The trial was approved by the French Ethics Committee for the Protection of Persons (Comit de Protection de Personnes, Département de la Recherche Clinique et de l’Enseignement Superieur (DRCES), Pitié-Salpetrière, Paris, France) in June 2013 (number 13-019). The protocol is registered with the Agence Nationale pour la Scurit du mdicament et des Produits de Sant (ANSM, French National Agency for Medicines and Health Products Safety (2013-A00440-45) and ClinicalTrials.gov (no. NCT02120053, 18 April 2014). All amendments to the protocol will be justified, submitted to the scientific board, accepted by the CPP, and recorded by the ANSM. Changes and amendments will be also recorded at ClinicalTrials.gov. Informed consent will be obtained from trial participants after the trial is explained by an investigator or operator of the corresponding center. Patients are informed that they have the right to withdraw from the study at any time without giving reasons. Regardless of withdrawal, patients will be provided any treatment in their best interest. Withdrawal will be documented. Data confidentiality was audited by the Comit National Informatique et Libert (National Committee of Informatics and Freedom) (DRCES, Pitié-Salpetrière, Paris, France) and the authors followed the SPIRIT 2013 checklist (Fig. 6).
This article describes the use of an innovative design in removable partial dentures to improve patient comfort and esthetics. The concept of improving patient comfort by modifying the rigidity of removable partial denture clasps has been described by Buser and associates.8 In the present study, the use of an innovative design is described that is more esthetically pleasing and provides improved patient comfort. The key to this innovation lies in the placement of clasps on the palatal surface of premolars. This concept does not jeopardize the function and integrity of the removable partial denture, it is easily reversible and does not result in accumulation of plaque or debris in the palatal region.
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