Gerschman 1994.
Study characteristics | ||
Methods |
Study type: RCT (2 parallel groups) Duration of trial: not mentioned in the study Duration of follow‐up: 8 weeks |
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Participants |
Setting: Oro‐Facial Pain Clinic, University of Melbourne, Australia Inclusion criteria: age 15 to 69 years; even distribution of males and females; mobility of teeth < 1; VAS ≥ 3 Exclusion criteria: active periodontal disease; periodontal surgery within the last 6 months; teeth with carious lesions; large restorations; pulpitis and cracked enamel; chronic, debilitating disease or chronic disease with daily episodes of pain, for example, arthritis; daily doses of medication, for example, analgesics, anticonvulsants, antihistamines, sedatives, tranquillizers, mood‐altering drugs, or anti‐inflammatory drugs; participation in a desensitizing dentifrice study within the last 3 months Total number: 71 participants enrolled and completed Age range: 15 to 69 years (mean age: 37.5 years) Sex (M/F): not mentioned in the study |
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Interventions | Participants were randomly divided into 2 groups
Group 1: placebo group (28 participants enrolled and completed). Details not mentioned in the study Group 2: GaAlAs laser (active group). Details: (1) GaA1As (P‐laser, RHR Marketing Services Ltd, Bentlcigh, Victoria) was used for active treatment. An identical, unpowered placebo laser was also used. The P‐laser system has a power output of 30 mW; and a red aiming beam, with a power output of approximately 0.1 mW. (2) The laser source has a GaAlAs‐diode and a wavelength of 830 nm. (3) The stated power of 30 mW (± 10%) is the precise measure of energy emitted. The diode specification is 50 mW. A linear scale power meter with LCD read‐out designed to measure only light sources at a wavelength of 830 nm was employed. (4) LLLT was applied for 1 minute to both the apex and cervical area of the tooth. Calculation for total irradiance was based on mean power (watts) per time (seconds), for example, 30 mW for 60 s = 1.8 J. The power meter was used to calibrate the laser before each use. LLLT was reapplied at 1 week, 2‐week, and 8‐week intervals and dentinal hypersensitivity was rated on the VAS at the conclusion of each visit Subgroup 2a: tactile sensitivity group (22 participants enrolled and completed) Subgroup 2b: thermal sensitivity group (21 participants enrolled and completed) |
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Outcomes | Responses to air blast stimuli and tactile stimuli (VAS) at baseline, and 1 week, 2 weeks, 8 weeks after intervention | |
Notes |
Baseline characteristics: 1. baseline hypersensitivity assessment included thermal sensitivity (response to a 1‐second air blast from a dental air unit syringe at a temperature of 18 to 21 ℃) and tactile sensitivity (response to passing a dental explorer over the labial cervical area); 2. the subjects rated their response on a continuous 100 mm VAS. Only 1 tooth per subject was tested. No specific tooth type (that is, incisor, premolar, molar) was selected. A VAS >= 3 was required for inclusion in the study; 3. care was taken so that 1 stimulus did not interfere with the succeeding stimuli, that is, tactile first then thermal. Subjects were instructed to brush their teeth with a non‐desensitizing dentifrice twice daily throughout the study Sample size calculation: not mentioned in the study Source of funding: not mentioned in the study Ethics approval: not mentioned in the study Informed consent: quote: "subjects were drawn mainly from a private practice population and on referral by other dentists and were required to sign an informed consent form" Adverse events: 2 patients reported a temporary, reversible pain sensation in response to lasing |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Subjects experiencing thermal and tactile sensitivity were assigned randomly to an active or placebo group by means of a computer‐generated randomized code" |
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 | Unclear risk | Insufficient information provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No descriptions on loss to follow‐up |
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, source of funding and ethics approval were not mentioned in the study |