Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization

The purpose of this study is to evaluate

1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone
2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Study Overview

• Status: Completed
• Conditions: Tooth Decay
• Intervention / Treatment: Device: Fluoride Varnish; Device: Curodont Repair; Device: Curodont Protect

Detailed Description

Objectives: The purpose of this study is to evaluate

1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone
2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and pre-molars will be allocated in this randomized, controlled, single blinded study to one of the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont Repair+Curodont Protect) or control (Fluoride Varnish) group.

Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS) in addition to the Global Impression of Change Questionnaire will also be used for the evaluation of the outcome.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Early occlusal carious lesion which does not require an invasive treatment (ICDAS-II scores: 2 and 3)
• Size and form of the lesion: the lesion must both be fully visible and assessable and accessible
• Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
• Written informed consent before participation in the study

Exclusion Criteria:

• Evidence of tooth Erosion
• Fluoride varnish application < 3 months prior to study treatment
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180. => Group: Fluoride Varnish	Device: Fluoride Varnish; Fluor Protector S (Ivoclar, 7'700 ppm F-)
Experimental: Test1; Single application of Curodont Repair (P11-4) at Day 0 followed by a Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application. Another fluoride Varnish application at Day180. => Group: Curodont Repair + Fluoride Varnish	Device: Fluoride Varnish; Fluor Protector S (Ivoclar, 7'700 ppm F-); Device: Curodont Repair; P11-4 (monomeric peptide) - for professional use
Experimental: Test2; Single application of Curodont Repair (P11-4) at Day 0. Curodont Protect (tooth gel containing P11-4 matrix) is handed out and subjects are asked to apply it 2x weekly at home after regular teeth cleaning in the evening for the whole study period (Day 360). => Group: Curodont Repair + Curodont Protect	Device: Curodont Repair; P11-4 (monomeric peptide) - for professional use; Device: Curodont Protect; Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group	Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.	Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group	Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.	Day 90 and Day 360
Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group	Code 0: Sound tooth surface, no evidence of caries after prolonged air drying (5 sec). Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel. Code 3: Localized enamel breakdown due to caries with no visible dentine or underlying shadow. Code 4: Underlying dark shadow from dentine with or without enamel breakdown. Code 5: Distinct cavity with visible dentine. Code 6: Extensive distinct cavity with visible dentine (involving more than half of the dentine).	Day 90, Day 180, Day 360
Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group	Score 0: Sound. Score 1: Active caries - intact surface. Score 2: Active caries - surface discontinuity. Score 3: Active caries - cavity. Score 4: Inactive caries - intact surface. Score 5: Inactive caries - surface discontinuity. Score 6: Inactive caries - cavity.	Day 90, Day 180, Day 360
Mean of VAS values (Visual analogue scale) for each study group	Range: from -50 (strongly remineralizing) to +50 (stronlgy progressing)	Day 90, Day 180, Day 360
Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group	Investigator Questionnaire: evaluation ranging from "very much worse" to "very much better"; 7-point scale	Day 90, Day 180, Day 360

Collaborators and Investigators

• Sponsor: University Dentistry Clinical Center of Kosovo
• Investigators: Principal Investigator: Dafina Doberdoli, Dr., University Dentistry Clinical Center of Kosovo

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: 500

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No