Tevatia 2017.
Study characteristics | ||
Methods |
Study type: parallel, RCT Duration of trial: not mentioned in the study Duration of follow‐up: 6 weeks |
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Participants |
Setting: not clearly described in the study. Authors' institution is Department of Periodontology and Oral Implantology, ITS Centre for Dental Studies and Research, Muradnagar, Ghaziabad, Uttar Pradesh, India Inclusion criteria: absence of undergoing desensitizing therapy, absence of gestation or lactation, non‐allergic to the medicament employed in the study, do not have systemic conditions causing or predisposing to dentine hypersensitivity (e.g., chronic acid regurgitation), do not have excessive dietary or environmental exposure to the acids, absence of any teeth or supportive structures with any other painful pathological defects, and have baseline pain of above 5.0 VAS score Exclusion criteria: not mentioned in the study Total number: 120 participants. Quote: "Any drop‐outs were excluded from the study. Each patient included in the study was present at every follow‐up period" Age range: 18 to 55 years (mean 36.5 years) Sex (M/F): 69/51 |
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Interventions | Patients were randomly divided into 4 groups (n = 30 per group) Group 1: 5% potassium nitrate (KNO3) Details: 5% KNO was applied for 60 s on the tooth surface. In each visit of a patient, KNO3 was applied using a new disposable brush. Further, patients were restrained to rinse the teeth until 3 minutes Group 2: GaAlA diode laser Details: lased by GaAlA laser Photon Plus, Zolar Co., 980 nm with 62.2 J/cm2 energy in non‐contact mode, power wattage 0.5 W and using a fiber of 320 μ diameter. Each site underwent 3 applications of 60 s Group 3: 5% KNO and diode laser Details: the KNO3 gel was left on the tooth surface for 60 s before laser treatment Group 4: placebo (control) Details: commercial toothpaste was applied (placebo‐control) for 60 s |
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Outcomes | Responses to tactile (explorer), air blast and cold water using VAS scores were measured at the baseline, immediate postoperative application, 2, 4, and 6 weeks | |
Notes |
Baseline characteristics: 1. scaling and root planning were performed before the sensitivity treatment to all the patients. In addition, teeth vitality was assessed. The vitality was checked using an electric Pulp Tester. All selected teeth were vital, which was the inclusion criteria. Oral hygiene instructions were provided to the patients and asked to perform tooth brushing twice daily (toothpaste was standardized after confirming the absence of any sensitivity check agents and handed over to the patients with strict instructions), employing modified bass technique; 2. there was negligible difference in VAS scores between the groups at baseline Sample size calculation: not mentioned in the study Source of funding: none. Quote: "There are no conflicts of interest" Ethics approval: quote: "The research protocol was reviewed and approved by the Ethical Committee of the Institution" Informed consent: quote: "All patients were educated about the study, and then, written consent was acquired before enrolment in the study" Adverse events: none. Quote: "In the recall period of study, no adverse effects for any subjective signs (like an allergic reaction, ulceration, or with objective signs such as redness of mucosa and staining of teeth) were observed" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information provided |
Allocation concealment (selection bias) | Low risk | Quote: “Envelopes containing identifications for treatment groups were enclosed, mixed, and then numbered” |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information provided. Possible incomplete blinding of participants can lead to unclear detection bias when reporting pain level Quote: “For all the follow‐ups, the same examiner was assigned every time” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Any drop‐outs were excluded from the study. Each patient included in the study was present at every follow‐up period" Comment: all participants completed the study |
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 was not mentioned in the study |