Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
NCT ID: NCT03780270
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2014-06-16
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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: Curodontâ„¢ 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180.
=\> Group: Fluoride Varnish
Fluoride Varnish
Fluor Protector S (Ivoclar, 7'700 ppm F-)
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
Fluoride Varnish
Fluor Protector S (Ivoclar, 7'700 ppm F-)
Curodont Repair
P11-4 (monomeric peptide) - for professional use
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
Curodont Repair
P11-4 (monomeric peptide) - for professional use
Curodont Protect
Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluoride Varnish
Fluor Protector S (Ivoclar, 7'700 ppm F-)
Curodont Repair
P11-4 (monomeric peptide) - for professional use
Curodont Protect
Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
6 Years
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Dentistry Clinical Center of Kosovo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dafina Doberdoli
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dafina Doberdoli, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Dentistry Clinical Center of Kosovo
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
500
Identifier Type: -
Identifier Source: org_study_id