Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial

Christophe Rignon-Bret, Alain Hadida, Alexis Aidan, Thien-Huong Nguyen, Gerard Pasquet, Helene Fron-Chabouis, Claudine Wulfman, Christophe Rignon-Bret, Alain Hadida, Alexis Aidan, Thien-Huong Nguyen, Gerard Pasquet, Helene Fron-Chabouis, Claudine Wulfman

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov, NCT02120053 . Registered on 18 April 2014.

Keywords: Bone substitute; Clinical trial; Complete denture; Socket graft.

Figures

Fig. 1
Fig. 1
Participant flow diagram
Fig. 2
Fig. 2
Study overview
Fig. 3
Fig. 3
Radiographic guide with pits next to extraction sites
Fig. 4
Fig. 4
Schematic measurement principles. h is the height measurement, the distance between the palatal pit end (reference point O) and the buccal top of the outer cortical bone. l is the bone ridge width, measured on a bucco-lingual line crossing the alveolar socket, perpendicular to the palatal pit axis and at a distance of 6 mm or two thirds of the socket depth (depending on the patient’s bone morphology) from the reference point O
Fig. 5
Fig. 5
Participant’s timeline
Fig. 6
Fig. 6
SPIRIT 2013 checklist

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