HOW TO IDENTIFY SUBGROUPS IN LONGITUDINAL CLINICAL DATA: TREATMENT RESPONSE PATTERNS IN PATIENTS WITH A SHORTENED DENTAL ARCH.

BACKGROUND: When dental patients seek care, treatments are not always successful,that is patients' oral health problems are not always eliminated or substantially reduced. Identifying these patients (treatment non-responders) is essential for clinical decision-making. Group-based trajectory modeling (GBTM) is rarely used in dentistry, but a promising statistical technique to identify non-responders in particular and clinical distinct patient groups in general in longitudinal data sets. AIM: Using group-based trajectory modeling, this study aimed to demonstrate how to identify oral health-related quality of life (OHRQoL) treatment response patterns by the example of patients with a shortened dental arch (SDA). METHODS: This paper is a secondary data analysis of a randomized controlled clinical trial. In this trial SDA patients received partial removable dental prostheses replacing missing teeth up to the first molars (N = 79) either or the dental arch ended with the second premolar that was present or replaced by a cantilever fixed dental prosthesis (N = 71). Up to ten follow-up examinations (1-2, 6, 12, 24, 36, 48, 60, 96, 120, and 180 months post-treatment) continued for 15 years. The outcome OHRQoL was assessed with the 49-item Oral Health Impact Profile (OHIP). Exploratory GBTM was performed to identify treatment response patterns. RESULTS: Two response patterns could be identified - "responders" and "non-responders." Responders' OHRQoL improved substantially and stayed primarily stable over the 15 years. Non-responders' OHRQoL did not improve considerably over time or worsened. While the SDA treatments were not related to the 2 response patterns, higher levels of functional, pain-related, psychological impairment in particular, and severely impaired OHRQoL in general predicted a non-responding OHRQoL pattern after treatment. Supplementary, a 3 pattern approach has been evaluated. CONCLUSIONS: Clustering patients according to certain longitudinal characteristics after treatment is generally important, but specifically identifying treatment in non-responders is central. With the increasing availability of OHRQoL data in clinical research and regular patient care, GBTM has become a powerful tool to investigate which dental treatment works for which patients.

IMPACT OF SHORTENED DENTAL ARCH ON ORAL HEALTH-RELATED QUALITY OF LIFE.

BACKGROUND: A shortened dental arch (SDA) is an established treatment concept for patients with missing molars. However, little is known regarding long-term course of oral health-related quality of life (OHRQoL) in patients with SDA and the benefits from replacement of missing molars. OBJECTIVE: Purpose of this multi-center randomized clinical trial was to assess OHRQoL over a period of 15 years in patients with molar replacement by a removable partial denture (RPD) compared to patients with a restored SDA without molar replacement. METHODS: Patients at least 35 years of age with all molars missing in 1 jaw and at least the canine and one premolar present on each side were included. Patients received either a precision attachment-retained, RPD for replacement of missing molars (n = 79), or the dental arch ended with the second premolar (SDA) that had to be present or replaced by a cantilever fixed dental prosthesis (n = 71). Follow-up examinations continued for 15 years. OHRQoL was assessed with the 49-item Oral Health Impact Profile (OHIP). OHIP summary and dimension scores were longitudinally modeled in the statistical analyses to assess course of OHRQoL over time applying an intention-to-treat approach. In addition, scores for the OHRQoL dimensions Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact were analyzed. RESULTS: After an initial improvement in OHRQoL indicated by a mean decrease of 20.0 OHIP points with an effect size of 0.61 in the entire study population, OHRQoL stayed relatively constant over the entire follow-up period. Assuming a constant time and treatment effects over the study period, OHRQoL did not differ statistically significant between the 2 treatments (0.4 OHIP points; 95%-CI: 7.1 - 6.2). OHRQoL after treatment did not change notably over 15 years and was statistically nonsignificant as well (P = .872). Similar findings were observed in all 4 OHRQoL dimensions. CONCLUSIONS: In patients, missing all molars in one jaw OHRQoL improved providing RPD or restoring SDA to a clinically relevant degree. Treatment-related improvement remained mostly stable over a period of at least 15 years. Therefore, patients can be informed that both treatment concepts are equivalent concerning long-term OHRQoL. Accordingly, patients' preferences regarding treatment options should be granted priority in treatment decision making with the SDA treatment option being the default.

Rehabilitation of shortened dental arches: A fifteen-year randomised trial.

BACKGROUND: Few long-term studies on treatments in the shortened dental arch (SDA) are available. OBJECTIVE: The objective of this trial was to analyse the long-term success of two different treatment concepts. METHODS: Patients over 35 years of age with missing molars in one jaw and at least the canine and one premolar present on both sides were eligible. In the partial removable dental prosthesis (PRDP) group (N = 81), molars and missing second premolars were replaced by a precision attachment retained prosthesis. In the SDA group (N = 71), the dental arch ended with the second premolar that had to be present or replaced by a cantilever fixed dental prosthesis. Follow-up examinations were carried out over 15 years. RESULTS: A comprehensive outcome variable comprised four failure categories for which Kaplan-Meier survival (success) analyses were conducted. Half of the patients exhibited a continuous preservation of the per protocol prosthetic status that remained totally unaffected by complications for more than 10 years. The event-free success rates for moderate or worse failure implied a loss of the per protocol prosthetic status. The respective survival rates fell below 50% at 14.2 years in the PRDP group and 14.3 years in the SDA group. In none of the analyses, a significant group difference was found. CONCLUSIONS: In patients with an SDA condition, changes in the prosthetic status have to be expected. The affected proportion increases almost linearly from shortly after treatment and comprises the majority after 15 years. The influence of the examined treatments on success appears to be low.

Periodontal health in shortened dental arches: A 10-year RCT.

PURPOSE: This analysis focused on periodontal health in shortened dental arches (SDAs). METHODS: In a randomized controlled clinical trial, patients with missing molars in one jaw and at least one premolar and canine on both sides were eligible for participation. In the partial removable dental prosthesis (PRDP) group (n = 79), molars were replaced with a precision attachment retained PRDP. In the SDA group (n == 71), the SDA up to the second premolars was either left as is or restored with fixed dental prostheses. Outcome variables were vertical clinical attachment loss (CAL-V), pocket probing depth (PPD), bleeding on probing (BOP) and plaque index (PLI). For CAL-V and PPD, the changes at six measuring points per tooth were analyzed. For BOP and PLI, patient related rates were calculated for each point in time. Statistical methods included linear regression analyses. RESULTS: In the intention-to-treat (ITT) analysis for CAL-V in the study jaw, the 10 year patient related mean changes were 0.66 mm in the PRDP group and -0.13 mm in the SDA group. The resulting mean patient related group difference of 0.79 mm (95% CI: 0.20 mm-1.38 mm) was significant (p = 0.01). There were no significant differences in the ITT analyses for PPD. For BOP and PLI, significant group differences with more favorable results for the SDA group were found. CONCLUSIONS: In view of lacking substantial differences for CAL-V and PPD, the overall differences were considered of minor clinical relevance. The results add confirmatory evidence to the shortened dental arch concept and its clinical viability (controlled-trials.com ISRCTN97265367).

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: Tooth Loss Over 10 Years.

PURPOSE: This study aimed to compare the long-term outcomes of two different nonimplant treatments in the bilateral shortened dental arch (SDA). MATERIALS AND METHODS: In a multicenter randomized controlled clinical trial, patients with complete molar loss in one arch were assigned to one of two different nonimplant treatments. In the partial removable dental prosthesis (PRDP) group, patients were provided with a distal-extension prosthesis retained with precision attachments. In the SDA group, patients were treated according to the SDA concept by preserving or restoring a premolar occlusion. RESULTS: Of the 152 treated patients, 82 reached the 10-year examination independent of their dental or prosthetic status. In the intention-to-treat analysis, the survival rates for tooth loss at 10 years were 0.44 (95% confidence interval [CI]: 0.30 to 0.56) in the PRDP group and 0.52 (95% CI: 0.37 to 0.65) in the SDA group. For tooth loss in the study arch, the survival rates were 0.67 (95% CI: 0.52 to 0.78) in the PRDP group and 0.60 (95% CI: 0.45 to 0.73) in the SDA group. The number of teeth lost was higher than expected. In a multivariate analysis using a multiple Cox regression model, the covariates age (unit: 1 year, Hazard Ratio [HR]: 1.033, P = .03) and DMFT value (unit: 1 tooth, HR: 1.121, P = .03) were significant for time to first tooth loss in the study arch. CONCLUSION: The results suggest an overestimation of the influence of the prosthetic management of the bilateral SDA. In treatment decisions, patient preferences should be considered with appropriate weight.

The randomized shortened dental arch study: influence of two different treatments on interdental spacing over 5 years.

OBJECTIVES: Being a secondary outcome in a multicenter randomized controlled trial, the present analysis focused on interdental spacing in the shortened dental arch (SDA). The aim was to evaluate changes in interdental spacing in dependence of two different treatments after an observation period of up to 5 years. MATERIAL AND METHODS: Patients were either treated with a partial removable dental prosthesis (PRDP) for molar replacement (PRDP group) or according to the SDA concept aiming at a premolar occlusion (SDA group) in a randomized manner. Interdental spacing in the anterior region was measured with gauges and categorized as "0" (<0.1 mm), "1" (<0.5 mm), "2" (0.5-1 mm), and "3" (>1 mm). The statistical analysis was performed with analysis of variance models followed by linear contrast. RESULTS: Ninety-one patients (SDA n = 41, PRDP n = 50) were included. Changes of interdental spacing were detected in 70.7 % of all cases. A significant difference between the mean score changes was found in the mandible comparing the PRDP group and the SDA group. The respective mean score changes from baseline to 5 years were 0.23 (SD 0.49) for the PRDP group and 0.02 (SD 0.30) for the SDA group (p = 0.023). CONCLUSIONS: Major interdental spacing could be observed in neither of the groups. The SDA concept resulted in a slightly better outcome. CLINICAL RELEVANCE: When deciding whether to replace missing molars, the present results give further support to the SDA concept.

Process-based approach to modeling recurrent-event data explicated on the basis of occurrences of tooth losses in two different prosthetic treatment concepts.

BACKGROUND: In studies comparing different prosthetic treatment concepts the repeated loss of teeth was chosen as the primary outcome. The resulting data appear to represent a data structure of recurrent events. However, the application of an existing method for recurrent events is far from straightforward. Often only the first event or the final state is analyzed using Kaplan-Meier survival statistics, thereby giving a great deal of information away. METHODS: The paper presents a strategy for the analysis of recurrent data using a previously published study on the influence of different prosthetic treatment concepts for the shortened dental arch on tooth loss. A method based on cumulative sample history functions of recurrent events was adjusted for tooth loss. The shapes of these cumulative functions suggest a time dependency of the recurrence rate. To keep the model as simple as possible, a tripartite Poisson process (which assumes piecewise time-independent rates) was fitted to the cumulative mean functions stratified by treatment. RESULTS: Within the middle interval of the three-phasic process, the treatment effects differ significantly, which is interpreted as a delay of tooth loss due to the use of one type of prosthesis (fixed) compared with the other (removable). CONCLUSIONS: An analysis based on cumulative history functions is based on process, therefore, temporally changing characteristics are better captured than in methods for survival analyses. The presented approach offers useful new insight into the temporal behavior of ongoing tooth loss after prosthetic treatment. TRIAL REGISTRATION: The trial has been registered at controlled-trials.com under ISRCTN97265367 (registration date 4 April 2008).

Posterior alveolar ridge resorption in bar-retained mandibular overdentures: 10-year results of a prospective clinical trial.

OBJECTIVES: Data on posterior alveolar ridge resorption (PARR) in patients with two implant supported mandibular overdentures is very heterogeneous. The aim of this prospective study was to observe the PARR after ten years for a study population treated with a titanium bar retained overdenture on two IMZ-implants. MATERIAL AND METHODS: The data pool consisted of digital and digitized conventional panoramic radiographs taken prior to implant placement and at follow up appointments. Digital measurements were carried out following an established procedure ("Tuebingen method" by Gomez-Roman). For each patient a linear regression was calculated resulting in a relative area related PARR-value per year. A simplified geometrical scenario was used for the estimation of absolute bone height losses. RESULTS: Data of 23 patients was available. The mean observation period was 9.4 years (±2.4 years). An average area related PARR-rate of 1.02% per year was observed with high individual differences ranging from 0.15% and 2.63% per year. The estimated average ten year vertical bone loss in the chewing center was 1.5 mm. CONCLUSIONS: Posterior bone resorption was found to be in the range previously reported for different implant restorations and therefore does not represent a particular problem of two implant bar retained overdentures. The results strengthen the two implant concept.

Clinical performance of cantilevered fixed dental prostheses abutments in the shortened dental arch.

OBJECTIVES: This article is part of a randomized clinical trial on different treatments in the shortened dental arch (SDA). It focused on the abutment tooth prognosis with cantilevered fixed dental prostheses (CFDPs). METHODS: Sixty-two patients with a bilaterally SDA up to the first or second premolar in the mandible or maxilla were evaluated. In 57 of 124 quadrants, second premolars were replaced by a CFDP (cantilever group). In the remaining 67 quadrants, a natural second premolar was present and thus no need for a CFDP was given (non-cantilever group). Patients were recalled annually up to 5 years. RESULTS: The mean observation period was 56.3 months (min. 3.0, max. 76.2, SD 16.1). Kaplan-Meier survival rates concerning tooth loss and tooth fracture were 93.9%/94.0% in the cantilever group and 91.9%/92.8% in the non-cantilever group. Differences between both groups were not significant. The survival rate concerning loss of retention of CFDP retainers was 92.1% in the cantilever group. CONCLUSION: After 5 years of clinical service, CFDPs for the replacement of the second premolar showed no negative impact on the abutment tooth prognosis. CLINICAL SIGNIFICANCE: Cantilevered fixed dental prostheses present a viable treatment option in the shortened dental arch without compromising the medium-term abutment tooth prognosis.

The randomized shortened dental arch study: temporomandibular disorder pain.

OBJECTIVES: The aim of this multi-center, randomized controlled trial was to assess the impact of missing posterior support on the risk for temporomandibular disorder (TMD) pain by comparing patients with either shortened dental arches (SDA) or molar replacement by removable dental prostheses (RDP). METHODS: A sample of 215 patients with bilateral molar loss in at least one jaw was consecutively recruited in 14 prosthodontic departments of dental schools in Germany. Of the initial sample, 152 patients (mean age: 59.7 years; 53.9 % female) received randomly allocated interventions (SDA: n = 71; RDP: n = 81). Presence of TMD pain was assessed using patients' self-reports and was verified by physical examination and by pain intensity, as the mean of current pain, worst pain, and average pain in the last 6 months, with 10-point ordinal rating scales. Assessments were performed before treatment and at follow-ups until 60 months after treatment. Impact of interventions on TMD risk and pain intensity was computed by applying logistic and linear random-intercept models. RESULTS: Tooth replacement (RDP) did not significantly change the risk for self-reported (odds ratio [OR]: 1.1; confidence interval [CI]: 0.4 to 3.4) or clinically verified (OR: 0.7; CI: 0.1 to 4.3) TMD pain compared to no tooth replacement (SDA). Mean characteristic pain intensity was virtually identical in both groups (Coeff: 0.01; CI: -0.30 to 0.32). CONCLUSION: Retaining or preservation of an SDA is not a major risk factor for TMD pain over the course of 5 years when compared to molar replacement with RPDs. CLINICAL RELEVANCE: Seemingly, missing molars do not have to be replaced in order to prevent TMD pain.

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).