Lu 2000.
Study characteristics | ||
Methods | Study design: randomised, parallel‐group (8 arms), controlled trial Location: University of Pennsylvania, Einstein College of Medicine, Bronx, New York (university hospital), USA Number of centres: 1 Recruitment period: not reported Funding source: not reported |
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Participants | Inclusion criteria: patients with severe gag reflex requiring any dental treatment (Impression, restoration, scaling/curettage to prophylaxis paste) Exclusion criteria: not reported Age: 17 to 76 years old Gender: not reported Number randomised: not reported Number evaluated: 230 |
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Interventions | Type of intervention:
Control: placebo Dosage: for sedation: any of the following:
Total number of intervention groups: 3 groups (with 3 subgroups for Group 2 and 4 for Group 3 respectively):
Duration of treatment:
Duration of follow‐up: no follow‐up |
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Outcomes | Completion of dental procedure: reported Completion of dental procedure as assessed by researcher/dentist*: reported as excellent, good, fair, poor:
* Completion of procedure: excellent, good and fair / Procedure incomplete: poor Reduction in gagging assessed by participant: reported as excellent, good, fair, poor*:
* Reduction in gagging: excellent, good and fair / No reduction: poor Health‐related quality of life: not reported Adverse effects: not reported |
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Notes | Sample size calculation: not reported Key conclusions of the study authors: "The P6 point has remarkable anti‐gagging effects if stimulation is applied correctly. Clinicians may apply thumb pressure at the P6 point to achieve some effect, although this is not as effective as acupuncture. Nevertheless, a substantial percentage of gagging patients would be able to go through dental procedures without gagging when the P6 point is stimulated" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described. Quote: "The patients were randomised into three groups" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Low risk | All outcomes described were reported. Conclusions are in accordance with the results |
Other bias | Low risk | None |