Clinical Research
Radiographic evaluation of a bone substitute material in alveolar ridge preservation for maxillary removable immediate dentures: A randomized controlled trial

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Abstract

Statement of problem

Maxillary bone resorption after multiple extractions can jeopardize the success of an immediate denture, but whether bone volume preservation techniques are effective is unclear.

Purpose

The purpose of this randomized controlled trial was to evaluate the efficacy of socket grafting with a xenogenic bone substitute in participants receiving maxillary immediate removable complete dentures in terms of bone volume preservation (height and width of the bone ridge).

Material and methods

The study was a single-blinded, randomized controlled clinical trial with 2 balanced parallel arms. Thirty-six participants who had Kennedy Class I edentulous posterior areas bilaterally for at least 3 months and required maxillary immediate removable complete dentures were enrolled. Duplicates of the removable complete denture were made and converted into radiographic and surgical guides. Participants allocated to the test group received deproteinized bovine bone mineral blended with 10% porcine collagen (DBBM-C) in the extraction sockets, and participants in the control group received no grafting material. With a radiographic guide in place, cone beam computed tomography scans were made 10 days after tooth extraction, when the immediate removable complete denture was delivered (D10, baseline), after 3 months (D90), and after 1 year (D365). The scans were superimposed, and measurements were made on the cross-sectional plane of each extraction site. The influence of various prognosis factors associated with bone volume preservation, including the location of tooth extraction, smoking habits, periodontal disease, and operator team, were analyzed.

Results

Of 36 participants, 3 were lost to follow-up. The mean ±standard deviation loss of height of the buccal crest was 1.2 ±1.8 mm in the control group and 0.3 ±1.2 mm in the test group after 3 months of healing (P<.001) and 2.1 ±2.0 mm in the control group and 0.7 ±1.4 mm in the test group after 1 year of follow-up (P<.001). Mean ±standard deviation horizontal ridge width change was 1.3 ±1.4 mm in the control group and 0.5 ±0.8 mm in the test group after 3 months (P<.001) and 2.2 ±1.4 mm in the control group and 0.9 ±1.1 mm in the test group after 1 year of follow-up (P<.001). None of the other prognostic factors had a significant effect at either time period.

Conclusions

Grafting DBBM-C into the extraction socket after removing anterior teeth for immediate removable denture therapy resulted in significantly less vertical buccal crest and horizontal ridge resorption as compared with spontaneous socket healing after 1 year of follow-up. This procedure may be useful for preserving bone, especially when a fixed implant-supported prosthesis is planned.

Section snippets

Material and methods

The study was designed as a single-blinded, randomized controlled RCT with 2 balanced parallel arms. Participants were selected from patients requiring maxillary IRCDs visiting in the prosthodontic department of Henri Mondor Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP], France).

The trial was approved by the local ethics committee (CPP registration no. 13-019) and the National Agency for Medicines and Health Products (ANSM, registration no. 2013-A00440-45). This study was registered

Results

The Consolidated Standards of Reporting Trials (CONSORT) guidelines were used to report the results of this study. A total of 36 participants (19 men; mean ±standard deviation age 57 ±13.1 years; range 33 to 77) requiring maxillary IRCD were enrolled in this RCT, which started in October 2013 and ended in December 2018 (Fig. 2). Three participants were lost to follow-up. Randomization allowed participants to be equally distributed into 2 homogenous groups. Demographic data are presented in

Discussion

The research hypothesis that socket grafting would significantly decrease bone resorption in participants requiring IRCDs was confirmed by the study. Grafting DBBM-C into extraction sockets after removing anterior teeth for an IRCD resulted in significantly less vertical buccal-crest and horizontal ridge resorption as compared with spontaneous socket healing after 1 year of follow-up.

The present results were consistent with those of systematic reviews and meta-analyses that demonstrated the

Conclusions

Based on the findings of this randomized controlled trial, the following conclusions were drawn:

  • 1.

    Grafting DBBM-C into extraction sockets after removing anterior teeth for IRCD treatment resulted in significantly less vertical buccal-crest and horizontal ridge resorption as compared with spontaneous socket healing after 1 year.

  • 2.

    This procedure may be useful for preserving bone and improve prosthetic treatment for edentulous jaw therapy.

CRediT authorship contribution statement

Christophe Rignon-Bret: Conceptualization, Methodology, Investigation, Writing - original draft, Project administration. Claudine Wulfman: Investigation, Writing - review & editing. Fabien Valet: Formal analysis, Writing - review & editing. Alain Hadida: Investigation. Thien-Huong Nguyen: Methodology, Validation. Alexis Aidan: Validation, Data curation. Adrien Naveau: Visualization, Writing - original draft, Writing - review & editing.

Acknowledgments

The authors thank Geistlich Pharma AG (Wolhusen,

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    • Supported by a grant from the Ministry of Health of France through the national program for clinical research in hospitals (Programme Hospitalier de Recherche Clinique) [grant no. AOR12032-P111116]. The promoter is Assistance Publique-Hôpitaux de Paris. ClinicalTrials.gov: NCT02120053

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    © 2021 by the Editorial Council for the Journal of Prosthetic Dentistry.