Maximiano 2019.
| Study characteristics | ||
| Methods |
Study type: RCT (double‐blinded, 3 parallel groups) Duration of trial: not mentioned in the study Duration of follow‐up: 1 month |
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| Participants |
Setting: Dental School of the University of São Paulo, Brazil Inclusion criteria: patients in the age range 18 to 65 years, of both sexes, non‐carious cervical lesions and/or gingival recessions associated with dentine exposure and symptoms of cervical dentine hypersensitivity, and with at least 1 tooth with a minimum pain level of 4 cm on the VAS Exclusion criteria: pregnant patients or those in the breastfeeding stage, those who made continuous use of analgesic or anti‐inflammatory medications, those with active caries lesions or deficient restorations, those undergoing orthodontic treatment, and those with deficient oral hygiene or loss of dental structure that would need restorative treatment were excluded from the study, since these conditions could directly interfere in the results of evaluations Total number: 70 participants enrolled and completed Age range: 18 to 65 years Sex (M/F): not mentioned in the study |
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| Interventions |
Group 1: placebo laser (n = 23) Details: control/placebo patients received simulations of the 2 treatments. Prophylaxis with Nupro® paste was simulated with a rubber cup and water, taking care that the cup did not touch on the cervical region of the teeth in question, to prevent any possible change in the dentine structure, such as obliteration of tubules. Irradiation with Nd:YAG laser was simulated with the laser switched on, but with the display exhibiting 0 W and with the guide light only Group 2: CSP paste (NovaMin) (n = 23) Details: CSP patients received the treatment with 15% CSP prophylaxis paste (NUPRO Extra Care powered by NovaMin, Dentsply professional, lot 16050201), applied on the vestibular surface of the selected teeth, with a rubber cup at low speed for 60 s in accordance with the manufacturer’s instructions. Afterwards, the surfaces were washed with water and the patient performed a mouthrinse Group 3: Nd:YAG laser irradiation (n = 24) Details: laser patients received irradiation in the vestibular and cervical regions of the selected teeth, with Nd:YAG laser (Power Laser, Lares Research, San Clemente, CA, USA, process FAPESP 07/55497‐0). The equipment worked in a pulsed manner, with a pulse width of 150 μs and a fixed repetition rate of 10 Hz. Its energy system operated by means of a quartz fiber optic of 400 μm. Irradiation was performed with the fibre optic perpendicular to the tooth, in contact mode. 4 (4) irradiations were made with scanning movements: 2 in the mesio‐distal and 2 in the occlusal‐gingival directions. Each irradiation was made for up to 15 s, with an interval of 10 s between each irradiation, time necessary for thermal relaxation of dentine. The parameter used was 1 W of power, repetition rate of 10 Hz, 100 mJ of energy, and 85 J/cm2 of energy density |
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| Outcomes | Exposure Time to Air Blast and tactile stimuli (VAS) at baseline, 5 minutes, 1 week, and 4 weeks after the treatment | |
| Notes |
Baseline characteristics: an evaporative stimulus, with a jet of air applied in the cervical region of the tooth for 3 s at a distance of 1 mm with a pressure of 40 psi, and under relative isolation, covering the neighboring teeth with cotton wool rolls. Another measurement was made after tactile stimulation, with the exploratory probe in contact on the cervical region, passing over the mesial to the distal region and vice versa under constant pressure Sample size calculation: quote: "The sample calculation was based on comparison of the means, with an expected minimum difference of 2 units between the initial and final values of the VAS and standard deviation of 2. Considering an α of 5% and power of 80%, 26 patients per group would be required" Source of funding: State of São Paulo Research Foundation Ethics approval: quote: "Research Ethics Committee of the Dental School of the University of São Paulo ‐ CEP FOUSP (Report No. 2291636)" Informed consent: quote: "Patients that met all of the inclusion criteria signed consent forms before entering the trial" Adverse events: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed by a researcher not involved in the study, using the Excel program of the Microsoft Office package. Stratified randomization was performed, considering two strata: moderate (4–6.9 cm) and severe (7–10 cm) pain" |
| Allocation concealment (selection bias) | Low risk | Quote: "Allocation concealment was implemented with sequentially numbered opaque sealed envelopes. Each envelope was only opened by the researcher at the time of performing the treatment. The patients and evaluators did not know what the designated allocation was. The researcher did not know the patients’ level of pain" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Use of placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blinded study, the stimuli and pain measurements were made by 2 previously calibrated evaluators |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis was performed |
| 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 |