Impact of not removing bubbles generated during in-office bleaching in adult patients: Single-blind, split-mouth, randomized clinical trial
- Conditions
- Dentin SensivityM01.060.116
- Registration Number
- RBR-4nkyrct
- Lead Sponsor
- Elder Jossué Romero López
- Brief Summary
Hydrogen peroxide in high concentrations is the most commonly used substance for in-office whitening, it is a reactive species that releases products such as oxygen and hydroxyl. Manufacturers and some studies report that during this procedure, when the gel comes into contact, bubbles are formed at the interface between the bleaching gel and the tooth, and most of them mention that it is necessary to break these bubbles, justifying that this may interfere with treatment success.Therefore, this project conducted a randomized split-mouth clinical trial with the objective of evaluating whether the presence of the bleb can influence the efficacy, as well as the intensity and the absolute risk of the sensitivity of inoffice tooth whitening. The participants were divided into two groups, according to the rupture or not of the gel bubbles: Group 1: maintenance of the bubbles and Group 2: rupture of the bubbles. The protocol was performed in two sessions, with the application of a 35% hydrogen peroxide (PH) gel (Total Blanc Office, DFL, Rio de Janeiro, Brazil) on teeth 15 to 25, with a 7-day interval, whitening for 45 minutes each session. The color change was verified with the help of two color scales and a spectrophotometer, at the beginning of the study (baseline), after one week and before the second whitening session and 30 days after the end of treatment. The presence and intensity of tooth sensitivity was recorded through a sensitivity diary answered by the patient, within 48 hours after each whitening session by two scales: a visual analog scale (VAS) and a numerical rating scale (NRS). The evaluation of the whitening effectiveness in each group will be performed by the paired Wilcoxon test. The absolute risk of tooth sensitivity was compared by Fisher's exact test (p = 0.05) of the total percentage of participants (absolute risk) who experienced sensitivity at least once. The intensity of this variable, will be evaluated by Mann Whitney paired test (p = 0.05). No statistical difference was detected in terms of the efficacy and risk to sensitivity and intensity of sensitivity between the groups after 30 days of treatment. Approximately 93% of the participants experienced tooth sensitivity, which was mainly recorded as mild. There was no statistically significant difference between the two groups in the subjective assessments of color, and in the objective assessment the delta E showed no difference between the two groups. The maintenance of the bubble in the 35% hydrogen peroxide gel on the buccal surface did not affect the whitening efficacy and tooth sensitivity
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Age from 18 years old; regardless of sex; have good general and dental health conditions; upper teeth free of cavities and upper front teeth free of restorations on the buccal surface; in addition to central incisors showing C2 or darker color; evaluated in comparison with a visual color scale guided by the value of the teeth
Pregnant or breastfeeding women; users of fixed orthodontic appliances; with pre-existing previous restorations; presence of severe intrinsic stains on the teeth; participants with a previous history of tooth sensitivity or any associated pathology
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method