Cochrane Collaboration Systematic Reviews may be based on trials not approved by a research ethics committee

Source at https://doi.org/10.1002/cre2.79 Systematic reviews (SR) may potentially contain reports of primary trials with ethical problems. The Cochrane Collaboration SRs are considered as the highest standard in evidence-based health care resources. All SRs completed during the last 5 years (2013–2017) under the management of the Oral Health Group of the Cochrane Collaboration were identified. All primary trials included in the Oral Health Group SRs were identified and examined to establish their status regarding pre-hoc approval of an independent ethics committee (EC), often termed Institutional Review Board (IRB) before commencing recruitment of trial participants. Ninety-five SRs contained 960 primary trials, of which 272 (28.3%) were not examined by the author of this paper. Amongst the remaining 688 primary trials, 198 (29%) contained no reference to study conduct approval by a research ethics committee. The majority of primary studies referred to an EC/IRB approval with or without identifying the name of the ethics committee (n = 401, 58%), whereas some papers identified both the committee name and a protocol or reference number of the EC/IRB approval (n = 89, 13%). The Cochrane Collaboration, along with other developers of SRs, should adopt the policy established by COPE with regard to what to do if one suspect an ethical problem, that is, request evidence of EC/IRB approval. All stakeholders should rest assured that clinical policies and practices based on SRs are based on ethically sound clinical research

Quo Vadis, Cochrane Collaboration?

It seems to undersigned that this initially idealistic charity has contracted some form of Icarus syndrome prompted by seduction to generate substantial revenues rather than strengthening the actual value of the offered products, i.e., the access to the databases of RCTs and systematic reviews (SR) and quality assurance of the latter category

Immediate function on the day of surgery compared with a delayed implant loading process in the mandible: A randomized clinical trial over 5 years

Objectives: To appraise the feasibility of loading four implants with a pre-existing denture converted to a fixed dental prosthesis (FDP) on the day of implant surgery compared with waiting for 3- to 4-month healing. Methods: Patients with an edentulous, fully healed mandible were recruited in a faculty clinic to partake in a blinded two-arm parallel randomized controlled trial (RCT). The participants received four parallel intraforamina mandibular implants with a moderately rough titanium surface (Brånemark System Mk III or Mk IV TiUnite; Nobel Biocare AB, Goteborg, Sweden). The implants € were loaded on the same day by converting the participants’ pre-existing denture in the experimental group. The implants were placed using a one-stage surgery procedure, and the participants’ pre-existing denture were soft-relined in the control group. For both groups, the permanent 10- to 12-unit FDP consisting of a type-3 cast precious alloy veneered with acrylic and artificial teeth was placed 3–4 months after implant surgery. All participants have been recalled annually for 5 years for appraisal of bone loss and registration of adverse events. Results: Thirty-five of the original 42 participants (83%) returned for clinical and radiological examinations at the 5-year follow-up recall. No selective dropout or specific reasons for dropout was identified in the two study arms; leaving n = 17 (Intention-to-treat group, ITT) in the experimental group, alternatively n = 13 as per protocol group (PP), and n = 18 participants in the control group (ITT = PP). At study commencement, five of the participants assigned to the experimental group did not receive their planned intervention. In the control group, one implant failed to osseointegrate and another failed due to bone loss after 5 years. The crestal bone level changes over 5 years were identical in the experimental and control groups, that is, 1.2 mm (SD = 0.7). There were no differences between the two study arms with regard to incidence of biological and technical adverse events. Conclusions: Implants in the anterior mandible loaded immediately with a converted pre-existing denture appear to yield analogous clinical outcomes compared with waiting for 3–4 months over the first 5 years following implant surgery

Group 3 ITI Consensus Report: Materials and antiresorptive drug-associated outcomes in implant dentistry

Objectives: The aim of Working Group 3 was to address the influence of both material- and anti-resorptive drug- related factors on clinical and biological outcomes and complications in implant dentistry. Focused questions were addressed on (a) implant materials other than titanium (alloy)s, (b) transmucosal abutment materials and (c) medications affecting bone metabolism were addressed. Materials and Methods: Three systematic reviews formed the basis for discussion in Group 3. Consensus statements and clinical recommendations were formulated by group consensus based on the findings of the systematic reviews. Patient perspectives and recommendations for future research were also conveyed. These were then presented and accepted following further discussion and modifications as required by the plenary. Results: Zirconia is a valid alternative to titanium as material for implant and transmucosal components, allowing soft and hard tissue integration with clinical outcomes— identified by implant survival, marginal bone loss and peri-implant probing depths—up to 5-years comparable to titatnium. However, most of the evidence for zirconia implants is based on 1-piece implants limiting the indication range. Furthermore, based on expert opinion, zirconia transmucosal components might be preferred in the esthetic zone. In patients receiving low-dose bisphosphonate therapy, the rate of early implant failure is not increased, while the long-term effects remain poorly studied. Although it has not been sufficiently addressed, similar outcomes can be expected with low-dose denosumab. A drug holiday is not recommended when considering implant placement in patients treated with low-dose ARD. However, the specific therapeutic window, the cumulative dose and the administration time should be considered. Access to peri-implant supportive care is mandatory to prevent periimplantitis-related medication-related osteonecrosis of the jaw (MRONJ) or implantrelated sequestra (IRS). In patients receiving low-dose anti-resorptive drugs (ARD) therapy, the risk of complications related to implant placement is high, and implant procedures in this specific population should be strictly treated in a comprehensive multidisciplinary center. Finally, healthy dental implants should not be removed before low or high-dose ARD. Conclusions: Zirconia implants can be an alternative to titanium implants in selected indications. However, the current state of evidence remains limited, especially for 2- piece implant designs. Administration of low-dose ARD did not show any negative impact on early implant outcomes, but careful follow-up and supportive care is recommended in order to prevent peri-implant MRONJ and IRS. Implant placement in high-dose patients must be strictly considered in a comprehensive multidisciplinary center

Fabrication, workflow and delivery of reconstruction: Summary and consensus statements of group 4. The 6th EAO Consensus Conference 2021.

Objectives: To report assessments of four systematic reviews (SRs) on (i) clinical outcomes of all-ceramic implant-supported crowns (iSCs), (ii) production time, effectiveness, and costs of computer-assisted manufacturing (CAM), (iii) computer-assisted implant planning and surgery (CAIPS) time and costs, and (iv) patient-reported outcome measures (PROMS). Material and methods: An author group consisting of experienced clinicians and content experts discussed and evaluated the SRs and formulated consensus on the main findings, statements, clinical recommendations, and need for future research. Results: All four SRs were conducted and reported according to PRISMA and detailed comprehensive search strategies in at least three bibliometric databases and hand searching. The search strategies were deemed reproducible. Variation was noted regarding language restrictions and inclusion of grey literature, but the search comprehensiveness appeared persuasive. The SRs included bias risk assessments of the primary studies, and their study methodology impacted the interpretations of the extracted data. Conclusions: (i) There is limited evidence (49 NRCT) showing that veneered and monolithic all-ceramic iSCs have excellent outcomes observed up to 3 years. (ii) There is no evidence evaluating production time and effectiveness comparing subtractive and additive CAM of implant models, abutments and crowns. (iii) There is limited evidence (4 RCT) that CAIPS involves more time and costs when considering the entire workflow and for diagnostics, manufacturing, and insertion of the restoration. Time seems to be the decisive factor for higher costs. (iv) Patients' comfort increases when optical compared to conventional impressions are used for fabricating iSCs and short-span FPDs (2 RCT, 5 NRCT)

The wonderful aspects of Open Access publishing - and the unfortunate dark side.

Published version. Source at http://doi.org/10.1002/cre2.1

The approval of clinical research by an independent ethics committee – a compulsory requirement and not a matter of the investigator's choosing

Source at https://doi.org/10.1002/cre2.92 </a

Secondary caries and microleakage

Objectives: To critically appraise experimental ex vivo research that has focused on secondary caries, and to offer possible explanations for the seemingly poor correlation to clinical observations. Methods: The literature relating to the etiopathogenesis or prevention of secondary caries gained from experimental ex vivo research was reviewed, with particular emphasis on microleakage and artificial caries-like lesions. Results: It is doubtful whether a caries wall lesion can exist independently of an outer enamel caries lesion. Microleakage experiments apparently continue to emerge regardless of multiple reviews questioning the reliability and validity of the method. Several of the approaches used to generate artificial caries-like lesions are very aggressive. Remarkably little discussion has evolved about how these aggressive approaches create microenvironments that do not occur in reality. Corrosion- and biodegradation products may influence the biofilm qualitatively and quantitatively and it is difficult to replicate these variables in any ex vivo environment. Clinical data sampling method, patient demography as well as study methodology influences the incidence and prevalence estimates of secondary caries. Clinical results based on clinical work in settings where cost per unit time is of nominal concern do not provide any indications on how the restorative material will perform when placed by the average dentists in the mouths of their spectrum of patients during a busy workday. Significance and recommendations: The term “wall lesion” including its variants is ill defined, has been, and is still being used indiscriminately. Stakeholders should avoid using this ambiguous label due to its connotation to an entity that does not exist per se