Combined Bleaching Technique: Efficacy and Tooth Sensitivity
1 other identifier
interventional
108
0 countries
N/A
Brief Summary
The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2016
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2016
CompletedFirst Submitted
Initial submission to the registry
March 17, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
August 5, 2019
CompletedAugust 5, 2019
June 1, 2019
8 months
March 17, 2017
May 1, 2018
June 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Tooth Sensitivity (TS)
Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" (minimum value) and 10 referred to "severe pain" (maximum value)). Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median.
during bleaching, and up to 48 hours postbleaching
Secondary Outcomes (1)
Color Evaluation
The evaluations were performed in the baseline period and one month after the treatment
Study Arms (4)
Combined Bleaching(2x20)
EXPERIMENTALIn-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide
Combined Bleaching(2x20) with arginine
EXPERIMENTALCombined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
Combined Bleaching(1x20)
EXPERIMENTALIn-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide
Combined Bleaching(1x20) with arginine
EXPERIMENTALCombined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
Interventions
one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
using during all the treatment.
Eligibility Criteria
You may qualify if:
- Upper and lower anterior teeth without restorations;
- Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).
You may not qualify if:
- Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
- Presence of non-carious lesions, such as abfraction, erosion and abrasion;
- Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
- Use of fixed orthodontic appliances;
- Presence of tooth sensitivity classified as equal to or greater than mild;
- Presence of severe dental dimming;
- Presence of parafunctional habits;
- Presence of any oral pathology;
- Smokers;
- pregnant and lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Terezinha de Jesus Esteves Barata
- Organization
- Federal University of Goias
Study Officials
- PRINCIPAL INVESTIGATOR
Isabella N Favarão, DDS, MS
Universidade Federal de Goias
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- tde Jesus Esteves Barata
Study Record Dates
First Submitted
March 17, 2017
First Posted
March 24, 2017
Study Start
April 1, 2016
Primary Completion
November 30, 2016
Study Completion
December 31, 2018
Last Updated
August 5, 2019
Results First Posted
August 5, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share