Open AccessEfficacy, tolerability, and safety of an innovative medical device for improving oral accessibility during oral examination in special-needs patients: A multicentric clinical trial
Author(s) -
Mathieu Mogenot,
Laurence Hein-Halbgewachs,
Christophe Goetz,
Nadia Ouamara,
Dominique Droz-Desprez,
C. Strazielle,
Sylvie Albecker,
Brigitte Mengus,
Marion Strub,
MarieCécile Manière,
Pascal Richardin,
Stéphane Wang,
Giuseppa Piga,
Amélie Dalstein,
Daniel Anastasio
Publication year - 2020
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0239898
Subject(s) - medicine , tolerability , physical examination , clinical trial , cohort , prospective cohort study , adverse effect , randomized controlled trial , physical therapy , dentistry , surgery
Background People 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. Methods The 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). Results The 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. Conclusion The spatula significantly improved oral access, was safe and well-tolerated by the patients, and markedly improved oral examination quality.