| Literature DB >> 26639787 |
R Wendell Evans1, Paula Clark1, Nan Jia2.
Abstract
OBJECTIVES: To report, at two and 4 years post-trial, on the potential legacy of a 3-year randomized controlled clinical trial (RCT) of the Caries Management System (CMS) at private general dental practices. The CMS was designed to reduce caries risk and need for restorative care.Entities:
Keywords: cariology; dental services research; non-surgical treatment; preventive dentistry; risk assessment
Mesh:
Year: 2015 PMID: 26639787 PMCID: PMC5324629 DOI: 10.1111/cdoe.12204
Source DB: PubMed Journal: Community Dent Oral Epidemiol ISSN: 0301-5661 Impact factor: 3.383
Figure 1Study flow diagram.
Figure 2Year 3 distribution of patient mean DMFT increments by intervention and practice participation postclinical trial.
Frequency distribution of practices by location and fluoridation status
| Follow‐up period | Intervention | City | Urban | Rural | Total | Fluoridated | |
|---|---|---|---|---|---|---|---|
| Yes | No | ||||||
| Baseline to year 3 | CMS | 2 | 3 | 5 | 10 | 8 | 2 |
| Control | 2 | 3 | 4 | 9 | 7 | 2 | |
| Years 4 and 5 | CMS | 1 | 2 | 1 | 4 | 4 | 0 |
| Control | 2 | 3 | 3 | 8 | 7 | 1 | |
| Years 4–7 | CMS | 1 | 2 | 1 | 4 | 4 | 0 |
| Control | 1 | 3 | 3 | 7 | 6 | 1 | |
Twenty‐two practices were randomized at baseline but three withdrew prior to patient recruitment.
Caries Management System.
Caries Management System arm and Control arm mean baseline DMFT balance by cohort
| Cohort | Practice numbers | Total patients | Caries Management System | Control | Probability | ||||
|---|---|---|---|---|---|---|---|---|---|
|
| Mean | SD |
| Mean | SD | ||||
| All patients on enrollment | 19 | 902 | 452 | 8.5 | 8.2 | 450 | 8.4 | 8.6 | 0.82 |
| All patients who continued to year 3 | 19 | 811 | 411 | 9.2 | 7.7 | 400 | 12.0 | 8.4 | <0.0001 |
| All patients who continued to year 5 | 12 | 302 | 63 | 12.1 | 7.4 | 239 | 11.7 | 8.1 | 0.74 |
| All patients who continued to year 7 | 11 | 214 | 52 | 12.2 | 7.5 | 162 | 12.6 | 7.9 | 0.74 |
Wilcoxon test comparing CMS against Control.
Post‐trial patient‐level and practice‐level DMFTa increments and related statistics by treatment period and intervention – Caries Management System (CMS) versus Control – LOCFb
| Treatment period | Intervention | Practice numbers | Patient‐level statistics | Probability | % Difference | |||||
|---|---|---|---|---|---|---|---|---|---|---|
|
| Median | Mode | Max | Adjusted mean | SE | |||||
| First post‐trial period (Years 4–5) | CMS | 4 | 63 | 0 | 0 | 10 | 1.21 | 0.29 | 0.3234 | 20.9 |
| Control | 8 | 239 | 1 | 0 | 10 | 1.53 | 0.18 | |||
| Second post‐trial period (Years 6–7) | CMS | 4 | 52 | 1 | 0 | 5 | 1.23 | 0.24 |
| 31.7 |
| Control | 7 | 162 | 1 | 0 | 24 | 1.80 | 0.15 | |||
| Post‐trial period (Years 4–7) | CMS | 4 | 52 | 1 | 0 | 10 | 2.44 | 0.31 |
| 28.0 |
| Control | 7 | 162 | 2 | 0 | 27 | 3.39 | 0.20 | |||
| Baseline – year 3 | CMS | 6 | 63 | 1 | 0 | 11 | 3.99 | 0.55 |
| 37.7 |
| Control | 8 | 239 | 2 | 0 | 22 | 5.44 | 0.39 | |||
| Baseline – year 5 | CMS | 4 | 63 | 2 | 0 | 19 | 4.95 | 0.55 |
| 25.8 |
| Control | 8 | 239 | 3 | 0 | 27 | 6.67 | 0.39 | |||
| Baseline – year 7 | CMS | 4 | 52 | 3.5 | 0 | 19 | 6.13 | 0.58 |
| 29.2 |
| Control | 7 | 162 | 5 | 3 | 32 | 8.66 | 0.41 | |||
Bold indicates significance (P < 0.05).
Calculated as M+F where F = sum of all (i) first time fillings, (ii) crowns, (iii) repeat fillings including repeat crowns, (iv) root fillings, (v) bridge units, (vi) denture units, and (vii) implants.
Last observation carried forward.
Mean values are adjusted for baseline DMFT and baseline age. SE of adjusted mean.
Relate to CMS versus Control differences.
Logistic regression analysis of high caries risk status.a Odds ratios adjusted for risk factors
| Risk factor | OR | CI95 |
|---|---|---|
| Age on enrollment | 1.022 | 0.998, 1.046 |
| Baseline DMFT | 1.168 |
|
| Fluoride history | 0.154 | 0.018, 1.307 |
| Intervention (CMS) | 0.228 |
|
Bold indicates significance (P < 0.05).
Dichotomized as high risk versus low or medium risk.
Current exposure to water fluoridation. Comparator reference = Noncurrent exposure.
Comparator reference = Control (usual care).