Efficacy of a 6% Hydrogen Peroxide Tooth Bleaching Agent

NCT03217994 | Completed DMC

• 1 other identifier: 15/001b
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The present study investigates whether it is possible to achieve equally satisfactory results between 37.5% hydrogen peroxide gel and 6% gel for teeth bleaching. A prospective, double-blind, randomized clinical trial was carried out. A total of 33 patients were selected from the clinic of the Faculty of Dentistry at the University of Chile. The patients included men and women over 18 years old without prior tooth whitening treatments, tooth decay, or restorations of the upper front teeth. The patients had tooth colors of A3 or less according to the Vita Classical scale, which was determined with a Vita Easy® Shade spectrophotometer. The study was carried out with a "split-mouth" design. One side of each mouth was randomly treated with 37.5% hydrogen peroxide, and the other side was bleached with 6% hydrogen peroxide. Each group received 3 to 12 minutes of treatment with the respective gel applications. Two sessions of bleaching were carried out each week. Color was assessed at 7 different sessions for 3 months. The spectrophotometer was used to measure the total variation of color (ΔE) between the baseline (session 1) and different measurement times (sessions 2-7). We compared ΔE for both agents using the Mann-Whitney test.

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)

37.5% gel

ACTIVE COMPARATOR

37.5% gel to bleach teeth

Drug: gel HP

6% gel

EXPERIMENTAL

6% gel to bleach teeth

Drug: gel HP

Interventions

gel HP DRUG

gel of hygrogen peroxide for teeth bleaching

37.5% gel; 6% gel

Eligibility Criteria

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

You may qualify if:

• Age over 18 years (both sexes)
• present upper front teeth
• No caries
• No restorations (anterosuperior group)
• No previous whitening treatments
• Tooth color value of A3 or less (Vita Classical scale), which was determined with a spectrophotometer (Vita Easy Shade® Compact) on the middle third of the vestibular surface of the maxillary lateral incisors

You may not qualify if:

• Pregnant or nursing mothers
• In pharmacological treatment
• Bruxism and patients who reported prior tooth sensitivity
• Previous tooth whitening (either at home or professionally)
• Visible dental cracks, developmental defects or teeth stained by tetracycline or fluorosis in the anterosuperior group
• Treatment with fixed appliances
• Periodontal disease or cancer

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Eduardo Fernandez

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

Location

Related Publications (1)

• Estay J, Angel P, Bersezio C, Tonetto M, Jorquera G, Pena M, Fernandez E. The change of teeth color, whiteness variations and its psychosocial and self-perception effects when using low vs. high concentration bleaching gels: a one-year follow-up. BMC Oral Health. 2020 Sep 11;20(1):255. doi: 10.1186/s12903-020-01244-x.

  PMID: 32917192 DERIVED

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Javier Martín

  University of Chile

  PRINCIPAL INVESTIGATOR

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: Profesor

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: January 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

CL (1)