Samir Abou-Ayash1,2, Nadine von Maltzahn3, Nicole Passia4, Sandra Freitag-Wolf5, Daniel R Reissmann6, Ralph G Luthardt7, Torsten Mundt8, Michael Raedel9, Peter Rammelsberg10, Stefan Wolfart11, Matthias Kern4. 1. Department of Prosthodontics, University Hospital Freiburg, Freiburg, Germany. samir.abou-ayash@zmk.unibe.ch. 2. Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine University of Bern, Freiburgstrasse 7, 3010, Bern, Switzerland. samir.abou-ayash@zmk.unibe.ch. 3. Department of Prosthodontics, University Hospital Hannover, Hannover, Germany. 4. Department of Prosthodontics, Propaedeutics and Dental Materials, Christian-Albrechts University of Kiel, Kiel, Germany. 5. Center for Clinical Studies, Christian-Albrechts University of Kiel and Institute for Medical Informatics and Statistics, Christian-Albrechts-University, Kiel, Germany. 6. Department of Prosthetic Dentistry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 7. Center of Dentistry, Department of Prosthetic Dentistry, Ulm University Hospital, Ulm, Germany. 8. Department of Prosthodontics, Gerodontology and Biomaterials, Greifswald University Hospital, Greifswald, Germany. 9. Prosthodontics, Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany. 10. Department of Prosthodontics, Heidelberg University Hospital, Heidelberg, Germany. 11. Department of Prosthodontics and Biomaterials, University Hospital Aachen, Aachen, Germany.
Abstract
OBJECTIVES: The knowledge about the influence of dental treatment on health-related quality of life (HRQoL) is still limited. The aim of this multicenter randomized controlled clinical trial was to assess the effect of stabilizing an existing complete denture, by means of a single mandibular implant, on HRQoL. Furthermore, the impact of the loading protocol, i.e., immediate or delayed loading, in edentulous patients was evaluated. METHODS:One hundred fifty-eight participants aged 60-89 years were randomly assigned to study group A (immediate loading; n = 81) and to group B (delayed loading; n = 78). All participants received a single midline implant in the mandible. The implants were either immediately loaded (group A) or after a closed healing period of 3 months (group B) by connecting the existing mandibular complete dentures to ball attachments. HRQoL was assessed with the Short Form-36 questionnaire of health (SF-36) at baseline, 4 months, and 24 months after implant loading. RESULTS: Improvement of HRQoL by means of a single implant-retained mandibular overdenture could not be demonstrated after 4 and 24 months of implant loading. Furthermore, the application of two different loading protocols did not influence HRQoL ratings of study participants. CONCLUSION: The loading protocol is not a factor, influencing HRQoL in patients treated by a single midline implant in the edentulous mandible. CLINICAL RELEVANCE: A single midline implant in the edentulous mandible, stabilizing a mandibular complete denture, cannot be recommended for improving HRQoL.
RCT Entities:
OBJECTIVES: The knowledge about the influence of dental treatment on health-related quality of life (HRQoL) is still limited. The aim of this multicenter randomized controlled clinical trial was to assess the effect of stabilizing an existing complete denture, by means of a single mandibular implant, on HRQoL. Furthermore, the impact of the loading protocol, i.e., immediate or delayed loading, in edentulous patients was evaluated. METHODS: One hundred fifty-eight participants aged 60-89 years were randomly assigned to study group A (immediate loading; n = 81) and to group B (delayed loading; n = 78). All participants received a single midline implant in the mandible. The implants were either immediately loaded (group A) or after a closed healing period of 3 months (group B) by connecting the existing mandibular complete dentures to ball attachments. HRQoL was assessed with the Short Form-36 questionnaire of health (SF-36) at baseline, 4 months, and 24 months after implant loading. RESULTS: Improvement of HRQoL by means of a single implant-retained mandibular overdenture could not be demonstrated after 4 and 24 months of implant loading. Furthermore, the application of two different loading protocols did not influence HRQoL ratings of study participants. CONCLUSION: The loading protocol is not a factor, influencing HRQoL in patients treated by a single midline implant in the edentulous mandible. CLINICAL RELEVANCE: A single midline implant in the edentulous mandible, stabilizing a mandibular complete denture, cannot be recommended for improving HRQoL.
Entities:
Keywords:
Overdenture; Patient-reported outcomes; Quality of life; SF-36; Single mandibular implant