Skip to main content
OpenTrials
Completed

NCT Number: NCT03780270

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tooth Decay Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Objectives: The purpose of this study is to evaluate

  • the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Fluoride varnish

Device

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

Curodont Repair

Device

P11-4 (monomeric peptide) - for professional use

Curodont Protect

Device

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

Primary outcomes

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

    Time frame: Day 180

    Diagnodent values for fissure caries:

    0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.

Secondary outcomes

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

    Time frame: Day 90 and Day 360

    Diagnodent values for fissure caries:

    0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.

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

    Time frame: Day 90, Day 180, Day 360

    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).

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

    Time frame: Day 90, Day 180, Day 360

    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.

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

    Time frame: Day 90, Day 180, Day 360

    Range: from -50 (strongly remineralizing) to +50 (stronlgy progressing)

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

    Time frame: Day 90, Day 180, Day 360

    Investigator Questionnaire: evaluation ranging from "very much worse" to "very much better"; 7-point scale

Sponsors and collaborators

Lead sponsor

University Dentistry Clinical Center of Kosovo

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2018
Registry last updated
Dec 19, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.