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

NCT03780270 | Completed

• 1 other identifier: 500
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate

1. 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. 2.the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Conditions

Tooth Decay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group

  Day 90 and Day 360

• Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group

  Day 90, Day 180, Day 360

• Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group

  Day 90, Day 180, Day 360

• Mean of VAS values (Visual analogue scale) for each study group

  Day 90, Day 180, Day 360

• Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group

  Day 90, Day 180, Day 360

Study Arms (3)

Control

ACTIVE COMPARATOR

Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180. =\> Group: Fluoride Varnish

Device: Fluoride Varnish

Test1

EXPERIMENTAL

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; Device: Curodont Repair

Test2

EXPERIMENTAL

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; Device: Curodont Protect

Interventions

Fluoride Varnish DEVICE

Fluor Protector S (Ivoclar, 7'700 ppm F-)

Control; Test1

Curodont Repair DEVICE

P11-4 (monomeric peptide) - for professional use

Test1; Test2

Curodont Protect DEVICE

Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)

Test2

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Dentistry Clinical Center of Kosovo: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dafina Doberdoli, Dr.

  University Dentistry Clinical Center of Kosovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 19, 2018
• Study Start: June 16, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: December 19, 2018

Record last verified: 2018-12