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BackgroundMost orthodontic treatment plans need some form of anchorage to control the reciprocal forces of tooth movement. Orthodontic mini implants (OMIs) have been hailed for having revolutionized orthodontics, because they provide anchorage without depending on the collaboration of patients, they have a favorable effectiveness compared with conventional anchorage devices, and they can be used for a wide scale of treatment objectives. However, surveys have shown that many orthodontists never or rarely use them. To understand the rationale behind this knowledge-to-action gap, we will conduct a systematic review that will identify and quantify potential barriers and facilitators to the implementation of OMIs in clinical practice for all potential stakeholders, i.e., patients, family members, clinicians, office staff, clinic owners, policy makers, etc. The prevalence of clinicians that do not use OMIs will be our secondary outcome.MethodsThe Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015 Statement was adopted as the framework for reporting this manuscript. We will apply broad-spectrum search strategies and will search MEDLINE and more than 40 other databases. We will conduct searches in the gray literature, screen reference lists, and hand-search 12 journals. All study designs, stakeholders, interventions, settings, and languages will be eligible. We will search studies that report on barriers or facilitators to the implementation of orthodontic mini implants (OMIs) in clinical practice. Implementation constructs and their prevalence among pertinent stakeholders will be our primary outcomes. All searching and data extraction procedures will be conducted by three experienced reviewers. We will also contact authors and investigators to obtain additional information on data items and unidentified studies. Risk of bias will be scored with tools designed for the specific study designs. We will assess heterogeneity, meta-biases, and the robustness of the overall evidence of outcomes. We will present findings in a systematic narrative synthesis and plan meta-analyses when pertinent criteria are met.DiscussionKnowledge creation on this research topic could identify and quantify both expected and unexpected implementation constructs and their stakeholders. Such knowledge can help develop strategies to address implementation issues and redirect future studies on OMIs towards knowledge translation. This could lead to improved patient-health experiences and a reduction in research waste.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0198-4) contains supplementary material, which is available to authorized users.

BackgroundHitting a dental root during the insertion of orthodontic mini-implants (OMIs) is a common adverse effect of this intervention. This condition can permanently damage these structures and can cause implant instability. Increased torque levels (index test) recorded during the insertion of OMIs may provide a more accurate and immediate diagnosis of implant-root contact (target condition) than radiographic imaging (reference standard). An accurate index test could reduce or eliminate X-ray exposure. These issues, the common use of OMIs, the high prevalence of the target condition, and because most OMIs are placed between roots warrant a systematic review. We will assess 1) the diagnostic accuracy and the adverse effects of the index test, 2) whether OMIs with root contact have higher insertion torque values than those without, and 3) whether intermediate torque values have clinical diagnostic utility.MethodsThe Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015 statement was used as a the guideline for reporting this protocol. Inserting implants deliberately into dental roots of human participants would not be approved by ethical review boards and adverse effects of interventions are generally underreported. We will therefore apply broad spectrum eligibility criteria, which will include clinical, animal and cadaver models. Not including these models could slow down knowledge translation.Both randomized and non-randomized research studies will be included. Comparisons of interest and subgroups are pre-specified. We will conduct searches in MEDLINE and more than 40 other electronic databases. We will search the grey literature and reference lists and hand-search ten journals. All methodological procedures will be conducted by three reviewers. Study selection, data extraction and analyses, and protocols for contacting authors and resolving conflicts between reviewers are described. Designed specific risk of bias tools will be tailored to the research question. Different research models will be analysed separately. Parameters for exploring statistical heterogeneity and conducting meta-analyses are pre-specified. The quality of evidence for outcomes will be assessed through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.DiscussionThe findings of this systematic review will be useful for patients, clinicians, researchers, guideline developers, policymakers, and surgical companies.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-015-0014-6) contains supplementary material, which is available to authorized users.

BackgroundSynthesizing outcomes of underreported primary studies can pose a serious threat to the validity of outcomes and conclusions of systematic reviews. To address this problem, the Cochrane Collaboration recommends reviewers to contact authors of eligible primary studies to obtain additional information on poorly reported items. In this protocol, we present a cross-sectional study and a survey to assess (1) how reviewers of new Cochrane intervention reviews report on procedures and outcomes of contacting of authors of primary studies to obtain additional data, (2) how authors reply, and (3) the consequences of these additional data on the outcomes and quality scores in the review. All research questions and methods were pilot tested on 2 months of Cochrane reviews and were subsequently fine-tuned.Methods for the cross-sectional studyEligibility criteria are (1) all new (not-updates) Cochrane intervention reviews published in 2016, (2) reviews that included one or more primary studies, and (3) eligible interventions refer to contacting of authors of the eligible primary studies included in the review to obtain additional research data (e.g., information on unreported or missing data, individual patient data, research methods, and bias issues). Searching for eligible reviews and data extraction will be conducted by two authors independently. The cross-sectional study will primarily focus on how contacting of authors is conducted and reported, how contacted authors reply, and how reviewers report on obtained additional data and their consequences for the review.Methods for the surveyThe same eligible reviews for the cross-sectional study will also be eligible for the survey. Surveys will be sent to the contact addresses of these reviews according to a pre-defined protocol. We will use Google Forms as our survey platform. Surveyees are asked to answer eight questions. The survey will primarily focus on the consequences of contacting authors of eligible primary studies for the risk of bias and Grading of Recommendations, Assessment, Development and Evaluation scores and the primary and secondary outcomes of the review.DiscussionThe findings of this study could help improve methods of contacting authors and reporting of these procedures and their outcomes. Patients, clinicians, researchers, guideline developers, research sponsors, and the general public will all be beneficiaries.Electronic supplementary materialThe online version of this article (10.1186/s13643-017-0643-z) contains supplementary material, which is available to authorized users.

This article systematically reviewed the literature to (1) identify variables that were associated with maximum insertion torque values during the insertion of orthodontic mini-implants into artificial bone, (2) quantify such associations and (3) assess adverse effects of this procedure. Computerized and manual searches were conducted up to 24 February 2012. Selection criteria included studies that (1) recorded maximum insertion torque during the insertion of orthodontic mini-implants into artificial bone, (2) used sample sizes of five screws or more, (3) assessed maximum insertion torque with electronic torque sensors, and (4) used orthodontic mini-implants with a diameter smaller than 2.5 mm. ASTM Standards F543-07(ε1) and F1839-08(ε1) and the Cochrane Handbook for Systematic Reviews were used as guidelines for this systematic review. Quality assessments were rated according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. A total of 23 studies were selected, many of which were multiple publications of the same study. Many domains in the risk of bias assessments were scored as "high" or "unclear" risk of bias. A wide variety of implant, test block, and insertion procedure-related associations with maximum insertion torque were recorded. The quality of most outcomes was classified as "moderate." Outcomes could not be combined in a meta-analysis because of high risk of bias, poor standardization, high heterogeneity, or inconsistency in direction of outcomes within or between studies. Adverse effects were only assessed in one study. Future studies should control publication bias, consult existing standards for conducting torque tests, and focus on transparent reporting.

BackgroundMost orthodontic mini-implants (OMIs) are inserted between dental roots. The prevalence of contacting these structures is high. Such contacts can cause permanent root damage and implant instability. Increased torque levels during implant insertion (the index test) could be a more accurate and immediate measure for diagnosing implant-root contact (the target condition) than radiographs (the reference standard) and could ultimately lead to a reduction or elimination of X-ray exposure. To address this issue, we asked three questions: (1) whether OMIs with root contact had higher insertion torque values than those without, (2) what is the accuracy of the index test compared with the reference standard to diagnose the target condition and what are the adverse effects of the index test, and (3) whether intermediate torque values have clinical diagnostic utility.MethodsMethods were conducted according to our published protocol, which was based on the PRISMA-P 2015 statement. We applied broad spectrum eligibility criteria that included randomized and non-randomized studies on clinical, animal, and cadaver models. Not including such models would be unethical because it could slow down knowledge creation on the adverse effects of implant insertion. We conducted searches in more than 40 electronic databases including MEDLINE and 10 journals were hand-searched. Grey literature and reference lists were also searched. All research procedures were conducted independently by three reviewers. Authors of selected studies were contacted to obtain additional information. Outcomes on the three different research models were analysed separately. Systematic error was assessed with the Cochrane ‘Risk of bias tool’ for non-randomized studies.ResultsOne clinical, two animal, and two cadaver studies fulfilled the eligibility criteria of the first research question. All studies and subgroups demonstrated higher insertion torque values for OMIs with the target condition than those without. Mean differences (MD) between these effect estimates were statistically significant in one beagle model (MD, 4.64; 95 % CI, 3.50 to 5.79) and three subgroups of cadaver studies (MD, 2.70; 95 % CI, 1.42 to 3.98) (MD, 3.97; 95 % CI, 2.17 to 5.78) (MD, 0.93; 95 % CI, 0.67 to 1.20). Highest mean differences were identified in most self-drilling compared with pre-drilling groups. Clinical heterogeneity between studies was high, and many items were underreported. All studies except one cadaver study scored at least one domain as ‘serious risk’ of bias. No studies addressed the second research question. One cadaver study addressed the third question which showed the importance of recording torque levels during the entire implant insertion process. Responses of contacted authors were helpful, but often difficult to obtain. Implants fractured in one animal and in one cadaver model.ConclusionsAll eligible studies scored higher insertion torque values for implants with root contact than those without, but none of these studies assessed the diagnostic accura...

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Data sourcesPubmed, Embase, Cochrane Central Register of Controlled Trials and the Web of Science databases. Hand searches of the journals European Journal of Orthodontics, Journal of Orthodontics, Journal of Clinical Orthodontics, Seminars in Orthodontics, American Journal of Orthodontics & Dentofacial Orthopaedics and Angle Orthodontist.Study selectionTwo reviewers independently selected studies. Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of orthodontic patients requiring extraction of the maxillary first premolars and closure of the spaces without anchorage loss were considered.Data extraction and synthesisData extraction and risk of bias assessment were carried out independently by two reviewers. Meta-analysis and sensitivity analysis were conducted.ResultsFourteen studies; seven RCTS and seven CCTs were included. In total 303 patients received TISADs with 313 control patients. Overall the quality of the studies was considered to be moderate. Overall the TISAD group had significantly less anchorage loss than the control group. On average, TISADs enabled 1.86mm more anchorage preservation than did conventional methods.ConclusionsThe results of the meta-analysis showed that TISADs are more effective than conventional methods of anchorage reinforcement. The average difference of 2mm seems not only statistically but also clinically significant. However, the results should be interpreted with caution because of the moderate quality of the included studies. More high-quality studies on this issue are necessary to enable drawing more reliable conclusions.