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Effectiveness of a clinical guideline to improve the dental health in orthodontic patients with fixed appliances: study protocol for a cluster randomized trial

Effectiveness of a clinical guideline to improve the dental health in orthodontic patients with fixed appliances: study protocol for a cluster randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24400
Enrollment
840
Registered
2015-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enamel carious lesions, white spot, prevention, guideline, effectivness, orthodontic treamtent. Ontkalkingen, richtlijn, effectiviteit, preventie, orthodontische behandeling.

Interventions

the implementation of a CPG for prevention of WSLs prior and during orthodontic treatment with fixed appliances

Sponsors

Radboud University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 .

Contacts

Public ContactB.C.M. Oosterkamp

Radboud University Medical Center,

barbara.oosterkamp@radboudumc.nl+31 24 3614005

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)