Incidence of Recurrent Caries Next to Tooth Restorations

Completed

• Conditions: Recurrent Caries

• Registration Number: NCT02537327
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-09-01
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of recurrent caries	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

Name	Time	Method
Caries risk of the patient	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.

Trial Locations

Locations (1)

KU Leuven and UZ Leuven, Department of oral health sciences; 🇧🇪 Leuven, Belgium