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

BR (1)