Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial
Identifieur interne : 000012 ( France/Analysis ); précédent : 000011; suivant : 000013Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial
Auteurs : Christophe Rignon-Bret [France] ; Alain Hadida [France] ; Alexis Aidan [France] ; Thien-Huong Nguyen [France] ; Gerard Pasquet [France] ; Helene Fron-Chabouis [France] ; Claudine Wulfman [France]Source :
- Trials [ 1745-6215 ] ; 2016.
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,
Url:
DOI: 10.1186/s13063-016-1380-7
PubMed: 27206923
PubMed Central: 4875593
Affiliations:
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PMC:4875593Le document en format XML
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France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Albert Chevenier Hospital, Assistance Publique – Hôpitaux de Paris, 40 rue de Mesly, 94000 Créteil</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region><settlement type="city">Créteil</settlement></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="Aff2">Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006 Paris</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region><settlement type="city">Paris</settlement><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Hadida, Alain" sort="Hadida, Alain" uniqKey="Hadida A" first="Alain" last="Hadida">Alain Hadida</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Albert Chevenier Hospital, Assistance Publique – Hôpitaux de Paris, 40 rue de Mesly, 94000 Créteil, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Albert Chevenier Hospital, Assistance Publique – Hôpitaux de Paris, 40 rue de Mesly, 94000 Créteil</wicri:regionArea><wicri:noRegion>94000 Créteil</wicri:noRegion><wicri:noRegion>94000 Créteil</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:aff id="Aff3">Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006 Paris</wicri:regionArea><wicri:noRegion>75006 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" 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179, rue Saint-Honoré, 75001 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Cabinet de Radiologie Dentaire Echelle Saint-Honoré, 179, rue Saint-Honoré, 75001 Paris</wicri:regionArea><wicri:noRegion>75001 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Pasquet, Gerard" sort="Pasquet, Gerard" uniqKey="Pasquet G" first="Gerard" last="Pasquet">Gerard Pasquet</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Cabinet de Radiologie Dentaire Echelle Saint-Honoré, 179, rue Saint-Honoré, 75001 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Cabinet de Radiologie Dentaire Echelle Saint-Honoré, 179, rue Saint-Honoré, 75001 Paris</wicri:regionArea><wicri:noRegion>75001 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Fron Chabouis, Helene" sort="Fron Chabouis, Helene" uniqKey="Fron Chabouis H" first="Helene" last="Fron-Chabouis">Helene Fron-Chabouis</name><affiliation wicri:level="4"><nlm:aff id="Aff2">Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006 Paris</wicri:regionArea><wicri:noRegion>75006 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff5">Charles Foix Hospital, Assistance Publique – Hôpitaux de Paris, 7 avenue de la République, 94200 Ivry-sur-Seine, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Charles Foix Hospital, Assistance Publique – Hôpitaux de Paris, 7 avenue de la République, 94200 Ivry-sur-Seine</wicri:regionArea><wicri:noRegion>94200 Ivry-sur-Seine</wicri:noRegion><wicri:noRegion>94200 Ivry-sur-Seine</wicri:noRegion></affiliation></author><author><name sortKey="Wulfman, Claudine" sort="Wulfman, Claudine" uniqKey="Wulfman C" first="Claudine" last="Wulfman">Claudine Wulfman</name><affiliation wicri:level="4"><nlm:aff id="Aff2">Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006 Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Biomaterials Department (URB2i, EA4462), Sorbonne Paris Cité, Faculté de Chirurgie Dentaire, Université Paris Descartes, 75006 Paris</wicri:regionArea><wicri:noRegion>75006 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff6">Louis Mourier Hospital, Assistance Publique – Hôpitaux de Paris, 178 Rue des Renouillers, 92700 Colombes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Louis Mourier Hospital, Assistance Publique – Hôpitaux de Paris, 178 Rue des Renouillers, 92700 Colombes</wicri:regionArea><wicri:noRegion>92700 Colombes</wicri:noRegion><wicri:noRegion>92700 Colombes</wicri:noRegion></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods/design</title><p>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.</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/">NCT02120053</ext-link>. Registered on 18 April 2014.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Douglass, Cw" uniqKey="Douglass C">CW Douglass</name></author><author><name sortKey="Jimenez, Mc" uniqKey="Jimenez M">MC Jiménez</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Douglass, Cw" uniqKey="Douglass C">CW Douglass</name></author><author><name sortKey="Shih, A" uniqKey="Shih A">A Shih</name></author><author><name sortKey="Ostry, L" uniqKey="Ostry L">L Ostry</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zarb, Ga" uniqKey="Zarb G">GA Zarb</name></author><author><name sortKey="Hobkirk, Ja" uniqKey="Hobkirk J">JA Hobkirk</name></author><author><name sortKey="Eckert, S" uniqKey="Eckert S">S Eckert</name></author><author><name sortKey="Jacobs, R" uniqKey="Jacobs R">R Jacobs</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rignon Bret, C" 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Kotsakis</name></author><author><name sortKey="Javed, F" uniqKey="Javed F">F Javed</name></author><author><name sortKey="Hinrichs, Je" uniqKey="Hinrichs J">JE Hinrichs</name></author><author><name sortKey="Karoussis, Ik" uniqKey="Karoussis I">IK Karoussis</name></author><author><name sortKey="Romanos, Ge" uniqKey="Romanos G">GE Romanos</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chrcanovic, Br" uniqKey="Chrcanovic B">BR Chrcanovic</name></author><author><name sortKey="Albrektsson, T" uniqKey="Albrektsson T">T Albrektsson</name></author><author><name sortKey="Wennerberg, A" uniqKey="Wennerberg A">A Wennerberg</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Schropp, L" uniqKey="Schropp L">L Schropp</name></author><author><name sortKey="Wenzel, A" uniqKey="Wenzel A">A Wenzel</name></author><author><name sortKey="Kostopoulos, L" uniqKey="Kostopoulos L">L Kostopoulos</name></author><author><name sortKey="Karring, T" uniqKey="Karring T">T Karring</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Araujo, Mg" uniqKey="Araujo M">MG Araújo</name></author><author><name sortKey="Lindhe, J" uniqKey="Lindhe J">J Lindhe</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>France</li></country><region><li>Île-de-France</li></region><settlement><li>Créteil</li><li>Paris</li></settlement><orgName><li>Université Paris-Descartes</li></orgName></list><tree><country name="France"><region name="Île-de-France"><name sortKey="Rignon Bret, Christophe" sort="Rignon Bret, Christophe" uniqKey="Rignon Bret C" first="Christophe" last="Rignon-Bret">Christophe Rignon-Bret</name></region><name sortKey="Aidan, Alexis" sort="Aidan, Alexis" uniqKey="Aidan A" first="Alexis" last="Aidan">Alexis Aidan</name><name sortKey="Fron Chabouis, Helene" sort="Fron Chabouis, Helene" uniqKey="Fron Chabouis H" first="Helene" last="Fron-Chabouis">Helene Fron-Chabouis</name><name sortKey="Fron Chabouis, Helene" sort="Fron Chabouis, Helene" uniqKey="Fron Chabouis H" first="Helene" last="Fron-Chabouis">Helene Fron-Chabouis</name><name sortKey="Hadida, Alain" sort="Hadida, Alain" uniqKey="Hadida A" first="Alain" last="Hadida">Alain Hadida</name><name sortKey="Hadida, Alain" sort="Hadida, Alain" uniqKey="Hadida A" first="Alain" last="Hadida">Alain Hadida</name><name sortKey="Nguyen, Thien Huong" sort="Nguyen, Thien Huong" uniqKey="Nguyen T" first="Thien-Huong" last="Nguyen">Thien-Huong Nguyen</name><name sortKey="Pasquet, Gerard" sort="Pasquet, Gerard" uniqKey="Pasquet G" first="Gerard" last="Pasquet">Gerard Pasquet</name><name sortKey="Rignon Bret, Christophe" sort="Rignon Bret, Christophe" uniqKey="Rignon Bret C" first="Christophe" last="Rignon-Bret">Christophe Rignon-Bret</name><name sortKey="Wulfman, Claudine" sort="Wulfman, Claudine" uniqKey="Wulfman C" first="Claudine" last="Wulfman">Claudine Wulfman</name><name sortKey="Wulfman, Claudine" sort="Wulfman, Claudine" uniqKey="Wulfman C" first="Claudine" last="Wulfman">Claudine Wulfman</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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