Tooth DecayNCT03780270
Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
A study testing Fluoride Varnish, Curodont Repair and Curodont Protect in people with Tooth Decay, run by University Dentistry Clinical Center of Kosovo.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Tooth Decay
- What is being tested?
- Fluoride Varnish, Curodont Repair and Curodont Protect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2014to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
Read the detailed description
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.
- Conditions
- Tooth Decay
- Being tested
- Fluoride Varnish, Curodont Repair, Curodont Protect
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride VarnishDevice
Fluor Protector S (Ivoclar, 7'700 ppm F-)
Curodont RepairDevice
P11-4 (monomeric peptide) - for professional use
Curodont ProtectDevice
Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180.
=> Group: Fluoride Varnish Receives: 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 Receives: 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 Receives: Device: Curodont Repair; Device: Curodont Protect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 180
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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
Measured: Day 90, Day 180, Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start16 Jun 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Dentistry Clinical Center of Kosovo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dafina Doberdoli, University Clinical Centre of Kosova
- Investigators
- Dafina Doberdoli, Dr., Principal investigator, University Dentistry Clinical Center of Kosovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780270
- Sponsor's protocol ID
- 500
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
- ClinicalTrials.gov ID
- NCT03780270
- Acronym / sponsor ID
- 500
- Conditions
- Tooth Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Dentistry Clinical Center of KosovoUniversity, hospital or other
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Fluoride VarnishFluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180. => Group: Fluoride Varnish |
| Test1 | Experimental | Device: Fluoride Varnish, Device: Curodont RepairSingle 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 |
| Test2 | Experimental | Device: Curodont Repair, Device: Curodont ProtectSingle 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 |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride VarnishFluor Protector S (Ivoclar, 7'700 ppm F-) | Device | Control, Test1 |
| Curodont RepairP11-4 (monomeric peptide) - for professional use | Device | Test1, Test2 |
| Curodont ProtectTooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC) | Device | Test2 |
Primary outcome
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.
5 secondary outcomes
Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group
Time frame: Day 90 and Day 360
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
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
Mean of VAS values (Visual analogue scale) for each study group
Time frame: Day 90, Day 180, Day 360
Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group
Time frame: Day 90, Day 180, Day 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dafina Doberdoli, Dr. principal investigator
University Dentistry Clinical Center of Kosovo
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride Varnish, Curodont Repair and Curodont Protect in people with Tooth Decay, run by University Dentistry Clinical Center of Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group (time frame: Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.