Sample and ethical approval
This study was a randomized and prospective double-blind clinical trial with one year of follow-up. The design is shown in Figure 1 and follows the CONSORT (Consolidated Standards of Reporting Trials) recommendations and the principles of the Helsinki Convention. The study was approved by the local Committee of Ethics approval number (15/001) and registered in ClinicalTrials.gov (NCT03217994).
Selection of the Sample
Thirty-five patients were recruited from the Faculty of Dentistry of the University of Chile. These patients had asked for a whitening treatment and volunteered to participate in the study by signing an informed consent form approved by the Ethics Committee of the Faculty of Dentistry.
All of these patients met the following inclusion criteria:
- Age 18 or older (both sexes).
- At least six upper healthy frontal teeth, with no restorations or crowns in these teeth.
- A color A3 or less (using the Vita classical scale) as determined using a spectrophotometer (Vita Easy Shade® Compact, Vita Zahnfabrik) in the middle third on the buccal surface of central incisors.
The following exclusion criteria were used:
- Pregnancy or lactation.
- Bruxism or tooth sensitivity.
- Teeth with prior whitening treatment (either at home or in-office).
- Teeth with visible dental cracks, developmental defects, or tetracycline or fluorosis discoloration.
- Presence of non-carious cervical lesions
- Nonvital discolored teeth.
Study Design
Patients who were evaluated and were excluded due to having any pathology that prevented them from entering the study (such as caries, periodontal disease, or tooth sensitivity) were referred to the dental clinic of the Faculty of Dentistry at the local University for proper treatment.
The sample size was determined following similar studies [18] with a significance level of 5% and a statistical power (1-β) of 0.90. As a result, it was estimated a minimum of 32 patients.
Since it was expected a 5% dropout; the initial number of participants was 35 individuals. Treatments were carried out in the clinic of the Faculty of Dentistry; the researchers monitored the participants.
The study used a split-mouth randomized design with a 37.5% hydrogen peroxide (Polaoffice + 37.5% ,SDI,Victoria,Australia) (Ph=7.0) [5, 6] and a 6% hydrogen peroxide (Polaoffice + 6% ,SDI,Victoria,Australia) (Ph=8.0) as whitening agents. Both products were used in each participant, applying the 6% to one hemi-arcade (canine, central, and lateral incisors) and the 37.5% to the other. The whitening systems were assigned using SPSS 21 software (SPSS, IBM, New York, USA). To blind the operators, each product was properly masked with coded labels. Auto-mix syringes of Polaoffice + in the office teeth whitening system were used (SDI Limited). The syringes contained hydrogen peroxide in concentration of 37.5% or 6% in the form of a thixotropic gel with similar features of color and viscosity.
Different operators than those who performed the whitening procedure conducted all color measurements in both upper central incisors. The follow-up was performed similarly.
Preliminary phase
The color of each upper central incisor was measured with a Color scales (Vita classical Guide and Vita Bleached guide, Vita Zahnfabrik) and objectively with spectrophotometer (Vita Easy Shade® Compact, Vita Zahnfabrik) that was previously calibrated according to the manufacturer instructions. To standardize this evaluation, a silicone matrix was made (Zetaplus, Zhermack, Rovigo, Italy) with a 6mm-diameter window on the buccal surface that allowed the positioning of the tip of the spectrophotometer on the middle third of the labial surface of the teeth.
Intervention: Whitening Protocol
Each participant had two whitening sessions separated by an interval of one week. At the beginning of each session, dental prophylaxis was performed using a dental brush and stone pumice with water at low speed. A plastic lip retractor and a gingival barrier (Gingival barrier; SDI Limited, Victoria, Australia) were used to protect the soft tissues. Whitening gels were applied evenly to each hemi-arcade on their vestibular surface.
The Protocol included three applications of the whitening gel for twelve minutes (36 minutes each session), to standardize the protocol between both gels. Between each application, the gel was removed with rolls of cotton moistened with water and then the teeth were dried carefully. At the end of the third application, the gel was removed using copious amounts of water, and the gingival barrier and lip retractor were removed. The patients received indications and were scheduled to the next visit.
Controls
At the end of the first session, tooth color was measured subjectively (Color scales) and objectively with a spectrophotometer (Vita Easy Shade® Compact, Vita Zahnfabrik)[19]. The measurements were repeated after a week, a month, six months and a year after whitening.
Color evaluation
Subjective extraction and treatment data
The color was assessed visually under standardized light conditions (same place, time, natural light source, all assessments were performed between 10:00 AM and 3:00 PM) by two previously calibrated operators, who showed a previous agreement (Visual Scales) of at least 85% as determined using weighted k-statistics. The viewing geometry, object-observer distance, visual angle, and background color were held constant. Each operator evaluated three times each tooth. If both operators coincided in their selection, the determined value remained as definitive, if there was a discrepancy, a calibrated third operator (professor of restorative dentistry) defined between both colors.
The Vita classical Guide (Vita Classic, Vita Zahnfabrik) and Bleached guide (Vita Bleached Guide, Vita Zahnfabrik) were used for subjective evaluation using the tab arrangement proposed by Ontiveros and Paravina [20]. The observers assessed the color of both central incisors at the start of the study, at each session of whitening, and one week, one month, six months and one-year post-treatment. The color was recorded on the middle third of the labial surface as established by the guidelines of the American Dental Association [21]. The difference in tooth color was calculated as the number of units that the tooth changed according to the shade guide arrangement (ΔSGU).
Objective treatment data
The color was measured objectively with the spectrophotometer, in the same way as described in the preliminary phase. Objective data were evaluated according to the three axes of the CIELAB system (L *, a * and b *). The ΔE was also calculated using the Pythagorean theorem as follows:
ΔE = [(ΔL) 2 + (Δa) 2 + (Δb) 2] 1/2
The variation on each parameter at different time points was calculated about the initial value (i.e., the measurement of color before the first session of whitening).
Also, the color difference was calculated by means of the CIEDE2000 formula proposed by Luo in 2001 [22] and Whiteness Index proposed by Gerlach in 2002 [23].
Self-perception and psychosocial impact assessment
Before whitening treatment, participants completed two questionnaires: the psychosocial impact dental aesthetic questionnaire (PIDAQ) and the oral health impact profile (OHIP-14). These questionnaires were repeated after a week, one, six and twelve months post whitening treatment. They were completed under the supervision of an examiner who was available to answer every question.
The PIDAQ is psychometric testing to measure the psychosocial consequences of dental aesthetics [24]. It consists of 23 items on a five-point Likert-type scale from 0 (total disagreement) and to 4 (complete agreement). A patient may receive a total score of 0 to 72 points. The evaluation is also divided into four subscales: one positive (dental confidence [six questions]) and three negative (psychological impact [eight questions], aesthetic concern [three questions], and social impact [six questions]). A more positive subscale score indicates greater confidence in itself, while higher scores on the negative subscales indicate the adverse effects of cosmetic dentistry.
The OHIP-14 is an assessment used to evaluate the aesthetic perception [25]. The survey is scored on a five-point Likert-type scale. Each option partners with a score: very often (4), often (3), from time to time (2), almost never (1), or never or not (0). A higher score indicates poor patient self-perception of the cosmetic dentistry. To calculate the score of OHIP-14 for each patient, we added the total score of 14 questions to generate a total score between 0 and 56 points.
Statistical Analysis
The data were tabulated, and their normal distribution was analyzed using the Shapiro-Wilk test. The Mann-Whitney test was used to compare the efficiency of the results between groups, whereas, for comparisons between two assessment times and to assess color rebound in each group the Wilcoxon and T-Student tests were used.
PIDAQ and OHIP-14 test scores were determined, and the results for each time point were compared using the Wilcoxon test. Data were statistically analyzed using SPSS 21.0 (Lead Technologies INc., Charlotte, NC, USA). The data were considered statistically significant when p < 0.05.