Efectiveness of a Brief Protocol by a Low (6%) Concentration Gel Peroxide Hydrogen of Teeth Bleaching

NCT02603354 | Completed DMC

• 1 other identifier: 15/001a
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study was to evaluate, the effectiveness and sensitivity post-treatment of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated bleaching agent, the impact of shorter interval times on tooth sensitivity and to compare the efficacy with 2 different application protocols. This is a clinical randomized double-blind split-mouth study. 31 patients were treated with: one upper hemi arcade with one application of 36 minutes and the other hemi arcade with 3 applications of 12 minutes each with a 6% hydrogen peroxide. Two sessions were appointed with 48h of intervals between them. Tooth colour was registered by VITA Classical amd VITA Bleach guide by two blinded assessors in the beginning, immediately after each session. Tooth colour variation and sensitivity were compared between both application protocols

Conditions

Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

• Efectiveness by color difference ( using the spectrophotometer Vita Easy Shade)

  The shade was determined using the obtained parameters L\*, a\*, and b\* by Spectrophotometer . The color alteration after each session was given by the differences between the values obtained at the session and the baseline (∆E). ∆E was calculated using the following formula: ΔE = \[(ΔL\*)2 + (Δa\*)2 + (Δb\*)2\]1/2 .

  1 month

Study Arms (2)

3x12 m peroxide gel tooth bleaching 6%

ACTIVE COMPARATOR

bleaching with 6% hydrogen peroxide 3 times of 12 minutes session for in office bleaching teeth

Drug: peroxide gel tooth bleaching 6%

1-36 m peroxide gel tooth bleaching 6%

EXPERIMENTAL

bleaching with 6% hydrogen peroxide 1 time of 36 minutes session for in office bleaching teeth

Drug: peroxide gel tooth bleaching 6%

Interventions

peroxide gel tooth bleaching 6% DRUG

gel of hygrogen peroxide for teeth bleaching in a low concentration (6%)

Also known as: bleaching gel

1-36 m peroxide gel tooth bleaching 6%; 3x12 m peroxide gel tooth bleaching 6%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients with Anterior teeth without restorations, previous bleaching procedures, cervical lesions, or dental pain

You may not qualify if:

• Pregnant or lactating,
• Had moderate or severe fluorosis,
• Tetracycline stains,
• Orthodontic treatment,
• Periodontal disease,
• Orofacial tumors,
• Trauma,
• Tooth malformation,
• Were taking analgesic, anti-inflammatory, or antibiotic drugs

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Eduardo Fernandez

Santiago, N/A = Not Applicable, 7500505, Chile

Location

Related Publications (1)

• Martin J, Vildosola P, Bersezio C, Herrera A, Bortolatto J, Saad JR, Oliveira OB Jr, Fernandez E. Effectiveness of 6% hydrogen peroxide concentration for tooth bleaching-A double-blind, randomized clinical trial. J Dent. 2015 Aug;43(8):965-72. doi: 10.1016/j.jdent.2015.05.011. Epub 2015 Jun 6.

  PMID: 26057085 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Eduardo Fernandez, PhD

  University of Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Eduardo Fernández

Study Record Dates

• First Submitted: November 8, 2015
• First Posted: November 11, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

CL (1)