Phase 4
N=108
Combined Bleaching Technique: Efficacy and Tooth Sensitivity
Tooth Bleaching · Tooth Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT03089216 ↗Enrolled (actual)
108
Serious AEs
71.3%
Results posted
Aug 2019
Primary outcome: Primary: Tooth Sensitivity (TS) — 1; 1; 1; 0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Combined Bleaching(2x20) (Procedure); Combined Bleaching(2x20) with arginine (Procedure); Combined Bleaching (1x20) (Procedure); Combined Bleaching(1x20) with arginine (Procedure); 8% arginine and calcium carbonate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terezinha de Jesus Esteves Barata
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tooth Sensitivity (TS) |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY Color Evaluation |
8.28; 8.18; 7.72; 8.11 | — |
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%).
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03089216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.