Impact of shortened dental arch on oral health-related quality of life over a period of 10 years - A randomized controlled trial.

OBJECTIVES: To compare oral health-related quality of life (OHRQoL) in patients with either molar replacement by partial removable dental prostheses (PRDP) or with restored shortened dental arches (SDA) over a period of 10 years. METHODS: In this multi-center RCT, a consecutive sample of 215 patients with bilateral molar loss in at least one jaw was initially recruited in 14 prosthodontic departments. Of those patients, 150 could be randomly allocated to the treatment groups (SDA: n = 71; PRDP: n = 79), received the allocated treatment, and were available for follow-up assessments. OHRQoL was assessed using the 49-item version of the Oral Health Impact Profile (OHIP) before treatment (baseline) and at follow-ups after treatment (4-8 weeks and 6, 12, 24, 36, 48, 60, 96, and 120 months). To investigate the course of OHRQoL over time, we longitudinally modelled treatment and time effects using mixed-effects models. RESULTS: OHRQoL substantially improved from baseline to first follow-up in both groups indicated by a mean decrease in OHIP scores of 20.0 points (95%-CI: 12.5-27.5). When compared to the SDA group, OHRQoL in the PRDP group was not significantly different (-0.6 OHIP points; 95%-CI: -7.1 to 5.9) during the study period when assuming a constant time effect. OHRQoL remained stable over the 10 years with a statistically insignificant time effect (p = 0.848). CONCLUSIONS: For patients requesting prosthodontic treatment for their lost molars, treatments with SDA or PRDP improve clinically relevantly OHRQoL and maintain it over a period of 10 years with no option being superior to the other. CLINICAL SIGNIFICANCE: Since there was no significant difference between the two treatment options over the observation period of 10 years, and since results have stayed stable over time, patients can be informed that both treatment concepts are equivalent concerning OHRQoL.

The Randomized Shortened Dental Arch study (RaSDA): design and protocol.

BACKGROUND: Various 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/DESIGN: This 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). DISCUSSION: The 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 REGISTRATION: The trial is registered at ClinicalTrials.gov under ISRCTN68590603 (pilot trial) and ISRCTN97265367 (main trial).