Implant survival/success and peri-implant outcomes of titanium-zirconium mini implants for mandibular overdentures: Results from a 1-year randomized clinical trial

Thalita Fernandes Fleury Curado, Jésio Rodrigues Silva, Lays Noleto Nascimento, José Luiz Rodrigues Leles, Gerald McKenna, Martin Schimmel, Cláudio Rodrigues Leles, Thalita Fernandes Fleury Curado, Jésio Rodrigues Silva, Lays Noleto Nascimento, José Luiz Rodrigues Leles, Gerald McKenna, Martin Schimmel, Cláudio Rodrigues Leles

Abstract

Objective: To report the 1-year implant survival/success and peri-implant outcomes of mandibular overdentures retained by four titanium-zirconium mini implants (Straumann® Mini Implant System), and to assess how surgery and loading protocols influence these outcomes.

Materials and methods: A 2 × 2 factorial randomized clinical trial (RCT) tested the combined effects of two loading protocols (immediate or delayed) and two surgical approaches (flapless or flapped) on the success/survival of the mini implants, and peri-implant parameters (plaque, bleeding, sulcus depth, gingival position, and marginal bone loss). Outcomes were assessed up to 1-year after loading, and generalized estimating equations (GEEs) were used to analyze longitudinal and within-patient clustered data.

Results: Two hundred and ninety-six implants were placed in 74 patients. The implant survival/success rates after 1 year were 100%, and no major biological complications were observed. After 1-year, descriptive data suggest no noticeable changes in plaque scores, whilst a reduction in bleeding scores at the 6-month and 1-year follow-ups compared to baseline. Good longitudinal stability was observed for the probing depth and gingival margin height measures. Overall mean marginal bone loss was 0.68 (±0.68) mm after 3 months and 0.89 (±0.75) mm after 1-year. The flapless protocol showed better results on soft tissue stability and health but a slightly higher risk for marginal bone loss.

Conclusion: The results of this RCT suggest that mandibular overdentures retained by this novel mini implant system represent a safe and predictable treatment option as confirmed by implant survival/success and peri-implant outcomes, even when flapless surgery and immediate loading protocols are adopted.

Keywords: clinical assessment; clinical research; clinical trials; dental implant; diagnosis; edentulous patient.

© 2023 The Authors. Clinical Oral Implants Research published by John Wiley & Sons Ltd.

References

REFERENCES

    1. Al-Nawas, B., Brägger, U., Meijer, H. J., Naert, I., Persson, R., Perucchi, A., Quirynen, M., Raghoebar, G. M., Reichert, T. E., Romeo, E., Santing, H. J., Schimmel, M., Storelli, S., ten Bruggenkate, C., Vandekerckhove, B., Wagner, W., Wismeijer, D., & Müller, F. (2012). A double-blind randomized controlled trial (RCT) of Titanium-13Zirconium versus Titanium Grade IV small-diameter bone level implants in edentulous mandibles-Results from a 1-year observation period. Clinical Oral Implants Research, 14(6), 896-904.
    1. Aunmeungtong, W., Kumchai, T., Strietzel, F. P., Reichart, P. A., & Khongkhunthian, P. (2017). Comparative clinical study of conventional dental implants and mini dental implants for mandibular overdentures: A randomized clinical trial. Clinical Implant Dentistry and Related Research, 19(2), 328-340.
    1. Borges, G. A., Codello, D. J., Del Rio Silva, L., Dini, C., Barão, V. A. R., & Mesquita, M. F. (2022). Factors and clinical outcomes for standard and mini-implants retaining mandibular overdentures: A systematic review and meta-analysis. Journal of Prosthetic Dentistry, S0022-3913(21)00635-1.
    1. Buser, D., Janner, S. F., Wittneben, J. G., Brägger, U., Ramseier, C. A., & Salvi, G. E. (2012). 10-year survival and success rates of 511 titanium implants with a sandblasted and acid-etched surface: A retrospective study in 303 partially edentulous patients. Clinical Implant Dentistry and Related Research, 14(6), 839-851.
    1. Büttel, A. E., Gratwohl, D. A., Sendi, P., & Marinello, C. P. (2012). Immediate loading of two unsplinted mandibular implants in edentulous patients with an implant-retained overdenture: An observational study over two years. Schweizer Monatsschrift für Zahnmedizin, 122(5), 392-397.
    1. Cawood, J. I., & Howell, R. A. (1988). A classification of the edentulous jaws. International Journal of Oral and Maxillofacial Surgery, 17(4), 232-236.
    1. Corbella, S., Del Fabbro, M., Taschieri, S., De Siena, F., & Francetti, L. (2011). Clinical evaluation of an implant maintenance protocol for the prevention of peri- implant diseases in patients treated with immediately loaded full-arch rehabilitations. International Journal of Dental Hygiene, 9(3), 216-222.
    1. de Souza, R. F., Ribeiro, A. B., Della Vecchia, M. P., Costa, L., Cunha, T. R., Reis, A. C., & Albuquerque, R. F., Jr. (2015). Mini vs. standard implants for mandibular overdentures: A randomized trial. Journal of Dental Research, 94(10), 1376-1384.
    1. Della Vecchia, M. P., Leles, C. R., Cunha, T. R., Ribeiro, A. B., Sorgini, D. B., Muglia, V. A., Reis, A. C., Albuquerque, R. F., Jr., & de Souza, R. F. (2018). Mini-implants for mandibular overdentures: Cost-effectiveness analysis alongside a randomized trial. JDR Clinical & Translational Research, 3(1), 47-56.
    1. do Nascimento, C., Miani, P. K., Pedrazzi, V., Gonçalves, R. B., Ribeiro, R. F., Faria, A. C., Macedo, A. P., & de Albuquerque, R. F., Jr. (2012). Leakage of saliva through the implant-abutment interface: in vitro evaluation of three different implant connections under unloaded and loaded conditions. International Journal of Oral and Maxillofacial Implants, 27(3), 551-560.
    1. Enkling, N., Moazzin, R., Geers, G., Kokoschka, S., Abou-Ayash, S., & Schimmel, M. (2020). Clinical outcomes and bone-level alterations around one-piece mini dental implants retaining mandibular overdentures: 5-year follow-up of a prospective cohort study. Clinical Oral Implants Research, 31(6), 549-556.
    1. Feine, J. S., Carlsson, G. E., Awad, M. A., Chehade, A., Duncan, W. J., Gizani, S., Head, T., Heydecke, G., Lund, J. P., Macentee, M., Mericske-Stern, R., Mojon, P., Morais, J. A., Naert, I., Payne, A. G., Penrod, J., Stoker, G. T., Tawse-Smith, A., Taylor, T. D., … Wismeijer, D. (2002). The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Gerodontology, 19, 3-4.
    1. Hahn, J. (2000). Single-stage, immediate loading, and flapless surgery. The Journal of Oral Implantology, 26(3), 193-198. <0193:SILAFS>;2
    1. Ho, W. F., Chen, W. K., Wu, S. C., & Hsu, H. C. (2008). Structure, mechanical properties, and grindability of dental Ti-Zr alloys. Journal of Materials Science: Materials in Medicine, 19(10), 3179-3186.
    1. Holmgren, E. P., Seckinger, R. J., Kilgren, L. M., & Mante, F. (1998). Evaluating parameters of osseointegrated dental implants using finite element analysis-A two-dimensional comparative study examining the effects of implant diameter, implant shape, and load direction. The Journal of Oral Implantology, 24(2), 80-88. <0080:EPOODI>;2
    1. Jung, R. E., Al-Nawas, B., Araujo, M., Avila-Ortiz, G., Barter, S., Brodala, N., Chappuis, V., Chen, B., De Souza, A., Almeida, R. F., Fickl, S., Finelle, G., Ganeles, J., Gholami, H., Hammerle, C., Jensen, S., Jokstad, A., Katsuyama, H., Kleinheinz, J., … Windisch, P. (2018). Group 1 ITI consensus report: The influence of implant length and design and medications on clinical and patient-reported outcomes. Clinical Oral Implants Research, 29(Suppl 16), 69-77.
    1. Juszczak, E., Altman, D. G., Hopewell, S., & Schulz, K. (2019). Reporting of multi-arm parallel-group randomized trials: Extension of the CONSORT 2010 statement. Journal of the American Medical Association, 321(16), 1610-1620.
    1. Klein, M. O., Schiegnitz, E., & Al-Nawas, B. (2014). Systematic review on success of narrow-diameter dental implants. International Journal of Oral and Maxillofacial Implants, 29(Suppl), 43-54.
    1. Kloukos, D., Koukos, G., Doulis, I., Sculean, A., Stavropoulos, A., & Katsaros, C. (2018). Gingival thickness assessment at the mandibular incisors with four methods: A cross-sectional study. Journal of Periodontology, 89(11), 1300-1309.
    1. Lekholm, U., & Zarb, G. A. (1985). Patient selection and preparation. In P.-I. Branemark, G. A. Zarb, & T. Albrektsson (Eds.), Tissue integrated prostheses: Osseointegration in clinical dentistry (pp. 199-209). Quintessence Publishing Company.
    1. Leles, C. R., de Paula, M. S., Curado, T. F. F., Silva, J. R., Leles, J. L. R., McKenna, G., & Schimmel, M. (2022). Flapped versus flapless surgery and delayed versus immediate loading for a four mini implant mandibular overdenture: A RCT on post-surgical symptoms and short-term clinical outcomes. Clinical Oral Implants Research, 33(9), 953-964.
    1. Leles, C. R., Leles, J. L. R., Curado, T. F. F., Silva, J. R., Nascimento, L. N., de Paula, M. S., Maniewicz, S., Schimmel, M., & McKenna, G. (2023). The effect of mandibular bone characteristics and drilling protocols on the final insertion torque for a novel titanium-zirconium mini-implant system for overdentures: A cross-sectional analysis. Clinical Implant Dentistry and Related Research, 25, 426-434.
    1. Lemos, C. A., Verri, F. R., Batista, V. E., Júnior, J. F., Mello, C. C., & Pellizzer, E. P. (2017). Complete overdentures retained by mini implants: A systematic review. Journal of Dentistry, 57, 4-13.
    1. Mahajan, R., & Gupta, K. (2010). Adaptive design clinical trials: Methodology, challenges and prospect. Indian Journal of Pharmacology, 42(4), 201-207.
    1. Misch, C. E., Perel, M. L., Wang, H. L., Sammartino, G., Galindo-Moreno, P., Trisi, P., Steigmann, M., Rebaudi, A., Palti, A., Pikos, M. A., Schwartz-Arad, D., Choukroun, J., Gutierrez-Perez, J. L., Marenzi, G., & Valavanis, D. K. (2008). Implant success, survival, and failure: The International Congress of Oral Implantologists (ICOI) Pisa Consensus conference. Implant Dentistry, 17(1), 5-15.
    1. Mombelli, A., van Oosten, M. A., Schurch, E., Jr., & Land, N. P. (1987). The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiology and Immunology, 2(4), 145-151.
    1. Mundt, T., Schwahn, C., Stark, T., & Biffar, R. (2015). Clinical response of edentulous people treated with mini dental implants in nine dental practices. Gerodontology, 32(3), 179-187.
    1. Nüesch, E., Trelle, S., Reichenbach, S., Rutjes, A. W., Bürgi, E., Scherer, M., Altman, D. G., & Jüni, P. (2009). The effects of excluding patients from the analysis in randomized controlled trials: Meta-epidemiological study. BMJ, 339, b3244.
    1. Pallmann, P., Bedding, A. W., Choodari-Oskooei, B., Dimairo, M., Flight, L., Hampson, L. V., Holmes, J., Mander, A. P., Odondi, L., Sydes, M. R., Villar, S. S., Wason, J. M. S., Weir, C. J., Wheeler, G. M., Yap, C., & Jaki, T. (2018). Adaptive designs in clinical trials: Why use them, and how to run and report them. BMC Medicine, 16(1), 29.
    1. Park, J. H., Lee, J. Y., & Shin, S. W. (2017). Treatment outcomes for mandibular mini-implant-retained overdentures: A systematic review. International Journal of Prosthodontics, 30(3), 269-276.
    1. Prasad, S., Faverani, L. P., Santiago Junior, J. F., Sukotjo, C., & Yuan, J. C. (2022). Attachment systems for mandibular implant-supported overdentures: A systematic review and meta-analysis of randomized controlled trials. Journal of Prosthetic Dentistry, S0022-3913(22)00485-1. . Epub ahead of print.
    1. Schiegnitz, E., & Al-Nawas, B. (2018). Narrow-diameter implants: A systematic review and meta-analysis. Clinical Oral Implants Research, 29(Suppl 16), 21-40.
    1. Sculean, A., Gruber, R., & Bosshardt, D. D. (2014). Soft tissue wound healing around teeth and dental implants. Journal of Clinical Periodontology, 41(Suppl 15), S6-S22.
    1. Tabrizi, R., Behnia, H., Taherian, S., & Hesami, N. (2017). What are the incidence and factors associated with implant fracture? Journal of Oral and Maxillofacial Surgery, 75(9), 1866-1872.
    1. Tomasi, C., Idmyr, B. O., & Wennström, J. L. (2013). Patient satisfaction with mini-implant stabilised full dentures. A 1-year prospective study. Journal of Oral Rehabilitation, 40(7), 526-534.
    1. Trang, B. N. H., Kanazawa, M., Murakami, N., Wakabayashi, N., Hada, T., Sahaprom, N., Komagamine, Y., & Minakuchi, S. (2022). Stress distribution of one-piece and two-piece mini-implant overdentures with various attachment systems and diameters: A finite element analysis. Journal of Prosthodontic Research. . Epub ahead of print.
    1. Yilmaz, B., Schimmel, M., Zimmermann, P., & Janner, S. (2020). Use of a new-generation mini-implant and attachment system for fabrication of a maxillary overdenture. International Journal of Prosthodontics, 33(5), 576-581.
    1. Yin, L., Chang, Y., You, Y., Liu, C., Li, J., & Lai, H. C. (2019). Biological responses of human bone mesenchymal stem cells to Ti and TiZr implant materials. Clinical Implant Dentistry and Related Research, 21(4), 550-564.

Source: PubMed

3
Sottoscrivi