|
|
||||||||
|
J Am Dent Assoc, Vol 131, No 10, 1478-1484.
© 2000 American Dental Association |
ADVANCES IN DENTAL PRODUCTS |
| ABSTRACT |
|---|
|
|
|---|
Methods. The authors recruited 57 subjects with maxillary anterior teeth of shade A3 or darker (as gauged against a value-oriented shade guide). The subjects were 18 to 65 years of age and in good general and dental health. After matching the subjects by sex and age, the authors randomly assigned them to either a control group, which used a 10 percent CP whitening agent, or an experimental group, which used a 15 percent CP agent.
Results. The results indicated that there was no significant difference in shade change between the groups after one week of treatment (t = 1.455, P = .05), but there was a significant difference at the end of the treatment period (t = 2.303, P < .05), as well as two weeks after treatment concluded (t = 2.248, P < .05). There was no significant difference in sensitivity (t = 1.399, P > .05).
Conclusions. There was a significant difference in color change between the 10 percent CP and 15 percent CP groups at the end of the study period. There was no significant difference in level of tooth sensitivity between the two groups, and the incidence was equal; there was, however, a significant difference in variability of tooth sensitivity between the two groups.
Clinical Implications. If performed under the careful guidance of a dentist, at-home whitening is an effective treatment, regardless of whether 10 percent CP or 15 percent CP is used. There may be added color change and varying sensitivity with the use of 15 percent CP.
Tooth bleaching is not a new technique in dentistry; it was reported more than a century ago.14 In 1937, Ames5 reported a technique for treating mottled enamel that made use of a mixture of hydrogen peroxide, or HP, and ethyl ether on cotton, heated with a metal instrument, for 30 minutes per visit for five to 25 visits. Younger6 used this technique in 1942 in 40 children with dental fluorosis. This and similar techniques using concentrated HP and heat have been accepted treatment since the 1930s.7
In 1968, Dr. William Klusmeier, an orthodontist, described a technique using Gly-Oxide (Marion Merrell Dow Inc.), a 10 percent carbamide peroxide, or CP, oral antiseptic. He placed Gly-Oxide in the orthodontic positioners of some patients to improve their gingival health and noted that the treatment resulted in whitened teeth, as well as tissue improvement. In 1972, he switched to Proxigel (Reed and Carnrick Pharmaceutical Co.), which also contained 10 percent CP, in a laboratory-fabricated custom-fitted nightguard, because the viscosity of the Proxigel allowed it to stay in the tray.8
The first commercially available 10 percent CP product specifically for tooth bleaching was marketed by Omni International in 1989. The product had its roots in the findings of Dr. John Munro,9 a general dentist who used a 10 percent CP solution to control inflammation after root planing in a vacuum-formed plastic splint and noted an additional result of whitened teeth.
Haywood and Heymann10 published the first clinical study on tooth whitening using Proxigel in vacuum-formed custom trays. This is the technique known as "nightguard vital bleaching," a whitening method in common use today. Drs. Haywood and Heymann conducted laboratory and clinical investigations of this technique and reported the technique and their findings in the literature in 1989.10 In their technique, the nightguard is custom-fabricated to hold the whitening gel in contact with the enamel surface. The CP reacts with moisture to yield free peroxide radicals or nascent oxygen to change the color of enamel and dentin and produce a whitening effect.10 The dental profession rapidly recognized the benefits of an at-home bleaching treatment, and the technique has become a popular method of lightening teeth.11
According to a 1991 use survey, 78 percent of general practitioners performed tooth-whitening procedures, and 59 percent recommended the dentist-prescribed at-home method.12 In another survey that year, 9,846 dentists reported using at-home whitening techniques, and 79 percent of those recognized the techniques usefulness and overall clinical success.13 Ninety-one percent of 8,143 dentists responding to a 1995 survey stated that they had used vital tooth bleaching; 79 percent of the respondents reported success with the treatment, and 12 percent reported that they were not satisfied with it.14
Four types of peroxide-containing tooth-whitening materials are available15:
With the introduction of so many agents, several with different concentrations, dentists have many options when prescribing at-home whitening. Much research has shown the safety and efficacy of 10 percent CP.1621 However, it is not known if the more concentrated gelswhich contain 15 percent, 16 percent or 22 percent CPwill whiten teeth to a greater extent; no controlled clinical trials have been reported, only clinicians anecdotal reports and manufacturers claims. Only one published study has shown that higher concentrations of CP will whiten teeth more quickly; it was performed on extracted teeth using 16 percent CP.22 In addition, no in vivo studies have been published that establish whether increasing the concentration will increase the commonly reported side effect of transient tooth sensitivity.
We conducted a double-blind study with human subjects to evaluate the two formulations of the NUPRO Gold Tooth Whitening System (Dentsply Preventive Care) to determine whether the 15 percent CP formulation whitened teeth to a greater extent than the 10 percent CP formulation. We also assessed and compared tooth sensitivity experienced by subjects in the two groups to evaluate whether the higher CP concentration worsened this side effect.
We divided subjects into a 10 percent CP group (the control group) and a 15 percent CP group (the experimental group) through a matching process using two variables: age and sex. A paired list of names was supplied to the manufacturer, which then randomly assigned one member of each pair to the control group and the other to the experimental group. The control group received the NUPRO Gold gel with 10 percent CP (the only version of the NUPRO Gold system on the market when the study was conducted), and the experimental group received the gel with 15 percent CP.
The regimen we prescribed for all subjects followed the manufacturers recommendations. For each subject, we recorded a baseline Vita shade and made a color transparency (using Ektachrome 100 Professional Film [Eastman Kodak]) and an intraoral camera at a 1:1 magnification. We made a maxillary alginate impression and poured it in dental stone for fabrication of the custom bleaching tray, using the material and design recommended by the manufacturer. Each subject then underwent a professional prophylaxis.
Two weeks after this initial evaluation and prophylaxis, the tray and gel were delivered to each subject with instructions for use. All subjects were instructed to wear the agent for at least four hours and as long as overnight, according to the manufacturers instructions and depending on patient preference. We provided each patient with a daily diary, in which he or she recorded the amount of time the agent was applied. Patients also were instructed to record tooth hypersensitivity using a hash mark on a standardized grading scale ranging from 0 (no sensitivity) to 20 (severe sensitivity). We calculated the sensitivity scores by measuring length of the scale from 0 to the hash mark, and a statistician (E.R.) analyzed this information by using a matched-pairs t-test. Patients also were encouraged to write comments in the diary.
After baseline evaluation, patients were examined at the following intervals: after one week of gel use (the treatment periods midpoint), after completing the two weeks of gel use and two weeks after treatment ended. At each evaluation, calibrated clinicians used a Vita value-oriented shade guide to make shade measurements of the maxillary central and lateral incisors. (There are 16 shades in all.) They also made a color transparency with the baseline Vita shade tab in the photographic field. Diaries and extra gel were collected at the two-week posttreatment evaluation. Subjects followed a standardized oral hygiene regimen throughout the study.
Frequency distributions (by number and percentage) described shade changes for subjects in both groups. We used a matched-pairs t-test to compare average tooth sensitivity during the two weeks between the control and experimental groups. Homogeneity of variance was used to test for significant difference in variance for tooth sensitivity for 10 percent CP as compared with 15 percent CP.23 We also used matched-pairs t-tests to examine changes between the two groups from baseline to one week, baseline to two weeks and baseline to two weeks posttreatment. A probability level of .05 indicated significance.
Shade change.
Frequency distributions for the change in shade from baseline were calculated for three assessment points: after one week of use, after two weeks of use and two weeks posttreatment. After treatment, we found shade changes of four to 15 shades (as compared with a value-oriented shade guide) in both experimental and control groups.
After one week of treatment, 46 percent of the subjects in the experimental group showed a change of seven to nine shades, and 54 percent of the subjects in the control group showed a change of four to six shades.
At the conclusion of two weeks of treatment, 54 percent of the subjects in the experimental group showed a change of seven to nine shades, and 12 percent showed a change of 13 to 15 shades after two weeks of use, whereas 0 percent showed this change after one week of use. In the control group, 38 percent of subjects showed a change of seven to nine shades, and 15 percent showed a change of 13 to 15 shades at the conclusion of treatment, whereas 0 percent showed this change after one week of treatment.
At two weeks posttreatment, 54 percent of the subjects in the experimental group and 38 percent of the subjects in the control group showed a change of seven to nine shades. Twelve percent of the subjects in the experimental group and 15 percent of the subjects in the control group showed a change of 13 to 15 shades. These results were the same as those we found at the conclusion of the two-week treatment period.
The average shade change for the 10 percent CP group after one week was a mean of 5.65 ± a standard deviation of 3.05 shades; for the 15 percent CP group, it was 6.69 ± 2.65 shades. The average shade change for the 10 percent CP group after two weeks of treatment was 7.69 ± 3.03 shades; for the 15 percent CP group, it was 9.42 ± 2.32 shades. The average shade change for the 10 percent CP group two weeks posttreatment was 7.73 ± 2.96 shades and for the 15 percent CP group, 9.38 ± 2.26 shades (Figures 1
The dental profession rapidly recognized the benefits of an at-home bleaching treatment, and the technique has become a popular method of lightening teeth.
![]()
MATERIALS AND METHODS
TOP
ABSTRACT
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
REFERENCES
Fifty-seven subjects with maxillary anterior teeth of shade A3 or darker as judged by comparison with a value-oriented Vita Lumin (Vita Zahnfabrik, Germany) shade guide were enrolled in a double-blind clinical trial conducted in the advanced general dentistry clinic at the University of Maryland Dental School. Subjects were 18 to 65 years of age, and all were in good general and dental health.
![]()
RESULTS
TOP
ABSTRACT
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
REFERENCES
Of the 56 subjects who began the study, 26 pairs of matched subjects (n = 52 individual subjects) completed the study. One subject, with chipped incisal edges of teeth nos. 8 and 9, withdrew from the study after application of the gel for two days owing to sensitivity. One patient was dropped from the study owing to noncompliance in use of the material. We did not include these two subjects or their matched subjects in our analysis of results.
and 2
). We found no significant difference in shade change from baseline between the two groups after one week of treatment (t = 1.455, P = .05, nonsignificant). At both the two-week (t = 2.303, P < .05, significant) and two-weeksposttreatment (t = 2.248, P < .05, significant) assessment points, the experimental group showed a larger amount of shade change than did the control group (Table 1
).
|
|
|
Sensitivity for the control group was 2.78 ± 2.44 (mean ± standard deviation) and for the experimental group was 4.19 ± 4.58 (Table 2
). We found a significant difference in tooth sensitivity variability associated with use of 10 percent CP vs. use of 15 percent CP (10 percent = 2.442 and 15 percent = 4.582, respectively). Incidence of tooth sensitivity was equal between the two groups. Two of the 26 subjects in each group did not experience any tooth sensitivity.
|
| DISCUSSION |
|---|
|
|
|---|
Statistically, there was no significant shade change between the two groups after one week of treatment. The experimental group showed a statistically larger amount of shade change than did the control group at both the two-week and the two-weeksposttreatment evaluations, as would be expected intuitively with higher concentrations of CP. In this study, the average shade change after two weeks and two weeks posttreatment in the group using the 15 percent concentration of CP was roughly 9.4 ± 2 shades; it was roughly 7.7 ± 3 shades for the group using 10 percent CP. It is interesting that the 15 percent CP gel did not whiten the teeth more quickly, as we originally had thought it would. In many cases, the difference was not noticeable until the full two-week regimen was completed.
References to transient tooth and gingival sensitivity have been reported with use of CP. Approximately two-thirds of patients undergoing treatment will experience one or both side effects.16 Our investigation compared the average degree of tooth sensitivity between the 10 percent CP and 15 percent CP groups. We found no significant difference between the two groups in the average degree of tooth sensitivity during the two weeks of treatment, and the incidence of sensitivity was the same in both groups. The 15 percent CP group showed more variability in tooth sensitivity than the 10 percent CP group, but all patients reported that the sensitivity ceased immediately after finishing the two-week active phase of treatment and that they had no lingering sensitivity.
Research indicates that 10 percent CP, as found in the NUPRO Gold Tooth Whitening System, is safe when administered properly under the supervision of a dentist.1621 Our study shows that both 10 percent CP and 15 percent CP gels are effective in whitening teeth. The 15 percent CP group, however, showed a larger amount of shade change during the course of this study with no significant increase in sensitivity, except in variability, than did the 10 percent CP group. It has been shown that lower concentrations of CP will achieve the same results as higher concentrations; it merely takes longer.23 Our study indicates that the higher concentrations do lighten teeth more significantly than do the lower concentrations over the recommended period of use. With no significant difference in average tooth sensitivity noted between the groups and with patients wanting results more quickly, it seems that the higher concentrations may be a better choice to meet patient demands.
Many manufacturers have addressed the issue of tooth sensitivity by incorporating fluoride or potassium nitrateor a combination of the twoto reduce sensitivity. Anecdotal data have indicated that these materials significantly reduce sensitivity. One study showed no significant difference in sensitivity between a group using an agent with potassium nitrate and a group using one without.24 Another study confirmed these results, showing no significant difference in sensitivity during use; however, patients using the potassium nitratecontaining gel appeared to return to baseline at a lower level of sensitivity.25 Further studies must be completed with both 10 percent CP and 15 percent CP whitening agents to determine the cause of tooth sensitivity and the best method of managing it, as well as differences in color stability of whitened teeth over a period of several years.
Our study indicates that the higher concentrations of carbamide peroxide do lighten teeth more significantly than do the lower concentrations over the recommended period of use.
| CONCLUSIONS |
|---|
|
|
|---|
At-home whitening is an effective treatment when it follows careful diagnosis and treatment planning, regardless of whether 10 percent CP or 15 percent CP is used. The practitioner must monitor the procedure carefully and communicate well with the patient to maximize the benefits, minimize the risks and, thereby, ensure success.
| FOOTNOTES |
|---|
| REFERENCES |
|---|
|
|
|---|
This article has been cited by other articles:
![]() |
L. Y. Tay, C. Kose, A. D. Loguercio, and A. Reis Assessing the Effect of a Desensitizing Agent Used Before In-office Tooth Bleaching J Am Dent Assoc, October 1, 2009; 140(10): 1245 - 1251. [Abstract] [Full Text] [PDF] |
||||
![]() |
S. S. Meireles, I. da Silva dos Santos, A. Della Bona, and F. F. Demarco A Double-Blind Randomized Controlled Clinical Trial of 10 Percent Versus 16 Percent Carbamide Peroxide Tooth-Bleaching Agents: One-Year Follow-up J Am Dent Assoc, September 1, 2009; 140(9): 1109 - 1117. [Abstract] [Full Text] [PDF] |
||||
![]() |
R. V. Armenio, F. Fitarelli, M. F. Armenio, F. F. Demarco, A. Reis, and A. D. Loguercio The Effect of Fluoride Gel Use on Bleaching Sensitivity: A Double-Blind Randomized Controlled Clinical Trial J Am Dent Assoc, May 1, 2008; 139(5): 592 - 597. [Abstract] [Full Text] [PDF] |
||||
![]() |
K. LUK, L. TAM, and M. HUBERT Effect of light energy on peroxide tooth bleaching J Am Dent Assoc, February 1, 2004; 135(2): 194 - 201. [Abstract] [Full Text] [PDF] |
||||
![]() |
R. T. BASTING, A. L. RODRIGUES JR., and M. C. SERRA The effects of seven carbamide peroxide bleaching agents on enamel microhardness over time J Am Dent Assoc, October 1, 2003; 134(10): 1335 - 1342. [Abstract] [Full Text] [PDF] |
||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |