|- candidate number||21736|
|- NTR Number||NTR5012|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mrt-2015|
|- Secondary IDs||BCM Oosterkamp|
|- Public Title||Effectiveness of a clinical guideline to improve the dental health in orthodontic patients with fixed appliances: study protocol for a cluster randomized trial|
|- Scientific Title||Effectiveness of a clinical guideline to improve the dental health in orthodontic patients with fixed appliances: study protocol for a cluster randomized trial|
|- ACRONYM||Guideline effectivness orthodontics|
|- hypothesis||The aim of this study is twofold:
1)To assess the effectiveness of a CPG converted into a CDSS, in actually preventing the development of WSLs during orthodontic treatment with fixed appliances compared to usual preventive measures.
2)To evaluate the effect of a multifaceted implementation strategy of a CPG based CDSS into routine clinical practice.
|- Healt Condition(s) or Problem(s) studied||Enamel carious lesions, Orthodontic treamtent, Guidelines, Prevention, Efficacy|
|- Inclusion criteria||All patients between 12 and 18 years of age, with fully erupted permanent dentition, who are scheduled for treatment with full fixed appliances, are eligible to participate in this study. |
|- Exclusion criteria||-Patients younger than 12 years of age because they do not have a fully erupted dentition, patients older than 18 years of age because after this age the risk of development of WSLs is reduced. |
-Patient diagnosed with astma bronchiale because the use of Durphat is contra-indicated.
-Patients with physical or mental problems incapable of practicing proper oral hygiene.
-Patients who refuse to use prescribed preventive products or are allergic to these products.
-Patients with missing incisors, canines and/or premolars because these are the teeth being scored.
-Patients with cleft lip and palate and craniofacial anomalies because for these patients different preventive strategies are needed.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate |
|- planned closingdate|
|- Target number of participants||840|
|- Interventions||the implementation of a CPG for prevention of WSLs prior and during orthodontic treatment with fixed appliances|
|- Primary outcome||Primary outcome|
The primary outcome measure is the incidence of WSLs after 6 to 9 months of treatment with fixed appliances and at the end of treatment using the CPG for prevention of WSLs compared to usual preventive measures in patients treated with full fixed orthodontic appliances.
|- Secondary outcome||Secondary outcomes|
Secondary outcome is adoption of the CPG in routine clinical orthodontic practice. This will be measured in terms of :
- Professionals attitude toward working with the CPG for prevention of WSLs, measured by means of a questionnaire.
-Professionals compliance with key recommendations in the CPG for prevention of WSLs, measured by auditing the EPF.
-Patients views on the preventive care provided, measured by means of an questionnaire .
|- Timepoints||T0(before treatment), T1 (6-9 months into treatment with fixed appliances) and T2 (end of treatment with fixed appliances) |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| B.C.M. Oosterkamp|
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Nederlandse Vereniging van Orthodontisten|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||2-mrt-2015 - 7-apr-2015|