Effect of Curodont™ Repair in Patients with Buccal Carious Lesions: A Mono-centre, Controlled, Split-mouth, Single-blinded, Randomised, Post-marketing Study

Phase 4

• Conditions: K02.9; Dental caries, unspecified

• Registration Number: DRKS00012941
• Lead Sponsor: credentis ag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-10-19
• Study Start: 2017-09-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Two buccal carious lesions which do not require operative intervention
• Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
• Patients must be able and willing to observe good oral hygiene throughout the study
• = 20 teeth and a plaque index of < 20%
• Age = 10 years and = 65 years
• Willing and able to attend the on-study visits
• Willing and able to understand all study-related procedures
• Written informed consent before participation in the study

Exclusion Criteria

• Secondary caries lesion on tooth
• Enamel aberration
• Carious lesions due to orthodontic treatment on tooth
• Evidence of tooth erosion (due to excessive acidic drink consumption or reflux)
• History of head and neck illnesses (e.g. head/neck cancer)
• Any pathology or concomitant medication affecting salivary flow or dry mouth
• Any metabolic disorders affecting bone turnover
• Concurrent participation in another clinical trial with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of the change in the lesion's size assessed by morphometry (on standardised photographs) from baseline D0 to D30 between investigational medical device and fluoride varnish.

Secondary Outcome Measures

Name	Time	Method
Difference of the change in the lesion's size assessed by morphometry (on standardised photographs) from baseline D0 to D90, D180, D360 between investigational medical device and fluoride varnish.