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Trial record 56 of 1200 for:    tooth decay

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03780270
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dafina Doberdoli, University Clinical Centre of Kosova

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Tooth Decay Device: Fluoride Varnish Device: Curodont Repair Device: Curodont Protect Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
Actual Study Start Date : June 16, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
Drug Information available for: Fluoride

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780270


Sponsors and Collaborators
University Dentistry Clinical Center of Kosovo
Investigators
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Principal Investigator: Dafina Doberdoli, Dr. University Dentistry Clinical Center of Kosovo

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Responsible Party: Dafina Doberdoli, Principal Investigator, University Clinical Centre of Kosova
ClinicalTrials.gov Identifier: NCT03780270     History of Changes
Other Study ID Numbers: 500
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs