Lepore 2011.
| Methods |
Trial design: parallel (2 arms) Location: Columbia University Medical Center, USA Number of centres: 1 Study duration: recruitment and follow‐up dates not reported. Participants followed‐up at 2 months |
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| Participants |
Participants: 69 paediatric‐child patients between ages 1 and 6 years Inclusion criteria: not reported Exclusion criteria: not reported Age (years): between ages 1 and 6 years, with the majority (90%) being 2 years to 5 years (mean age of 3 years) Gender: not reported Number randomised: 69 (intervention group: 37; control group: 32) Number evaluated: 69 (intervention group: 37; control group: 32) |
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| Interventions |
Intervention: dental prophylaxis and topical fluoride application, routine oral health instructions (as given to the control group). In addition a personalized oral health action plan which consisted of an assessment of the patient's current caries risk and a list of suggestions on how to improve that status. The parent and dentist together chose 1 particular suggestion they felt was achievable Control: dental prophylaxis and topical fluoride application, routine, verbally dispensed oral hygiene and diet instructions targeting the specific needs of the patient Prophylaxis provided: both groups received a dental prophylaxis and topical fluoride varnish application Member of dental team delivering intervention: dentist Frequency of intervention: intervention group: 1 initial visit with OHA; control group: 1 initial visit with OHA Intensity of intervention (length of time): intervention group: not reported; control group: not reported Setting: secondary care Disease level: caries risk |
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| Outcomes | Data collected included DMFS, gingival health and plaque scores. During the first visit, the parents were questioned regarding the oral hygiene and diet behaviour of the child in order to fulfil the 6 survey topics (frequency of toothbrushing with a fluoridated dentifrice, parent‐assisted toothbrushing, bottle use, sippy cup use, frequency of juice consumption and frequency of between‐meal snacking). Data for the reported behaviour was categorized as low, moderate or high caries risk and assigned a numerical value of 0, 1 or 2, respectively | |
| Notes |
Funding: not reported Sample size calculation: not reported Adverse effects: not reported Declarations/conflicts of interest: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "divided randomly into control and intervention groups" Comment: insufficient information on random sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information on allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quotes: "32 patients in the control group received routine, verbally dispensed oral hygiene and diet instructions targeting the specific needs of the patient. In addition to the routine oral health instructions given to the control group, the 37 patients in the intervention group received a personalized oral health action plan" and "The parent and dentist together chose 1 particular suggestion they felt was achievable" Comment: blinding of participants was not possible; it is unclear the influence this would have on the risk of bias for this domain |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quotes: "Finally, since this was a single blind study, upon follow‐up examination, experimenter bias has to be considered and results may be skewed" and "...This discrepancy could probably be accounted for considering the other 3 major limitations of this study: the sample size, observation time and potential examiner bias" Comment: unclear on who was blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no dropouts reported, however difference in group allocation (37 versus 32). The authors may not have reported any possible dropouts, only reporting those available at the end of the study |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes in methods section were reported. Unclear what plaque index and gingival health index were used but unlikely to influence outcome |
| Other bias | Unclear risk | Unclear baseline comparability and ITT not completed Method states DMFS to be scored but within abstract and results table dmft is reported |