Van der Putten 2013.
Methods | Cluster‐randomised controlled trial, 2 arms Study period: not reported Planned follow‐up period: 6 months |
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Participants | Country: Netherlands Setting: 12 nursing homes Target audience for the intervention: nursing home staff Number of randomised participants (nursing home residents): 343 Number of analysed participants (nursing home residents): 232 Age, mean, years (SD): 80.4 (9.4) in IG, 80.7 (10.9) in CG Female: 66% in IG, 69% in CG Edentulous: 70% in IG, 62% in CG Residents with dental prosthesis: 84% in IG, 75% in CG Inclusion criteria: having teeth and/or (removable) partial or complete dentures; physically suitable for examination; expected to be residing in the care home during the entire 6‐month period Exclusion criteria: residents in day care, in short‐term residency (on a rehabilitation ward, residing 2 weeks to 3 months = less than 6 months on this ward), in coma, in palliative care or terminally ill, using a denture adhesive, expressing verbal or physical resistiveness before or during an oral examination |
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Interventions |
Intervention group Supervised implementation of the "Oral health care Guideline for Older people in Long‐term care Institutions (OGOLI)" including multiple components: Education/skills training:
Information material:
Additional components:
Control group Usual oral health care according to the no‐supervised implemented guideline (since 2007 Dutch guideline OGOLI) Co‐interventions (for the intervention group)
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Outcomes |
Primary outcomes Oral hygiene measures were assessed at baseline and 6 months after the start of the study.
Planned outcomes
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Funding | Research project is funded by Open Ankh Foundation, Utrecht; The Opbouw Foundation, Utrecht; ZonMw, The Hague; Vereniging Zonnehuis, Amstelveen; Stichting Wetenschapsbevordering Verpleeghuiszorg, Amsterdam; MarkTwo Communications, Leusden und Fonds NutsOhra, Amsterdam. Oral healthcare products were provided free by GABA International, NoviaCura, and Johnson & Johnson. |
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Notes | Publication of oral health‐related knowledge and attitude in preparation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "allocated randomly" Comment: Probably done, since another report from the same investigators (one study protocol for both trials) described use of "computer‐aided tools" |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding of participants and personnel or incomplete blinding, but the review authors judge that the assessed outcomes are not likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "examiners were blinded" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Over the course of the trial, 111 of the residents (32%) were lost to follow‐up, 62 (35%) in the intervention group and 49 (29.5%) in the control group. There were no significant differences in loss to follow‐up between the intervention and the control group (Chi‐square, p=0.18). The main reasons for loss to follow‐up were: deceased (66%), administrative error (7%), moved to another care home or otherwise absent (8%), intermediate disease (14%) or refusal (5%). There were also no statistically significant differences in residents’ personal and medical characteristics and dental and denture plaque scores at baseline between residents who completed the study and those who did not." |
Selective reporting (reporting bias) | Low risk | Additional outcomes planned in the protocol (knowledge and attitude of nursing staff), paper in preparation for knowledge and attitude results (correspondence) |
Other bias | Low risk | None apparent |