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Incidence of Recurrent Caries Next to Tooth Restorations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02537327
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : November 23, 2016
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
The aim of this study is to determine the incidence of recurrent caries around the different types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better characterize recurrent caries lesions in terms of location and size of the lesions and type, material and age of the restoration.

Condition or disease
Recurrent Caries

Detailed Description:
The data will be collected from patients who are visiting the dental clinic for a check-up. These data will be retrieved in the patient records. In particular the clinical (mouth) exam and the radiographic images ('RX-bite-wings'), which are routinely taken during these check-up consultations, will be used for the evaluation of recurrent caries. Information regarding medical background, oral hygiene, sugar eating habits and possible parafunctional activities will also be gathered from the patient files. In addition, caries risk of the patients will be assessed using commercial kits for analysis of their saliva (Saliva-Check Buffer, GC, Tokyo, Japan) and dental plaque (Tri Plaque ID Gel, GC, Tokyo, Japan), which are a part of the routine care of the patients at the clinic.

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Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Epidemiological Study on the Incidence and Characteristics of Secondary Caries Next to Tooth Restorations
Study Start Date : August 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Primary Outcome Measures :
  1. Incidence of recurrent caries [ Time Frame: Two years ]
    Number of recurrent caries lesions (new caries lesion next to restoration) within a specified time period divided by the total number of restorations.

Secondary Outcome Measures :
  1. Caries risk of the patient [ Time Frame: Two years ]
    Caries risk of each patient will be assessed based on scoring of several parameters such as: number of new caries lesions in the last 3 years (from patients' files), presence of relevant systemic disease (from patients' files), sugar consumption (from patients' files), oral hygiene (from patients' files) and results of the Saliva-check test and Tri plaque ID test.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up

Inclusion Criteria:

  • Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up

Exclusion Criteria:

  • Patients for who not all necessary data could be registered (incomplete mouth exam records, missing RX-bite wings, etc)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02537327

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KU Leuven and UZ Leuven, Department of oral health sciences
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Study Chair: Kirsten L. Van Landuyt, DDS, PhD BIOMAT, Department of Oral Health Sciences, University of Leuven & Dentistry University Hospitals Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT02537327    
Other Study ID Numbers: S56046
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: June 2016
Keywords provided by Universitaire Ziekenhuizen Leuven:
Recurrent caries
Secondary caries
Dental composite
Dental amalgam