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

Cláudio Rodrigues Leles, Marcella Silva de Paula, Thalita Fernandes Fleury Curado, Jésio Rodrigues Silva, José Luiz Rodrigues Leles, Gerald McKenna, Martin Schimmel, Cláudio Rodrigues Leles, Marcella Silva de Paula, Thalita Fernandes Fleury Curado, Jésio Rodrigues Silva, José Luiz Rodrigues Leles, Gerald McKenna, Martin Schimmel

Abstract

Objective: This factorial randomized clinical trial (RCT) tested the effects of the surgical approach (flapped-FPS vs. flapless-FLS surgery) and loading protocol (delayed-DL vs. immediate-IL) for treatment with a four mini implant mandibular overdenture.

Material and methods: A total of 296 one-piece titanium-zirconium mini-implants were inserted in 74 patients (IL/FLS = 17; IL/FPS = 18; DL/FLS = 20; and DL/FPS = 19). Outcomes included patient's perceived surgical burdens, clinical time, implant survival, and post-surgical symptoms and complications, assessed immediately after surgery, in the 7-day and 6-week follow-ups.

Results: Perceived surgical burdens were relatively low, higher for females, and no difference was found between FPS and FLS surgery. Surgical time was lower for FLS surgery. Overall symptoms were mild after 24 h, and higher for females. Less symptoms were recorded for the FLS surgery compared to the FPS for the delayed loading patients, and FLS surgery was associated with a lower risk of bleeding. No early implant failure was observed until the 6-week follow-up. Delayed was associated with discontinuous use of the prosthesis and poor function. Lower complaint rates were observed for immediate loading regardless of the surgery protocol.

Conclusions: Mini implants for mandibular overdenture are a feasible option regardless of surgical access and loading protocol, with high safety and predictable survival rates, and low incidence of post-insertion complications. FLS surgery requires less clinical time and results in easier intraoral prosthetic incorporation of attachments compared to FPS surgeries. Immediate loading did not increase the risk of early implant failure when satisfactory primary stability was achieved.

Keywords: clinical assessment; clinical research; clinical trials; diagnosis; patient centered outcomes; prosthodontics; wound healing.

© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

References

REFERENCES

    1. Al-Khabbaz, A. K., Griffin, T. J., & Al-Shammari, K. F. (2007). Assessment of pain associated with the surgical placement of dental implants. Journal of Periodontology, 78(2), 239-246.
    1. AlQutub, A. W. (2021). Pain experience after dental implant placement compared to tooth extraction. International Journal of Dentistry, 2021, 4134932.
    1. Bartley, E. J., & Fillingim, R. B. (2013). Sex differences in pain: A brief review of clinical and experimental findings. British Journal of Anaesthesia, 111(1), 52-58.
    1. Batisse, C., Bonnet, G., Bessadet, M., Veyrune, J. L., Hennequin, M., Peyron, M. A., & Nicolas, E. (2016). Stabilization of mandibular complete dentures by four mini implants: Impact on masticatory function. Journal of Dentistry, 50, 43-50.
    1. Batisse, C., Bonnet, G., Veyrune, J. L., Nicolas, E., & Bessadet, M. (2017). Predictive parameters of oral health quality of life in complete mandibular denture wearers stabilized by mini-implants: A two-year follow-up study. Materials (Basel), 10(10), 1197.
    1. Bidra, A. S., & Almas, K. (2013). Mini implants for definitive prosthodontic treatment: A systematic review. Journal of Prosthetic Dentistry, 109(3), 156-164.
    1. De Bruyn, H., Raes, S., Ostman, P. O., & Cosyn, J. (2014). Immediate loading in partially and completely edentulous jaws: A review of the literature with clinical guidelines. Periodontology 2000, 66(1), 153-187.
    1. De Resende, G. P., Dias, A. P., Leles, J. L. R., de Souza, J. A. C., & Leles, C. R. (2021). Postsurgical oral symptoms after insertion of one or two implants for mandibular overdentures: Short-term results of a randomized clinical trial. International Journal of Implant Dentistry, 7(1), 38.
    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. Demain, S., Gonçalves, A. C., Areia, C., Oliveira, R., Marcos, A. J., Marques, A., Parmar, R., & Hunt, K. (2015). Living with, managing and minimising treatment burden in long term conditions: A systematic review of qualitative research. PLoS One, 10(5), e0125457.
    1. Enkling, N., Haueter, M., Worni, A., Müller, F., Leles, C. R., & Schimmel, M. (2019). A prospective cohort study on survival and success of one-piece mini-implants with associated changes in oral function: Five-year outcomes. Clinical Oral Implants Research, 30(6), 570-577.
    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. Faul, F., Erdfelder, E., Buchner, A., & Lang, A. G. (2009). Statistical power analyses using G*power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41(4), 1149-1960.
    1. Fregene, T., Wintle, S., Raman, V. V., Edmond, H., & Rizvi, S. (2017). Making the experience of elective surgery better. BMJ Open Quality, 6(2), e000079.
    1. Goiato, M. C., Sônego, M. V., Pellizzer, E. P., Gomes, J. M. L., da Silva, E. V. F., & dos Santos, D. M. (2018). Clinical outcome of removable prostheses supported by mini dental implants. A systematic review. Acta Odontologica Scandinavica, 76(8), 628-637.
    1. Howell, A. M., Panesar, S. S., Burns, E. M., Donaldson, L. J., & Darzi, A. (2014). Reducing the burden of surgical harm: A systematic review of the interventions used to reduce adverse events in surgery. Annals of Surgery, 259(4), 630-641.
    1. Kanazawa, M., Feine, J., & Esfandiari, S. (2017). Clinical guidelines and procedures for provision of mandibular overdentures on 4 mini-dental implants. Journal of Prosthetic Dentistry, 117(1), 22-27.
    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. Leles, C. R., Ferreira, N. P., Vieira, A. H., Campos, A. C., & Silva, E. T. (2011). Factors influencing edentulous patients' preferences for prosthodontic treatment. Journal of Oral Rehabilitation, 38(5), 333-339.
    1. Ma, M., Qi, M., Zhang, D., & Liu, H. (2019). The clinical performance of narrow diameter implants versus regular diameter implants: A meta-analysis. The Journal of Oral Implantology, 45(6), 503-508.
    1. Marcello-Machado, R. M., Faot, F., Schuster, A. J., Nascimento, G. G., & Del Bel Cury, A. A. (2018). Mini-implants and narrow diameter implants as mandibular overdenture retainers: A systematic review and meta-analysis of clinical and radiographic outcomes. Journal of Oral Rehabilitation, 45(2), 161-183.
    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. Montgomery, A. A., Peters, T. J., & Little, P. (2003). Design, analysis and presentation of factorial randomised controlled trials. BMC Medical Research Methodology, 3, 26.
    1. Mundt, T., Passia, N., Att, W., Heydecke, G., Freitag-Wolf, S., Luthardt, R. G., Kappel, S., Konstantinidis, I. K., Stiesch, M., Wolfart, S., & Kern, M. (2017). Pain and discomfort following immediate and delayed loading by overdentures in the single mandibular implant study (SMIS). Clinical Oral Investigations, 21(2), 635-642.
    1. Myles, P. S., Weitkamp, B., Jones, K., Melick, J., & Hensen, S. (2000). Validity and reliability of a postoperative quality of recovery score: The QoR-40. British Journal of Anaesthesia, 84(1), 11-15.
    1. Oh, W. S., & Saglik, B. (2008). A simple method to duplicate a denture for an implant surgical guide. Journal of Prosthetic Dentistry, 99(4), 326-327.
    1. Pommer, B., Mailath-Pokorny, G., Haas, R., Busenlechner, D., Fürhauser, R., & Watzek, G. (2014). Patients' preferences towards minimally invasive treatment alternatives for implant rehabilitation of edentulous jaws. European Journal of Oral Implantology, 7(Suppl 2), S91-S109.
    1. Reissmann, D. R., Enkling, N., Moazzin, R., Haueter, M., Worni, A., & Schimmel, M. (2018). Long-term changes in oral health-related quality of life over a period of 5 years in patients treated with narrow diameter implants: A prospective clinical study. Journal of Dentistry, 75, 84-90.
    1. Reissmann, D. R., Poulopoulos, G., & Durham, J. (2015). Patient perceived burden of implant placement compared to surgical tooth removal and apicectomy. Journal of Dentistry, 43(12), 1456-1461.
    1. Reissmann, D. R., Semmusch, J., Farhan, D., Smeets, R., Heiland, M., & Heydecke, G. (2013). Development and validation of the burdens in Oral surgery questionnaire (BiOS-Q). Journal of Oral Rehabilitation, 40(10), 780-787.
    1. Salman, A., Thacker, S., Rubin, S., Dhingra, A., Ioannidou, E., & Schincaglia, G. P. (2019). Immediate versus delayed loading of mandibular implant-retained overdentures: A 60-month follow-up of a randomized clinical trial. Journal of Clinical Periodontology, 46(8), 863-871.
    1. Schulz, K. F., Altman, D. G., Moher, D., & CONSORT Group. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. British Medical Journal, 340, c332.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi