Incidence of Recurrent Caries Next to Tooth Restorations

Recurrent Caries Clinical Trial

Official title:

Epidemiological Study on the Incidence and Characteristics of Secondary Caries Next to Tooth Restorations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537327
• Other study ID #: S56046
• Status: Completed
• Phase: N/A
• First received: August 19, 2015
• Last updated: November 22, 2016
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Recurrent Caries

Locations

Country	Name	City	State
Belgium	KU Leuven and UZ Leuven, Department of oral health sciences	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of recurrent caries	Number of recurrent caries lesions (new caries lesion next to restoration) within a specified time period divided by the total number of restorations.	Two years	No
Secondary	Caries risk of the patient	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.	Two years	No