Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

doi:10.1186/s13063-016-1646-0

Randomized Controlled Trial

. 2016 Nov 4;17(1):533.

doi: 10.1186/s13063-016-1646-0.

Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

Túlio Eduardo Nogueira¹, Shahrokh Esfandiari², Cláudio Rodrigues Leles³

Affiliations

¹ School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.
² Faculty of Dentistry, McGill University, 2001 McGill College Avenue, suite 500, Montreal, QC, H3A 1G1, Canada.
³ School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil. claudio_leles@ufg.br.

PMID: 27814749
PMCID: PMC5097429
DOI: 10.1186/s13063-016-1646-0

Randomized Controlled Trial

Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

Túlio Eduardo Nogueira et al. Trials. 2016.

. 2016 Nov 4;17(1):533.

doi: 10.1186/s13063-016-1646-0.

Authors

Túlio Eduardo Nogueira¹, Shahrokh Esfandiari², Cláudio Rodrigues Leles³

Affiliations

¹ School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.
² Faculty of Dentistry, McGill University, 2001 McGill College Avenue, suite 500, Montreal, QC, H3A 1G1, Canada.
³ School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil. claudio_leles@ufg.br.

PMID: 27814749
PMCID: PMC5097429
DOI: 10.1186/s13063-016-1646-0

Abstract

Background: Preliminary clinical studies on the single-implant mandibular overdenture (SIMO) have reported favorable results as an alternative to the conventional complete dentures for rehabilitation of the edentulous mandible. Clinical and patient-reported outcomes were assessed but no evidence is available with respect to the cost-effectiveness of this treatment, which is particularly important to test whether the incremental cost associated with the implant treatment is justified facing the benefits from the intervention. Thus, the aim of this study is to assess the cost-effectiveness of single-implant mandibular overdentures.

Methods/design: This randomized clinical trial will include edentulous individuals who meet eligibility criteria. Participants will be randomized into one of the treatment groups: a conventional complete denture group or a single-implant mandibular overdenture group. Direct costs related to therapies in both groups will be identified, measured and valuated for 1 year after treatment. Oral health-related quality of life and satisfaction with the dentures will be the primary outcome variables. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

Discussion: This is the first trial-based cost-effectiveness study on single-implant mandibular overdentures. Specific challenges in designing the protocol are considered. The expected results are of high clinical relevance and may contribute to the decision-making process when choosing between different alternatives for the rehabilitation of the edentulous mandible.

Trial registration: ClinicalTrials.gov Identifier: NCT02710357 , registered on 11 March 2016.

Keywords: Complete dentures; Cost-effectiveness; Dental economics; Economic evaluation; Overdentures; Patient satisfaction.

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References

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1. Petersen PE, Bourgeois D, Ogawa H, et al. The global burden of oral diseases and risks to oral health. Bull World Health Organ. 2005;83:661–9. - PMC - PubMed
1. Peres MA, Barbato PR, Reis SC, Freitas CH, Antunes JL. Tooth loss in Brazil: analysis of the 2010 Brazilian Oral Health Survey. Rev Saude Publica. 2013;47(Suppl 3):78–89. doi: 10.1590/S0034-8910.2013047004226. - DOI - PubMed
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1. Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, et al. The McGill Consensus Statement on Overdentures. Montreal, Quebec, Canada. May 24–25, 2002. Int J Prosthodont. 2002;15:413–4. - PubMed

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[1] Cooper LF. The current and future treatment of edentulism. J Prosthodont. 2009;18:116–22. doi: 10.1111/j.1532-849X.2009.00441.x. - DOI - PubMed

[2] Cooper LF. The current and future treatment of edentulism. J Prosthodont. 2009;18:116–22. doi: 10.1111/j.1532-849X.2009.00441.x. - DOI - PubMed

[3] Petersen PE, Bourgeois D, Ogawa H, et al. The global burden of oral diseases and risks to oral health. Bull World Health Organ. 2005;83:661–9. - PMC - PubMed

[4] Petersen PE, Bourgeois D, Ogawa H, et al. The global burden of oral diseases and risks to oral health. Bull World Health Organ. 2005;83:661–9. - PMC - PubMed

[5] Peres MA, Barbato PR, Reis SC, Freitas CH, Antunes JL. Tooth loss in Brazil: analysis of the 2010 Brazilian Oral Health Survey. Rev Saude Publica. 2013;47(Suppl 3):78–89. doi: 10.1590/S0034-8910.2013047004226. - DOI - PubMed

[6] Peres MA, Barbato PR, Reis SC, Freitas CH, Antunes JL. Tooth loss in Brazil: analysis of the 2010 Brazilian Oral Health Survey. Rev Saude Publica. 2013;47(Suppl 3):78–89. doi: 10.1590/S0034-8910.2013047004226. - DOI - PubMed

[7] Carlsson GE, Omar R. The future of complete dentures in oral rehabilitation. A critical review. J Oral Rehabil. 2010;37:143–56. doi: 10.1111/j.1365-2842.2009.02039.x. - DOI - PubMed

[8] Carlsson GE, Omar R. The future of complete dentures in oral rehabilitation. A critical review. J Oral Rehabil. 2010;37:143–56. doi: 10.1111/j.1365-2842.2009.02039.x. - DOI - PubMed

[9] Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, et al. The McGill Consensus Statement on Overdentures. Montreal, Quebec, Canada. May 24–25, 2002. Int J Prosthodont. 2002;15:413–4. - PubMed

[10] Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, et al. The McGill Consensus Statement on Overdentures. Montreal, Quebec, Canada. May 24–25, 2002. Int J Prosthodont. 2002;15:413–4. - PubMed

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Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

Affiliations

Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

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Medical