Abstract
BackgroundIn 2009, we began recruiting dental practitioners across Germany to participate in a clinical trial to evaluate the clinical performance of EQUIA, a new glass ionomer restoration material. The aim of this paper is to discuss the outcomes of the dental practitioner recruitment and outline the process of establishing a practice-based research network.MethodsStudy proposals were sent to randomly selected dental offices in 29 cities in Germany. The proposals were sent until a minimum of 10 clinics in each city declared participation. Later on, briefing lectures informed the participating practitioners about the design, methods, and material application procedure. Participants were familiarized with the guidelines of Good Manufacturing Practice (GMP) and Good Epidemiological Practice (GEP). A questionnaire describing the characteristics of each dental office was filled out by the participating practitioner. Additionally, participation levels were characterized according to the socioeconomic status and geographic districts of residence in Germany (Regions 0 to 9). The associations between the characteristics were tested by the Kruskal-Wallis Test and Chi-squared test (P < 0.05).ResultsA total of 3194 private dental clinics were invited, 1712 clinics refused to participate, 1195 did not respond to the invitation, and 323 agreed to participate. Only 144 clinics participated in the lectures held in their cities and signed the participation agreement. Based on their geographic location, the highest participation was in Region 2 with a participation rate of 14.3 %, and the lowest participation was in Region 6 with a participation rate of 1.7 %. Regions with the lowest rate of unemployment and relatively higher rates of income (Regions 7 and 8) had the highest rate of refusals (86 %).ConclusionThe initial results of the dental practitioner recruitment in this study suggest that the recruitment and pre-randomization design were successful, and by reaching out to a considerable number of private dental clinics to participate, we were able to recruit a smaller number of highly motivated dentists in this clinical study. Regional differences in socioeconomic status, practitioner specialization, and differences in patient health care insurance have to be considered when recruiting dental practitioners for clinical trials.Trial registrationThe trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) on 6 September 2012 under DRKS-ID: DRKS00004220.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1198-3) contains supplementary material, which is available to authorized users.
Highlights
In 2009, we began recruiting dental practitioners across Germany to participate in a clinical trial to evaluate the clinical performance of EQUIA, a new glass ionomer restoration material
A double-blinded, randomized, prospective clinical trial in the field was primarily designed to assess the clinical performance of two variants of a commonly used dental material promoted as an alternative filling material to amalgam and composite in posterior teeth
Regions with the lowest rate of unemployment and relatively higher rates of income (Regions 7 and 8) had the highest rate of refusals (86 %) in trial participation (Table 2)
Summary
In 2009, we began recruiting dental practitioners across Germany to participate in a clinical trial to evaluate the clinical performance of EQUIA, a new glass ionomer restoration material. Randomized clinical trials (RCTs) are widely recognized for providing important scientific evidence on the efficacy and safety of new therapies, materials, and techniques in the dental field. Researchers need to design clinical trials to demonstrate differences between newer therapies or materials and existing ones. A clinical trial might have either a prospective or a retrospective design. Whereas the data or the outcome of interest has already been collected at the start of a retrospective study, and important data often may not be available, a prospective study design would allow collection of data at regular time intervals and follows the outcome of interest in a forward direction. The required large sample sizes and potential losses to follow-up can present further problems in prospective studies and create substantial difficulties compared to other types of analytical studies
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