Trial reportPloS one2020
Efficacy, tolerability, and safety of an innovative medical device for improving oral accessibility during oral examination in special-needs patients: A multicentric clinical trial.
Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02818374 (Evaluation of the Efficacy and Safety of Use of an Innovative Medical Device for Improving Oral Accessibility in People With Disabilities, Presenting Behavioral Disorders), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of the Efficacy and Safety of Use of an Innovative Medical Device for Improving Oral Accessibility in People With Disabilities, Presenting Behavioral Disorders: The Oral Accessibility Spatula (Spatule SAB)
Who cites it
1 citing paper in PubMed.
- Huntington's Disease and Dentistry: A Review of Its Etiology, Clinical Presentation, Symptomatic Pharmacotherapy, and Dental Management.Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric DentistryReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPeople with special needs have high unmet oral healthcare needs, partly because dentists find it difficult to access their oral cavity. The Oral Accessibility Spatula aims to improve oral accessibility. This prospective multicenter interventional open-label non-randomized patient-self-controlled trial assessed the ability of the spatula to improve the oral accessibility of special-needs patients during dental examinations.
methodsThe cohort was a convenience sample of minor and adult patients with special needs due to physical, intellectual, and/or behavioral disorders who underwent dental check-up/treatment in five French tertiary hospitals/private clinics in 2016-2018 and evinced some (Venham-Score = 2-4) but not complete (Venham-Score = 5) resistance to oral examination. After inclusion, patients underwent oral examination without the spatula and then immediately thereafter oral examination with the spatula. Primary outcome was Oral Accessibility Score (0-12 points; higher scores indicate visualization and probing of the tooth sectors). Secondary outcomes were patient toleration (change in Venham-Score relative to first examination), safety, and Examiner Satisfaction Score (0-10; low scores indicate unsatisfactory examination).
resultsThe 201 patients were mostly non-elderly adults (18-64 years, 65%) but also included children (21%), adolescents (11%), and aged patients (3%). One-quarter, half, and one-quarter had Venham-Score = 2, 3, and 4 at inclusion, respectively. The spatula significantly improved Oral Accessibility Score (4.8 to 10.8), Venham-Score (3.1 to 2.6), and Examiner Satisfaction Score (3.4 to 7.2) (all p<0.001). There were no severe spatula-related adverse events.
conclusionThe spatula significantly improved oral access, was safe and well-tolerated by the patients, and markedly improved oral examination quality.
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