The outcome of a clinical trial of a dentin bonding system. Justice or injustice? 1995

N H Wilson, and M A Wilson
Department of Restorative Dentistry, University Dental Hospital, United Kingdom.

OBJECTIVE To review the findings and to question the outcome of a clinical evaluation of a dentin bonding system. METHODS The study was a split mouth, single blind (to patient), randomised within patient, clinical trial of Tripton used in conjunction with Opalux and the ultrafine compact-filled, experimental visible light cured resin composite M221784 (ICI Dental) in the restoration of mixed (enamel/dentin), caries free buccal-surface cervical lesions in vital, permanent canine and premolar teeth. The design of the trial was based on the then current American Dental Association (ADA) Clinical Protocol Guidelines for Dentin and Enamel Adhesive Materials. Restorations were placed as dictated by a predetermined randomised number scheme with each patient recruited to the study receiving at least one pair of matched restorations, comprising one restoration of each resin composite. RESULTS The study reported was discontinued at 1 year subsequent to a 17% loss rate between 6 and 12 months after placement, with most of the restorations lost having been placed in what has subsequently become shown to be relatively unfavorable situations. It is suggested that the outcome of clinical trials of the type considered may warrant review in the light of new knowledge and understanding, and that regulatory bodies setting clinical protocol guidelines must give careful consideration as to whether the criteria for this type of trial should be more restrictive or required to include a representative range of clinically relevant situations.

UI MeSH Term Description Entries
D008297 Male Males
D008689 Methacrylates Acrylic acids or acrylates which are substituted in the C-2 position with a methyl group. Methacrylate
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011140 Polyurethanes A group of thermoplastic or thermosetting polymers containing polyisocyanate. They are used as ELASTOMERS, as coatings, as fibers and as foams. Polyisocyanates,Ostamer,Pellethane,Spandex,Ostamers,Pellethanes,Polyisocyanate,Polyurethane,Spandices
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003188 Composite Resins Synthetic resins, containing an inert filler, that are widely used in dentistry. Composite Resin,Resin, Composite,Resins, Composite
D003481 Cuspid The third tooth to the left and to the right of the midline of either jaw, situated between the second INCISOR and the premolar teeth (BICUSPID). (Jablonski, Dictionary of Dentistry, 1992, p817) Canine Tooth,Canine Teeth,Cuspids,Teeth, Canine,Tooth, Canine
D003793 Dental Restoration, Permanent A restoration designed to remain in service for not less than 20 to 30 years, usually made of gold casting, cohesive gold, or amalgam. (Jablonski, Dictionary of Dentistry, 1992) Dental Fillings, Permanent,Dental Filling, Permanent,Dental Permanent Filling,Dental Permanent Fillings,Dental Restorations, Permanent,Filling, Dental Permanent,Filling, Permanent Dental,Fillings, Dental Permanent,Fillings, Permanent Dental,Permanent Dental Filling,Permanent Dental Fillings,Permanent Dental Restoration,Permanent Dental Restorations,Permanent Filling, Dental,Permanent Fillings, Dental,Restoration, Permanent Dental,Restorations, Permanent Dental
D004990 Ethics, Dental The principles of proper professional conduct concerning the rights and duties of the dentist, relations with patients and fellow practitioners, as well as actions of the dentist in patient care and interpersonal relations with patient families. (From Stedman, 25th ed) Dental Ethics,Dental Ethic,Ethic, Dental
D005260 Female Females

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