Safety and Efficacy of a 6% Hydrogen Peroxide Tooth Bleaching Agent

NCT02353611 | Completed DMC

• 1 other identifier: PRI-ODO 15/001
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bleaching protocol In each session, volunteers received prophylaxis with pumice powder and water. Then, gingival tissue was protected using a light-cured resin gum barrier applied according to the manufacturer's instructions (Lase Protect - DMC, São Carlos, SP, Brazil). Both bleaching agents were prepared by mixing hydrogen peroxide and thickening compounds according to the manufacturer's instructions (with 3 peroxide drops for 1 drop of thickener). The resultant gels were distributed uniformly on the upper hemiarcade surfaces of the teeth. A total of 8 teeth between the first premolars were bleached for each patient. In each bleaching session, the bleaching gels were applied twice for 12 minutes each. In each application, the surface of the gel was light activated with continuous irradiance for 12 minutes using LED/laser light with a total power of 1800 mW (Whitening Lase Plus - DMC Equipamentos, São Carlos, SP, Brazil). Three bleaching sessions were completed for the patients, and the interval between sessions was 7 days

Conditions

Tooth Bleaching

Keywords

tooth; bleaching

Outcome Measures

Primary Outcomes (1)

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

  Shade will be determined using L\*, a\*, and b\* parameters measured by Spectrophotometer at 1 and 9 month after bleaching. The color change (ΔE) will be determined by the differences between the values obtained at each checkpoint and the baseline measures using the formula: ΔE = \[(ΔL\*)2 + (Δa\*)2 + (Δb\*)2\]1/2

  1 month and 9 month

Study Arms (2)

6% bleaching agent

EXPERIMENTAL

One upper hemiarch will be bleached with 6% hydrogen peroxide with titanium oxide nanoparticles, activated by a led/laser hybrid light. Whitening compound will be mixed according to manufacturer's instructions and distributed uniformly over the buccal surface of the teeth of one upper hemiarch. In each bleaching session the gel will be applied twice for 12 minutes each and activated with continuous irradiance using the LED/laser light (Whitening Lase Plus-DMC Equipamentos, São Carlos, SP, Brazil). Three bleaching sessions will be completed with an interval of 7 days between them.

Other: 6% hydrogen peroxide

35% bleaching agent

ACTIVE COMPARATOR

Together with the experimental agent application, the other upper hemiarch will be bleached with 35% hydrogen peroxide whitening compound. The compound will be mixed according to manufacturer's instructions and distributed uniformly over the buccal surface of the teeth of the corresponding hemiarch. The gel will be applied twice for 12 minutes each and irradiated using the LED/laser light (Whitening Lase Plus-DMC Equipamentos, São Carlos, SP, Brazil). Three bleaching sessions will be completed with an interval of 7 days between them.

Other: 35% hydrogen peroxide

Interventions

6% hydrogen peroxide OTHER

Also known as: 6% bleaching gel

6% bleaching agent

35% hydrogen peroxide OTHER

conventional peroxide whitening compound acted like control

Also known as: 35%

35% bleaching agent

Eligibility Criteria

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

You may qualify if:

• 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, or tooth malformation, or
• were taking analgesic, anti-inflammatory, or antibiotic drugs

Sponsors & Collaborators

• University of Chile: lead

Related Publications (4)

• Bortolatto JF, Pretel H, Floros MC, Luizzi AC, Dantas AA, Fernandez E, Moncada G, de Oliveira OB Jr. Low Concentration H(2)O(2)/TiO_N in Office Bleaching: A Randomized Clinical Trial. J Dent Res. 2014 Jul;93(7 Suppl):66S-71S. doi: 10.1177/0022034514537466. Epub 2014 May 27.

  PMID: 24868014 BACKGROUND

• Martin J, Fernandez E, Bahamondes V, Werner A, Elphick K, Oliveira OB Jr, Moncada G. Dentin hypersensitivity after teeth bleaching with in-office systems. Randomized clinical trial. Am J Dent. 2013 Feb;26(1):10-4.

  PMID: 23724543 BACKGROUND

• Moncada G, Sepulveda D, Elphick K, Contente M, Estay J, Bahamondes V, Fernandez E, Oliveira OB, Martin J. Effects of light activation, agent concentration, and tooth thickness on dental sensitivity after bleaching. Oper Dent. 2013 Sep-Oct;38(5):467-76. doi: 10.2341/12-335-C. Epub 2013 Feb 7.

  PMID: 23391030 BACKGROUND

• Bersezio C, Martin J, Angel P, Bottner J, Godoy I, Avalos F, Fernandez E. Teeth whitening with 6% hydrogen peroxide and its impact on quality of life: 2 years of follow-up. Odontology. 2019 Jan;107(1):118-125. doi: 10.1007/s10266-018-0372-3. Epub 2018 Jun 30.

  PMID: 29961213 DERIVED

MeSH Terms

Interventions

Hydrogen Peroxide

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals

Study Officials

• Javier Martín

  University of Chile

  PRINCIPAL INVESTIGATOR

• Eduardo Fernandez

  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.Javier Martín

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 3, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 22, 2017

Record last verified: 2017-11