García 2017.
Study characteristics | ||
Methods |
Study type: RCT (split‐mouth design) Duration of trial: not mentioned in the study Duration of follow‐up: 2 months |
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Participants |
Setting: Periodontal Pathology and Surgery Unit belonging to the Oral Surgery and Implantology Master Degree program of the University of Barcelona and a private clinic of the same area, Spain Inclusion criteria: patients diagnosed with dentine hypersensitivity in at least 2 teeth at different quadrants Exclusion criteria: any desensitizing treatment (current or last month); pregnancy; eating disorders (bulimia, etc.) or diet that cause erosion and/or tooth wear; orthodontic treatment; teeth whitening in the past 3 months; teeth with large fillings or reconstructions affecting the assessment area; teeth with fractures, cracks or untreated caries; non‐vital teeth or pulpal pathology; parafunction Total number: 30 patients (120 teeth) Age range: 19 to 67 years Sex (M/F): 9/21 |
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Interventions |
Group 1: (30 patients, n = 60 teeth): control group (placebo). Treatment of 2 teeth was simulated without activating the laser Group 2: (30 patients, n = 60 teeth): laser THOR LX2 (THOR Photomedicine Ltd, Chesham, UK) at a 5 mm distance, with oscillating movements, wavelength 660 nm, power 200 mW, continuous mode, illuminated treatment area 1.15 cm2, irradiance 173 mW/cm2, irradiation time 60 s, energy 12 Joules, fluence 10.4 J/cm2 |
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Outcomes | Dentine hypersensitivity for tactile stimulation (touching the tooth neck with a sharp dental probe) and thermal stimulation (with an air jet from the syringe dental chair, isolating adjacent teeth with cotton rolls) was recorded before the laser treatment, immediate post‐treatment (after 2 minutes), 2 weeks, 1 month, and 2 months after treatment (VAS from 0 to 100) | |
Notes |
Baseline characteristics: patients were treated with scaling and root planing and subsequently referred if diagnosed with dentine hypersensitivity Sample size calculation: not mentioned in the study. Following the baseline examination, each side was randomly allocated either to the treatment or the control side with a series of random numbers Source of funding: the authors state no conflict of interest Ethics approval: quote: "The institutional review board (Ethical Committee of Clinical Investigation, University of Barcelona Dental School) reviewed and approved the study protocol" Informed consent: quote: "All patients were informed of the nature and objectives of the study, and signed consent prior to inclusion in the study" Adverse events: quote: "There were no adverse effects of diode laser treatment and no complications" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Following the baseline examination, each side was randomly allocated either to the treatment or the control side with a series of random numbers" |
Allocation concealment (selection bias) | Unclear risk | Insufficient information provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants is likely adequate due to use of placebo laser |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcome measurement is likely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data from the result table during 2‐month follow‐up period |
Selective reporting (reporting bias) | Low risk | The study did not report included standard deviations for the estimated marginal means of VAS for tactile and thermal stimulation (Table 1) |
Other bias | Low risk | No other sources of bias were identified Sample size calculation not mentioned in the study |