Overview of ethical issues in clinical studies.

Research in human subjects should be conducted only if the rights and welfare of the participants are protected. Prospective study subjects must be given adequate information about all aspects of a study so that they can make a rationally exercised decision about participation; coercive techniques to solicit participants should not be used. Research in humans may be classified in one of three categories: A. Research on treatment of existing conditions; B. Research on preventive measures; and C. Research other than for treatment or prevention. Different concerns and aspects of informed consent assume particular importance in each category. In research on the treatment of existing conditions, untreated or placebo-treated control groups are rarely justified if the condition is irreversible. In research on preventive methods prospective subjects should be informed of the likelihood of receiving an ineffective treatment, if one or more placebo groups are included. A randomized clinical trial is usually the best design for studies of preventive methods. Nonrandomized designs, that are feasible and statistically valid, may be employed in order to avoid depriving some subjects from receiving effective preventive methods. In social or behavioral research, confidentiality of collected information and privacy of the subject are essential considerations.     

The ethical and practical aspects of acceptance and universal patient acceptance

"Acceptance" is an often presupposed, hidden core value and ethic focused on how dental and other health practitioners first accept people as possible patients. The three basic styles of patient acceptance are random, selective, and universal. Reduced public access to care results from the practice of random and selective acceptance. Only universal acceptance creates a potential pathway for improved access to care. The notion of Universal Patient Acceptance (UPA) is discussed here as one kind of applied ethical tool or clinical practice that allows for the ethic of acceptance to be more effectively pursued in daily practice. We suggest that health providers falsely surmise that they already understand and practice Universal Patient Acceptance. That myth and perspective are partly what keeps Acceptance hidden as an ethic and overlooked as a potential way to foster dialogue and indirectly promote better access to care. Without Universal Patient Acceptance, dental and health providers will continue to silently engage in practice patterns that adversely affect public access to care. The actual benefits of Universal Patient Acceptance are the subject of ongoing review and debate. Whatever those benefits might be will not likely be realized until Acceptance and Universal Patient Acceptance are included as part of dental and other health professional codes of ethics and training curricula. That is what we argue for here.     

Endodontic diagnosis: clinical aspects

The objectives of this article are to review classic and current concepts on endodontic diagnosis, to describe the current classification of the pulp and periradicular diseases and to present and discuss the diagnostic tools available for endodontic diagnosis. The "SOAP" approach to endodontic diagnosis is a very efficient and simple method to accomplish accurate diagnosis. SOAP serves as a mnemonic to guide the clinician in data collection and stands for: Subjective, Objective, Assessment, and Plan.     

Etiopathogenic and clinical aspects of asymmetry

Complex dysmorphies, asymmetries can affect the various elements of the stomatognathic system: cranial base, maxilla, mandible, musculature and dental arches, in the three dimensions of space. Their etiopathogenesis, as well as their clinical forms, vary considerably. Dysembryopathies, growth disorders, TMJ damages, postural or functional disorders and dental anomalies can create, according to their severity and their moment of appearance, severe or minor facial asymmetries, or asymmetries of the arches. An exo- and endobuccal clinical examination endeavors to specify the localization and the severity of the damage, and to evaluate the importance of the possible alveolar compensations. Consolidated by additional examinations, it enables the clinician to differentiate the various forms of asymmetries.     

A controlled clinical trial of implant-retained mandibular overdentures: clinical aspects

summary In a controlled clinical trial, treatment effects of mandibular overdentures on two different implant-systems in edentulous patients were compared one year after insertion of the new dentures. The implant-systems used were the Brånemark system (Brå) and the IMZ-system. Treatment was randomly assigned to 60 patients according to a balanced allocation method. Evaluation included peri-implant and radiographical parameters. According to the Delphi method a clinical implant performance scale (CIP) was constructed based on all conceivable complications of the different implant systems. During the osseointegration period, five Brå- and one IMZ-implants were lost. The results of one of the peri-implant parameters and the radiographical score showed significant differences considering the (pseudo) pocket probing depth (Brå better than IMZ, P < 0.001) and the radiographic-score (IMZ better than Brå, P < 0003). The results for the CIP-scale were less favourable for the Brå-group than for the IMZ-group; however, these differences were not significant.     

Knowledge of ethical lapses and other experiences on clinical licensure examinations.

While clinical licensure examinations claim to protect the public from incompetent practitioners, serious problems related to issues of validity, reliability, and ethics have been reported. The ethical lapses are difficult to document, and reports of problems have been strictly anecdotal. This study's primary purpose was to verify those anecdotal reports by mailing a twenty-one-item survey to a national random sample of one thousand general dentists who graduated from a United States-accredited dental school between 1980 and 1994. For those who responded (42.9 percent) results show that 23.9 percent did not arrange for follow-up care for the patient even though it was indicated. Eight percent reported knowledge of instances where a lesion was intentionally created; 19.3 percent knew of premature treatment provided for purposes of the examination; 13.7 percent knew of a colleague who coerced a patient into accepting treatment; 32.5 percent reported knowledge of unnecessary radiographs. About half of all respondents agreed that the examination was not an accurate assessment of ability, and a similar proportion doubted that human patients were necessary. A more reliable and valid assessment strategy that does not jeopardize patient care is needed.     

Designing hypersensitivity clinical studies

A dentinal hypersensitivity study is really a clinical pain study. The fundamental difficulties in reproducibly and reliably measuring pain impact heavily on the study. Other critical issues include investigator and subject selection, study design, randomization strategy, study duration, sample size, and statistical analysis. This article discusses principles involved in establishing the efficacy of a desensitizing agent.     

Ceramic inlay systems: some clinical aspects

summary Due to their inertness and unsurpassed aesthetic properties, ceramic materials are increasingly used as inlay materials. Based on a questionnaire, the frequency and character of complications related to ceramic inlay therapy were assessed and some important pitfalls and clinical relevant factors discussed. A majority of the dentists performed between 1 and 10 ceramic inlays per month using several different ceramic materials. As many as 85% of the dentists had observed complications in connection with ceramic inlays. Most frequency reported was hypersensitivity of a transient nature (15%). The material revealed an overall inlay fracture frequency of 5%, but the individual variations were high. Tooth fracture, loss of retention and other complications such as secondary caries, endodontic envolvement, colour mismatch and a surface and edge deterioration occurred with a varying but lower frequency. Failure analysis revealed a large number of causative factors among which cavity and inlay design, bonding procedures, selection of luting material and proper case selection were regarded as the most important. Due consideration to the strength of remaining tooth substance was found to be important in reducing the problem of hypersensitivity and the risk of tooth and inlay fracture.