Yilmaz 2011b.
| Study characteristics | ||
| Methods |
Study type: RCT (split‐mouth, 2 groups) Duration of trial: between January and September 2009 Duration of follow‐up: 3 months |
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| Participants |
Setting: Department of Periodontology, Near East University, Turkey Inclusion criteria: at least 1 or more (maximum 4) contra‐lateral pairs of hypersensitive teeth Exclusion criteria: carious lesions on the selected or neighboring teeth, restorations, active periodontal diseases and more than 3 mm gingival recession on the selected teeth, any professional desensitizing therapy during the last 6 months, use of desensitizing toothpaste in the last 3 months, having any systemic diseases, being under analgesics/anti‐inflammatory drugs at the time of the study, pregnancy and smoking Total number: 42 participants with 146 teeth enrolled and completed Age range: 18 to 64 years (author's reply) (mean age: 33.8 years) Sex (M/F): 18/24 |
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| Interventions |
Group 1: Er,Cr:YSGG laser (wavelength: 2780 nm; output: 0.25 W; duration: 30 s) Details: for each subject, selected teeth were randomly assigned to the test or the control group by the toss method, and then, half of the sensitive teeth were irradiated with Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA) on hard tissue mode with a mz6 sapphire tip using non‐contact mode at an energy level of 0.25 W and a repetition rate of 20 kHz, 0% water and 10% air. The treatment time was 30 s per surface by scanning the cervical part of the tooth Group 2: placebo laser Details: in the placebo group, the same Er,Cr:YSGG laser without laser emission was used (If any subjects had more than 1 pair, all teeth on the same side received the same treatment. All active and placebo treatments were performed only at the 1st visit, by the same clinician) |
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| Outcomes | Responses to air blast stimuli (VAS) at baseline, and immediately, 1 week, 1 month, 3 months after intervention | |
| Notes |
Baseline characteristics: 1. the vitality of all experimental teeth was examined at the beginning and end of the trial by an electric pulp tester (Digitest, Parkel, NY, USA). Each subject received a professional prophylaxis before study and was given oral hygiene instructions at 2 separate appointments during the 4‐week pre‐treatment period; 2. the degree of sensitivity to an evaporative stimulus was determined qualitatively by means of an air blast for 3 s at a distance of approximately 1 cm and at right angle to the buccal site of the assigned teeth, while adjacent teeth were isolated with cotton rolls to prevent false‐positive results. Air stimulus time was controlled by chronometer and the distance was measured by a periodontal probe (UNC‐15, Hu‐Friedy, Chicago, IL, USA). Patients were asked to record their overall sensitivity by marking a point on a 10 cm VAS, which was marked 'no pain' on the left end and 'unbearable pain' on the right end. All stimuli were given by 1 operator at the same dental chair with the same equipment yielding similar air pressure (55 to 60 psi) and temperature (21 to 22℃) each time. A calibration session was performed to determine intra‐examiner consistency. 7 subjects were included for this session and measurements were repeated within 30 minutes. Calibration for plaque index (PI) evaluation was performed with a periodontal probe (UNC‐15, Hu‐Friedy) by repeating measurements at mesial and distal half of the tooth surface adjacent to the gingival margin Sample size calculation: quote: "A minimum clinically significant difference in VAS scores of 0.6 was determined from available literature on DH. The power analysis was conducted based on this minimum clinically significant difference in VAS scores, using alpha at level 0.05, at 80% power and a σ of 1.16. On the basis of these data, the number of patient required to be enrolled to conduct this study has been calculated as 40" Funding source: the study was self‐funded by the authors and their institution Ethics approval: quote: "Study protocol and related consent forms were approved by the Institutional Review Board of Near East University (protocol ID#27.3.3.a)" Informed consent: quote: "Following verbal information about the treatment plan, possible discomforts and potential risks, the subjects who signed the informed consent form were included in the study" Adverse events: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "For each subject, selected teeth were randomly assigned to the test or the control group by the toss method" Comment: adequate |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Due to use of placebo laser, the study might be free of performance bias |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "DH was assessed with VAS and PI scores were recorded at four examination periods; immediately, at 1 week, 1 and 3 months after treatment by a single calibrated examiner who was not aware of the type of treatment applied" Comment: adequate |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | All intended outcomes were reported in the study |
| Other bias | Low risk | The study appears to be free of other bias |