Flecha 2013.
Study characteristics | ||
Methods |
Study type: RCT (double‐blinded, split‐mouth design) Duration of trial: 12 months Duration of follow‐up: 6 months |
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Participants |
Setting: periodontology clinic of the Department of Dentistry of the Federal University of Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil Inclusion criteria: participants had good general and oral health, complained of pain in teeth located in different hemi‐arches of the mouth, manifested pain or discomfort in response to stimulus caused by the jet of air from a triple syringe, and initially responded to this stimulus with a score > 5 in the numeric rating scale Exclusion criteria: patients who had undergone previous professional desensitizing treatment or had used over‐the‐counter desensitizing products; those with chronic use of anti‐inflammatory, analgesic, or psychotropic drugs; pregnant and breastfeeding females; patients presenting allergies and idiosyncratic responses to product ingredients; eating disorders; systemic conditions that are etiologic factors or predisposing for DH, excessive dietary or environmental exposure to acids; and patients who underwent periodontal surgery or orthodontic treatment in the preceding 3 months. In addition, the following teeth were excluded: teeth or periodontium with pathology or defects likely to cause pain; those that were restored in the preceding 3 months; those that served as abutment for fixed or removable prostheses; those that were crowned or had extensive restorations; and those with restorations extending into the test area (cervical) Total number: 62 participants with 434 teeth Age range: 12 to 60 years Sex (M/F): 15/47 |
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Interventions |
Group 1: (62 patients, n = 216 teeth): GaAlAs laser (120 mW, 2.88 J/cm2, 795 nm, area: 0.031 cm2). Laser irradiation was performed for 3 sessions, at intervals of 48 hours Group 2: (62 patients, n = 218 teeth): cyanoacrylate group. 3 applications, at intervals of 48 hours, following the laser protocol |
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Outcomes | Sensitivity to thermal (air) stimulus was recorded before and on days 1, 3, 5, and 7 after the treatment (VAS score) | |
Notes |
Baseline characteristics: thorough scaling and root planing were performed as part of phase 1 therapy, and patients were advised to use 0.2% chlorhexidine mouthrinses for 2 weeks. Patients were recalled after 4 weeks. Persistent pockets of 5 mm at minimum of 2 sites in each quadrant were scheduled for flap surgery. The surgical procedure was performed by an experienced examiner Sample size calculation: detailed mention of the calculation Source of funding: no competing financial interests reported Ethics approval: quote: "The study protocol was approved by both the Research Ethics Committee of the UFVJM (no. 061/06) and Research Ethics Committee of the Federal University of Sao Paulo (no. 0530/08). The study was also conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000" Informed consent: quote: "Participants were informed about the research and signed the statement of free and informed consent" Adverse events: not mentioned in the study |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "An independent researcher (PG), who was masked to the patients and interventions, conducted randomization using opaque envelopes that had been prepared previously and sealed" |
Allocation concealment (selection bias) | Low risk | Quotes: "An independent researcher (PG), who was masked to the patients and interventions, conducted randomization using opaque envelopes that had been prepared previously and sealed" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The researchers who applied the treatments were only informed of the treatment to be performed when it was time to do so [blinding of personnel]. Masking was done by replacing the laser goggles with sleeping masks for each patient and simulating the application of the other treatment [blinding of participants]" Comment: blinding of personnel was inadequate. Blinding of participants was probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Interventions were always performed by the same researcher who did not participate in treatment evaluations" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "A single tooth (treated with laser) presented acute sensitivity, spontaneous pain, had to be covered with glass ionomer cement, and was excluded from statistical analysis" |
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 The authors report no conflicts of interest related to this study |