Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture

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  • Source:
    Journal of Advanced Prosthodontics 2013 5 2, 204 (204-8)
  • Additional Information
    • Author(s):
      Lee JY, Kim MS, Kim HY, Shin SW
    • Review Group(s):
      Handsearch register from the US Cochrane Center Trials in the Group's Specialized Register
    • Language:
      eng
    • Cochrane Study Design:
      RCT
    • Record Status:
      This record is this issue.
    • Abstract:
      PURPOSE: The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS: The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS: 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION: To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation. [By kind permission, KoreaMed, Korean Association of Medical Journal Editors.]
    • Source:
      This document should be cited as: Lee JY Kim MS Kim HY Shin SW. Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture 2013 (The Cochrane Controlled Trials Register (CCTR/CENTRAL). Oxford: Update Software. Updated quarterly.
    • Accession Number:
      CN-01045832
  • Citations
    • ABNT:
      LEE JY et al. Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture. Journal of Advanced Prosthodontics, [s. l.], v. 5, n. 2, p. 204–208, 2013. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01045832. Acesso em: 14 ago. 2020.
    • AMA:
      Lee JY, Kim MS, Kim HY, Shin SW. Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture. Journal of Advanced Prosthodontics. 2013;5(2):204-208. Accessed August 14, 2020. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01045832
    • APA:
      Lee JY, Kim MS, Kim HY, & Shin SW. (2013). Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture. Journal of Advanced Prosthodontics, 5(2), 204–208.
    • Chicago/Turabian: Author-Date:
      Lee JY, Kim MS, Kim HY, and Shin SW. 2013. “Recruitment and Enrollment in a Randomized Clinical Trial of Mandibular Two-Implant Overdenture.” Journal of Advanced Prosthodontics 5 (2): 204–8. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01045832.
    • Harvard:
      Lee JY et al. (2013) ‘Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture’, Journal of Advanced Prosthodontics, 5(2), pp. 204–208. Available at: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01045832 (Accessed: 14 August 2020).
    • Harvard: Australian:
      Lee JY, Kim MS, Kim HY & Shin SW 2013, ‘Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture’, Journal of Advanced Prosthodontics, vol. 5, no. 2, pp. 204–208, viewed 14 August 2020, .
    • MLA:
      Lee JY, et al. “Recruitment and Enrollment in a Randomized Clinical Trial of Mandibular Two-Implant Overdenture.” Journal of Advanced Prosthodontics, vol. 5, no. 2, Jan. 2013, pp. 204–208. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01045832.
    • Chicago/Turabian: Humanities:
      Lee JY, Kim MS, Kim HY, and Shin SW. “Recruitment and Enrollment in a Randomized Clinical Trial of Mandibular Two-Implant Overdenture.” Journal of Advanced Prosthodontics 5, no. 2 (January 1, 2013): 204–8. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01045832.
    • Vancouver/ICMJE:
      Lee JY, Kim MS, Kim HY, Shin SW. Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture. Journal of Advanced Prosthodontics [Internet]. 2013 Jan 1 [cited 2020 Aug 14];5(2):204–8. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01045832