A multi-centre randomized clinical trial is under way at 14 university dental schools in Germany to compare prosthodontic treatments for the shortened dental arch (SDA). One of the aims of this pilot-study was to measure the effect of two treatment options of the SDA on oral health-related quality of life and on the Research Diagnostic Criteria (RDC) for temporomandibular disorders (TMD). Thirty-four patients participated in the pilot-study. Inclusion criteria were: all molars were missing and the presence of at least both canines and one premolar in each quadrant. Participants were randomly assigned to receive either removable partial dentures including molar replacement (RPD_group) or retain a premolar occlusion (PROC_group). The Oral Health Impact Profile (OHIP-49) and the RDC for TMD were completed by participants before treatment (pre-treatment), 6 weeks (6 wks), 6 months (6m) and 12 months (12 m) after treatment. At the 12-month follow up, data of 10 women and 11 men (mean age: 62 +/- 10 years) were available. Medians of the OHIP total-scores were as follows: RPD (n = 10), 43.5 (pre-treatment), 18.2 (6 wks), 13.3 (6m), 14.7 (12 m). PROC (n = 11): 31.8 (pre-treatment), 27.1 (6 wks), 8.8 (6m), 8.3 (12 m). Significant differences were shown for RPD_group between pre-treatment and 6m/12 m and for PROC_group between pre-treatment and 6m. There were no significant differences between treatment groups at any time. Within each group, an improvement of life-quality was observed. No significant difference could be reported between the two therapy concepts. This may be due to the low sample size within the pilot study.
The scientific evidence concerning prosthodontic care for the shortened dental arch (SDA) is sparse. This randomized multicenter study aimed to compare two common treatment options: removable partial dental prostheses (RPDPs) for molar replacement vs. no replacement (SDA). One of the hypotheses was that the follow-up treatment differs between patients with RPDPs and patients with SDAs during the 5-year follow-up period. Two hundred and fifteen patients with complete molar loss in one jaw were included in the study. Molars were either replaced by RPDPs or not replaced according to the SDA concept. A mean number of 4.2 (RPDP) and 2.8 (SDA) treatments for biological or technical reasons occurred during the 5-year observation time per patient. Concerning the biological aspect, no significant differences between the groups could be shown, whereas treatment arising from technical reasons was significantly more frequent for the RPDP group. When the severity of treatment was analyzed, a change over time was evident. When, at baseline, only follow-up treatment with minimal effort is required, over time there is a continuous increase to moderate and extensive effort observed for both groups (Controlled-trials.com number ISRCTN97265367).
BackgroundVarious treatment options for the prosthetic treatment of jaws where all molars are lost are under discussion. Besides the placement of implants, two main treatment types can be distinguished: replacement of the missing molars with removable dental prostheses and non-replacement of the molars, i.e. preservation of the shortened dental arch. Evidence is lacking regarding the long-term outcome and the clinical performance of these approaches. High treatment costs and the long time required for the treatment impede respective clinical trials.Methods/designThis 14-center randomized controlled investigator-initiated trial is ongoing. Last patient out will be in 2010. Patients over 35 years of age with all molars missing in one jaw and with at least both canines and one premolar left on each side were eligible. One group received a treatment with removable dental prostheses for molar replacement (treatment A). The other group received a treatment limited to the replacement of all missing anterior and premolar teeth using fixed bridges (treatment B). A pilot trial with 32 patients was carried out. Two hundred and fifteen patients were enrolled in the main trial where 109 patients were randomized for treatment A and 106 for treatment B. The primary outcome measure is further tooth loss during the 5-year follow-up. The secondary outcome measures encompassed clinical, technical and subjective variables. The study is funded by the Deutsche Forschungsgemeinschaft (German Research Foundation, DFG WA 831/2-1, 2-2, 2-3, 2-4, 2-5).DiscussionThe particular value of this trial is the adaptation of common design components to the very specific features of complex dental prosthetic treatments. The pilot trial proved to be indispensable because it led to a number of adjustments in the study protocol that considerably improved the practicability. The expected results are of high clinical relevance and will show the efficacy of two common treatment approaches in terms of oral health. An array of secondary outcome measures will deliver valuable supplementary information. If the results can be implemented in the clinical practice, the daily dental care should strongly profit thereof.Trial registrationThe trial is registered at ClinicalTrials.gov under ISRCTN68590603 (pilot trial) and ISRCTN97265367 (main trial).
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