Completed

NCT Number: NCT02537327

Incidence of Recurrent Caries Next to Tooth Restorations

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.

Completed

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Key information

Conditions

Recurrent Caries

Sex eligibility

All sexes

Study type

Observational

Primary location

KU Leuven and UZ Leuven, Department of oral health sciences

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Sep 1, 2015
Registry last updated: Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.