The Journal of the American Dental Association
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J Am Dent Assoc, Vol 139, No 5, 592-597.
© 2008 American Dental Association

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RESEARCH

JADA Continuing Education

The Effect of Fluoride Gel Use on Bleaching Sensitivity

A Double-Blind Randomized Controlled Clinical Trial



Ricardo V. Armênio, DDS, MS, Francisco Fitarelli, DDS, Mersita F. Armênio, DDS, MS, Flavio F. Demarco, DDS, PhD, Alessandra Reis, DDS, PhD and Alessandro D. Loguercio, DDS, MS, PhD


   ABSTRACT
 TOP
 ABSTRACT
 METHODS AND MATERIALS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Background. Fluoride has been recognized as a desensitizer; however, no study has addressed its effects to decrease tooth sensitivity when compared with a placebo in a double-blind randomized clinical study.

Methods. The authors divided 30 participants into two groups: one that received a placebo and another that was treated with fluoride. All patients used 16 percent carbamide peroxide (CP) in a custom-fitted tray until their teeth achieved shade A1 or lighter. After daily removal of CP, the patients wore a tray containing either sodium fluoride or placebo for four minutes. The authors statistically analyzed the perception of the intensity of tooth sensitivity and the weekly shade changes for both groups, as well as the intensity of tooth sensitivity ({alpha} = .05).

Results and Conclusions. The use of fluoride gel did not affect the whitening efficacy of the CP. The authors observed no difference between the groups receiving the placebo and the fluoride treatment in terms of tooth sensitivity experience (P > .05); however, patients who received the placebo had a higher-intensity tooth sensitivity than that of patients who received the fluoride (P < .001).

Clinical implications. The use of 1.23 percent sodium fluoride after each bleaching regimen does not affect the bleaching efficacy of CP. Also, the use of sodium fluoride gel reduces the intensity of tooth sensitivity.

Key Words: Fluoride; bleaching; carbamide peroxide; tooth sensitivity; randomized clinical trial

Abbreviations: CP: Carbamide peroxide. • {Delta}SGU: Change in number of shade guide units. • SGUs: Shade guide units.

The ultimate objective of esthetics in dentistry is to create a beautiful smile, with teeth of pleasing inherent proportions and arrangement to one another. Another important feature that contributes to a pleasing appearance of teeth is color. A 1996 survey involving 3,215 subjects from the United Kingdom reported that 50 percent of the population perceived they had some kind of tooth discoloration,1 which indicated that patients commonly were dissatisfied with the color of their teeth. This finding helps to explain why the popularity of tooth bleaching has increased during the last few decades.

Dentists have used carbamide peroxide (CP) as the main bleaching agent since 1989,2 partially because of its ability to deliver a stable form of hydrogen peroxide, the active bleaching agent. Initially, dentists used a 10 percent concentration; however, since manufacturers have introduced numerous CP-based home bleaching products, dentists may select from bleaching agents with varied concentrations of the active CP, ranging from 5 to 22 percent.

The successful outcomes of these varying in-home dental bleaching agents have been documented extensively in the literature. Gels that are more concentrated can whiten teeth faster than those that have lower concentrations.35 However, the gels that have lower concentrations can provide the same effect as those with higher concentrations when the dentist extends the treatment time.3

Although the use of higher concentrations can shorten the treatment time,35 it may induce in the patient an increased level of sensitivity4,68 that clinicians cannot predict easily. Earlier studies9,10 attempted to identify predictors of sensitivity; however, only inherent patient sensitivity (a history of sensitive teeth) and having more than one application per day had any correlation. Age, sex, exposed dentin or cementum, cracks, pulp size, allergies and decay were not predictable indicators of sensitivity.9,10

Dentists have used several approaches to reduce tooth sensitivity. Reduction in wearing time and frequency of application, temporary interruption of whitening and use of an active ingredient such as potassium nitrate are methods commonly used by clinicians.10,11 Dentists also have used fluoride as an active agent to reduce sensitivity1217; however, they usually apply fluoride only after the patient experiences tooth sensitivity.17,18 To the extent of our knowledge, no study has been published addressing the sensitivity-preventive effect of fluoride when used concomitantly with a daily bleaching regimen. Therefore, the aim of our double-blind randomized controlled clinical study was to evaluate whether the use of 1.23 percent sodium fluoride in the tray after each daily bleaching regimen would decrease tooth sensitivity when compared with a placebo.


   METHODS AND MATERIALS
 TOP
 ABSTRACT
 METHODS AND MATERIALS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
The institutional review board of University of West of Santa Catarina, Joaçaba, Santa Catarina, Brazil, reviewed and approved the study protocol.

We enrolled 30 undergraduate students from the University of West of Santa Catarina who had anterior teeth with a shade of A3.5 or darker as judged by comparison with a value-oriented shade guide (Vita Lumin, Vita Zahnfabrik, Bad Säckingen, Germany) in a double-blind controlled clinical trial. All subjects received a dental screening and a dental prophylaxis two weeks before the start of bleaching and signed an informed consent form before the study began.

Inclusion and exclusion criteria. Patients included in this clinical trial were at least 18 years old and had good general and oral health. We required that participants have six caries-free maxillary anterior teeth without restorations on the labial surfaces, be willing to sign a consent form and have central incisors determined to be shade A3.5 or darker. We excluded patients from the study if they had undergone tooth-whitening procedures, had labial anterior restorations, were pregnant or lactating women, had tooth sensitivity, had severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), had bruxism habits or had any gross pathology in the mouth.

Study design. We divided subjects randomly into the experimental or the placebo group by means of a coin toss. Neither the patient nor the evaluator knew to which group the patient was assigned. We made an alginate impression of each subject’s maxillary and mandibular arch and filled them with dental stone. To produce study models, we did not apply block-out material to the labial surfaces of teeth. We used a 0.9-millimeter soft vinyl material, provided by the manufacturer, to fabricate the custom-fitted tray for the whitening gel. We trimmed the excess of labial and lingual surfaces 1 mm from the gingival junction.

We delivered the tray and 16 percent CP gel (FGM Dental Products,Whiteness HP, Joinville, Santa Catarina, Brazil) to each subject with oral instructions for use. We instructed all subjects to wear the agent for at least four hours at night. In the morning, we instructed them to remove the tray, wash it and brush their teeth as usual. The patients used the custom-fitted tray until their teeth became shade A1 or B1 as judged by the researchers during recall visits.

After each daily bleaching regimen, we instructed patients to wear the custom-fitted tray containing either a placebo or a 1.23 percent sodium fluoride gel (FGM Dental Products) for four minutes. The placebo gel had the same composition as the sodium fluoride gel, except that it did not contain the active fluoride ingredient. We gave the desensitizing agent or the placebo to each subject in unmarked syringes. The syringes contained only numbered codes that neither the evaluators nor the patient could identify.

Shade evaluation. The shade guide’s 16 tabs are arranged from highest (B1) to lowest (C4) value. Although this scale is not linear in the truest sense, we treated the changes as representing a continuous and approximately linear ranking for the purpose of analysis. We calculated shade changes from the start of the active phase to the individual recall times by calculating the change in the number of shade guide units ({Delta} SGUs) that occurred toward the lighter end of the value-oriented list of shade tabs.

Two evaluators (A.D.L. and A.R.), using calibrated methods, recorded the shade of each subject’s teeth at baseline and weekly. The measurement area of interest for shade matching was the middle one-third of the facial surface of the anterior (central incisors), according to American Dental Association guidelines. Five patients whom we did not include in the sample because they participated in the pilot study participated in the training phase of this study. The two examiners scheduled these patients for bleaching and evaluated their teeth against the shade guide weekly. We required that the two examiners, before beginning the study evaluation, agree on shade by at least 85 percent ({kappa} statistic).

Tooth sensitivity evaluation. We asked subjects to record daily whether they experienced sensitivity according to the following criteria: 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe.19 We averaged these values for statistical purposes and arranged them into three categories: overall percentage of patients with tooth sensitivity, incidence of tooth sensitivity (number of weeks experiencing tooth sensitivity) and overall tooth sensitivity intensity.

Statistical analysis. We checked the agreement between examiners by using the {kappa} statistic. We calculated means and standard deviations for {Delta} SGU at each weekly recall visit for each group. We subjected the data to a two-way repeated measures analysis of variance (groups versus time), with time as the repeated factor. After that, we used a post hoc analysis (Tukey test, {alpha} = .05) to make pairwise comparisons.

We compared the different percentages of patients with tooth sensitivity between groups by using the Fisher exact test ({alpha} = .05). We compared the incidence of tooth sensitivity (number of weeks) using the {chi}2 test ({alpha} = .05) and we analyzed the intensity of the tooth sensitivity using the Student t test for independent samples ({alpha} = .05).


   RESULTS
 TOP
 ABSTRACT
 METHODS AND MATERIALS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Of the 30 participants who began the study, 29 were evaluated and completed the study. One participant decided to drop out of the bleaching treatment, so we excluded this patient from the study. The {kappa} statistic agreement between the two evaluators was 89 percent.

The mean (± standard deviation) color of the teeth in SGUs before the beginning of the treatment was 12.4 ± 0.90 for the group receiving the placebo and 12.5 ± 0.84 for the group treated with fluoride. The mean (± standard deviation) time needed to complete the placebo treatment was 5.4 ± 1.3 weeks (minimum three weeks and maximum seven weeks), whereas the group treated with fluoride required 5.2 ± 1.6 weeks (minimum three weeks and maximum seven weeks) to complete the treatment. Table 1Go depicts the means and standard deviations of the {Delta} SGUs after each assessment.


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TABLE 1 Change in tooth shade between assessment points for the two treatment groups.

 
The statistical analyses revealed that the interaction of groups versus time was not statistically significant (P = .85). We observed no significant difference between the treatment groups regarding bleaching efficacy (P = .53). Only the main effect of time was significant (P = .001). The mean bleaching score after one and two weeks was significantly different in relation to that after the other weeks (P = .001). After two weeks of bleaching, the participants exhibited a change of five to seven SGUs.

Twenty-five of 29 patients (86.2 percent) experienced some sensitivity in this study (Table 2Go). The difference in percentages of tooth sensitivity for patients in the placebo group (14 of 15, 93.3 percent) and for patients in the fluoride-treated group (11 of 14, 78.6 percent) was not statistically significant (P = .27). We observed a similar finding for the incidence of sensitivity (Table 3Go). We observed no significant difference between the two groups (P = .21).


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TABLE 2 Comparison of number of patients who experienced tooth sensitivity during the bleaching regimen.

 

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TABLE 3 Comparison of the incidence of tooth sensitivity (total number of weeks) during the bleaching regimen.

 
We observed a significant difference, however, in terms of the intensity of tooth sensitivity (P = .001). For the group receiving the placebo, the intensity of the tooth sensitivity was significantly higher (score of 2.4 ± 1.2) than that observed in patients receiving the fluoride treatment (score of 1.7 ± 0.8) (Table 4Go).


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TABLE 4 Intensity of tooth sensitivity during the bleaching regimen.

 

   DISCUSSION
 TOP
 ABSTRACT
 METHODS AND MATERIALS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
The results of our investigation corroborate those of previous studies demonstrating that whitening of vital teeth by using CP is an effective procedure.4,5,20

Although we observed no significant difference in the rate of bleaching between the two groups, we observed that for both groups, the overall number of {Delta} SGUs after two weeks of treatment was lower than that observed in other clinical trials that involved concentrated gels. Although the average change in color in our study was approximately 6.0 SGUs, Kihn and colleagues4 reported a change of 9.4 SGUs after two weeks when patients used a 15 percent CP gel.

Several investigators7,21,22 reported a change of six to seven SGUs after two weeks when 10 percent CP gels were used. One might suppose that the use of the desensitizing agent in our study could have delayed the bleaching; however, if this was true, the bleaching in the group receiving the placebo would have been more effective than that in the group treated with fluoride, which was not the case. Investigators should conduct future studies to elucidate this matter. Another possible explanation is that although participants reported that they regularly used the peroxide gel throughout the study, they actually may not have done so, thus creating the delay in the bleaching process.

Investigators9,23 recognize tooth sensitivity as the most common side effect of bleaching, because as many as two-thirds of people who undergo tooth bleaching are affected by tooth sensitivity sometime during the period of active bleaching. The etiology is complex. One study reported that tray insertion alone contributed to some sensitivity11; however, several authors24,25 have attributed tooth sensitivity to the permeation of the bleaching agent into the pulp.

Although tooth sensitivity typically is mild,26 causing only an occasional annoyance to the patient, some patients may exhibit such severe sensitivity that they choose not to complete the treatment. Under such circumstances, the patient will require consultation with the dentist. As mentioned earlier, dentists have used several approaches to reduce patients’ tooth sensitivity during the bleaching regimen, such as reducing the frequency and duration of gel application.10,11 Other investigators18,27 have reported the use of fluoride or potassium nitrate, which are believed to produce some pain relief in cases of tooth sensitivity.18

Our rationale for the daily use of fluoride gel delivered in the bleaching tray was to prevent the manifestation of tooth sensitivity, thus avoiding one of the most common adverse effects of bleaching. However, our study demonstrated that using such a protocol did not eliminate or reduce the patients’ experience of tooth sensitivity, since the percentage of patients who experienced tooth sensitivity throughout the study period, as well as the incidence of sensitivity during certain weeks, was similar for both the fluoride and the placebo groups.

On the other hand, our study showed that the daily use of fluoride reduced the intensity of tooth sensitivity during the bleaching regimen. We found similar reports in the literature.18,27 For instance, Haywood and colleagues18 reported that using potassium nitrate-fluoride gel applied in the bleaching tray in patients with tooth sensitivity reduced the sensitivity in the majority of the patients and produced some degree of pain relief. However, it is worth mentioning that the aforementioned study did not include a placebo group. Another study27 showed that the use of an active 3 percent potassium nitrate and 0.11 percent fluoride desensitizing agent for 30 minutes prior to whitening decreased tooth sensitivity in comparison with a placebo.

Some studies have attributed the beneficial effect of fluoride to the precipitation of calcium fluoride crystals (approximately 0.05 micrometers) in dentin, thus reducing the functional radius of the dentinal tubules.12,28,29 Theoretically, this precipitation can reduce the penetration of hydrogen peroxide into the pulp by reducing the permeability of dentinal tubules, without affecting the oxidizing potential of the active bleaching agent.

From our data, we believe that the benefits of using such a protocol are not strong enough to convince clinicians to adopt its use in daily practice. This protocol could be advantageous when clinicians are performing bleaching in patients who have a history of sensitive teeth. In such cases, the concomitant use of fluoride can bring the patient’s tooth sensitivity to an acceptable level, thus facilitating the bleaching regimen.

Another important issue that future clinical trials should evaluate is the daily use of potassium nitrate instead of fluoride gel in the bleaching tray. Had we used potassium nitrate instead of fluoride, we may have observed different results. Potassium nitrate has an apparent analgesic or anesthetic effect on nerve fibers by not allowing them to repolarize after the initial depolarization in the pain signal.30,31 Perhaps this different desensitizing mechanism can help prevent or lessen tooth sensitivity during a bleaching protocol. However, future clinical trials should confirm this hypothesis.

Our study was limited by its small sample size, which can be attributed to the difficulties in the recruitment of patients for this controlled clinical trial. Thus, we call for similar studies with larger sample sizes to reach more conclusive statements about this subject.


   CONCLUSION
 TOP
 ABSTRACT
 METHODS AND MATERIALS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Within the limitations of our study, we conclude that although the use of sodium fluoride gel does not reduce the experience of tooth sensitivity, its use after each bleaching regimen reduces the overall intensity of tooth sensitivity.


   FOOTNOTES
 

Dr. Ricardo Armênio is an assistant professor, Dental Materials and Operative Dentistry, University of West of Santa Catarina, Joaçaba, Santa Catarina, Brazil.


At the time this research was conducted, Dr. Fitarelli was an undergraduate student, Dental Materials and Operative Dentistry, University of West of Santa Catarina, Joaçaba, Santa Catarina, Brazil. He now is in private practice in Joaçaba, Santa Catarina, Brazil.


Dr. Mersita Armênio is an assistant professor, Dental Materials and Operative Dentistry, University of West of Santa Catarina, Joaçaba, Santa Catarina, Brazil.


Dr. Demarco is an associate professor, Department of Operative Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.


Dr. Reis is an associate professor, Department of Restorative Dentistry, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brazil.


Dr. Loguercio is an associate professor, Department of Restorative Dentistry, Universidade Estadual de Ponta Grossa—Mestrado em Odontologia, Rua Carlos Cavalcanti, 4748, Bloco M, Sala 64A—Uvaranas, Ponta Grossa, Paraná, Brazil 84030-900, e-mail "aloguercio{at}hotmail.com". Address reprint requests to Dr. Loguercio.


Disclosures. None of the authors reported any disclosures.


   REFERENCES
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 ABSTRACT
 METHODS AND MATERIALS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 

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