Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate
Objectives: The purpose of this study is to evaluate
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180. => Group: 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride Varnish | Device | Fluor Protector S (Ivoclar, 7'700 ppm F-) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 90 and Day 360 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dafina Doberdoli, Dr. | University Dentistry Clinical Center of Kosovo | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
|
| 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). |
| 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. | 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) | 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 | Day 90, Day 180, Day 360 |