An interventional study of Fluoride Varnish and Curodont Repair in Tooth Decay, sponsored by University Dentistry Clinical Center of Kosovo. Completed. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by University Dentistry Clinical Center of Kosovo · Not applicable, Interventional, and Treatment
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: 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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →This is the only study on the registry with University Dentistry Clinical Center of Kosovo as lead sponsor.
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Exclusion Criteria:
Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180. =\> Group: Fluoride Varnish
Device: Fluoride Varnish
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 · Device: Curodont Repair
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 · Device: Curodont Protect
Fluor Protector S (Ivoclar, 7'700 ppm F-)
P11-4 (monomeric peptide) - for professional use
Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)
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.
Time frame: Day 180
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.
Time frame: 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).
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
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.
Time frame: 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)
Time frame: 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
Time frame: Day 90, Day 180, Day 360
No study locations are listed for this record.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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