Lee 2015.
Study characteristics | ||
Methods |
Study type: RCT (single‐blinded, 3 parallel groups) Duration of trial: 4 weeks (the first 2‐week treatment period, the strantium chloride (SC) toothpaste, the n‐CAP toothpaste, and the laser treatments were applied to each group. For the subsequent 2‐week maintenance period, all participants performed only toothbrushing with the same fluoride dentifrice) Duration of follow‐up: 4 weeks |
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Participants |
Setting: Department of Advanced General Dentistry at Yonsei University Dental Hospital, Seoul, South Korea Inclusion criteria: having at least 2 hypersensitive teeth that were scored > 4 according to the VAS and scored > 1 according to the air blast, and having exposed root surfaces from which a painful response was elicited by a dental probe and air blast Exclusion criteria: chronic disease; carious lesions on the selected or neighbouring teeth; any desensitizing therapy on the selected teeth during the last 2 months; cervical filling, non‐vital teeth, and cracks on the selected teeth; or pregnancy or side effects from a laser Total number: 102 participated in the experiment, however, 20 were excluded because they did not complete the follow‐up sessions. Therefore, a total of 82 participants were evaluated Age range: 20 to 65 years Sex (M/F): 29/53 |
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Interventions | Participants were randomly divided into 3 groups Group 1: positive control group, strantium chloride dentifrice (n = 30) Group 2: experimental group 1, 20% n‐CAP dentifrice (n = 30) Group 3: experimental group 2, Er,Cr:YSGG laser (n = 22) Details: the laser irradiation was divided into 3 phases according to the manufacturer's recommended settings. The first and second phases were supplied with water (0.25 W, 20 pulses per sec (pps), 16% water, 16% air), whereas the third phase was conducted without water and the laser treatment was implemented for 30 seconds in each phase |
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Outcomes | Responses to tactile stimulus was recorded as VAS and thermal (air blast) stimulus was recorded using the air sensitivity scale by Schiff et al: 0 = tooth/subject does not respond to air stimulus; 1 = tooth/subject responds to air stimulus but subject does not request discontinuation of stimulus; 2 = tooth/subject responds to air stimulus and subject requests discontinuation or moves from stimulus; 3 = tooth/subject responds to air stimulus, subject considers stimulus to be painful, and requests discontinuation of the stimulus; at baseline, 1 week, 2 weeks, and 1 month after intervention |
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Notes |
Baseline characteristics: all participants received supra‐ and subgingival scaling prior to entry into the study. All participants received the dentifrice tested in each group and used the same toothbrush with flat and soft bristles (Skydent No 32 SOFT, Skydent, Korea), and they were instructed to brush their teeth twice a day for 1 minute every time with the same toothbrushing method that they usually used Sample size calculation: not calculated; quote: "The small sample size was also another limitation. Therefore, further study is needed to evaluate the combined effects of the n‐CAP dentifrice and the Er,Cr:YSGG laser with sufficient samples based on a sample size estimation" Source of funding: National Research Foundation of Korea (NRF), funded by the Ministry of Education, Science and Technology Ethics approval: quote: "The research protocol was initially submitted for approval by the Ethics Committee of the Yonsei Dental Hospital, Seoul, Republic of Korea" Informed consent: quote: "Participants were fully informed about the purpose and procedures of this study, and voluntarily provided written informed consent" Adverse events: not reported in the study |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information provided |
Allocation concealment (selection bias) | Unclear risk | Insufficient information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Single‐blind study" Comment: the patients may be aware of the treatments received due to the differences in perception of each treatment. The outcome is likely to be influenced by incomplete blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Possible incomplete blinding of participants can lead to unclear detection bias when reporting pain level. Neither of the assessors participated in treatment procedure to maintain blindness |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "20 participants dropped out of the study (loss to follow‐up). These 20 were excluded from this experiment because they did not attend follow‐up appointments" Comment: participants who did not complete the follow‐up sessions were excluded from the study. However, reasons for missing outcome data unlikely to be related to true outcome |
Selective reporting (reporting bias) | Low risk | All intended outcomes were reported in the study |
Other bias | Low risk | No other sources of bias were identified Sample size calculation was not mentioned in the study |