title: Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial.
abstract: Bone preservation is an essential issue in the context of last teeth extraction and complete edentulism. The intended treatment, whether a complete denture or an implant placement, is facilitated with a voluminous residual ridge. Bone resorption after multiple extractions has not been as well studied as the bone resorption that occurs after the extraction of a single tooth. Recent advances in bone substitute materials have revived this issue. The purpose of this study is to evaluate the interest in using bone substitute material to fill the socket after last teeth extraction in a maxillary immediate complete denture procedure compared with the conventional protocol without socket filling.
  
  
  
  A randomized, controlled, clinical trial was designed. The 34 participants eligible for maxillary immediate complete denture were divided into two groups. Complete dentures were prepared despite persistence of the last anterior teeth. The control group received a conventional treatment including denture placement immediately after extractions. In the experimental group, in addition to the immediate denture placement, a xenograft bone-substitute material (Bio-Oss Collagen®) was placed in the fresh sockets. The primary outcome of the study is to compare mean bone ridge height loss 1 year after maxillary immediate complete denture placement, with or without bone-substitute material, in incisor and canine sockets. The secondary outcomes are to compare the average bone ridge height and width loss for each extraction site. An original quantitative evaluation method using cone beam computed tomography was designed for reproducible measurements, with a radio-opaque denture duplicate. Two independent operators perform the radiologic measurements.
  
  
  
  The immediate complete denture technique limits bone resorption in multiple extraction situations and thus allows better denture retention and better options for implant placement. To compare the benefit of using any bone socket-filling material, we proposed a quantitative evaluation protocol of resorption in the specific case of the last anterior maxillary teeth extraction with immediate denture placement.
  
  
  
  ClinicalTrials.gov, NCT02120053 . Registered on 18 April 2014.
authors.affiliation: Albert Chevenier Hospital, Assistance Publique - Hôpitaux de Paris, 40 rue de Mesly, 94000, Créteil, France. rignon-bret@wanadoo.fr.|Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006, Paris, France. rignon-bret@wanadoo.fr.
authors.forename: Christophe
authors.initials: C
authors.lastname: Rignon-Bret
authors.affiliation: Albert Chevenier Hospital, Assistance Publique - Hôpitaux de Paris, 40 rue de Mesly, 94000, Créteil, France.|Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006, Paris, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Hadida
authors.affiliation: Albert Chevenier Hospital, Assistance Publique - Hôpitaux de Paris, 40 rue de Mesly, 94000, Créteil, France.
authors.forename: Alexis
authors.initials: A
authors.lastname: Aidan
authors.affiliation: Cabinet de Radiologie Dentaire Echelle Saint-Honoré, 179, rue Saint-Honoré, 75001, Paris, France.
authors.forename: Thien-Huong
authors.initials: TH
authors.lastname: Nguyen
authors.affiliation: Cabinet de Radiologie Dentaire Echelle Saint-Honoré, 179, rue Saint-Honoré, 75001, Paris, France.
authors.forename: Gerard
authors.initials: G
authors.lastname: Pasquet
authors.affiliation: Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006, Paris, France.|Charles Foix Hospital, Assistance Publique - Hôpitaux de Paris, 7 avenue de la République, 94200, Ivry-sur-Seine, France.
authors.forename: Helene
authors.initials: H
authors.lastname: Fron-Chabouis
authors.affiliation: Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006, Paris, France.|Louis Mourier Hospital, Assistance Publique - Hôpitaux de Paris, 178 Rue des Renouillers, 92700, Colombes, France.
authors.forename: Claudine
authors.initials: C
authors.lastname: Wulfman
mesh_terms: D016301:Alveolar Bone Loss / Q000000981:diagnostic imaging / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D018786:Bone Substitutes / Q000009:adverse effects / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000009:adverse effects / Q000379:methods*; D002985:Clinical Protocols; D054893:Cone-Beam Computed Tomography; D003824:Denture, Complete; D005602:France; D064593:Heterografts; D006801:Humans; D008437:Maxilla / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D008903:Minerals / Q000009:adverse effects / Q000627:therapeutic use*; D011861:Radiography, Dental / Q000379:methods; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D014081:Tooth Extraction; D020390:Tooth Socket / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: C077540:Bio-Oss; D018786:Bone Substitutes; D008903:Minerals
keywords: Bone substitute; Clinical trial; Complete denture; Socket graft