Enamel Caries
Conditions
Brief summary
To evaluate the efficacy of enamel remineralization by biomimetic hydroxyapatite contained in microRepair-based Biorepair Total Protection toothpaste compared to the use of Bio Enamel Caries and Erosion toothpaste based on Fluoro-Hydroxyapatite and BioActive Complex, evaluated with Diagnodent Pen and Diagnocam.
Detailed description
The recruited patients will be divided into: Group 1: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Biorepair Total Protection toothpaste 2 times/day Gruppo 2: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Curasept Biosmalto Caries and Erosion toothpaste 2 times/day For both groups, Diagnodent Pen will be used to evaluate the degree of demineralization, while Diagnocam will be used as qualitative evaluation. Other clinical indices to be collected are: plaque index (PI), bleeding index (BOP), basic erosive wear examination (BEWE), Schiff Air Index (SAI). The time frames of the study are: * T0: baseline * T1: after 1 month * T2: after 3 months * T3: after 6 months
Interventions
OTHERHome use
Home use twice a day
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* First permanent molars erupted and completely healthy * Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen
Exclusion criteria
* Patients with Diagnodent-stimulated value \> 25 * Patients with groove sealings of sealed permanent first molars or composite restorations * First molars with extensive demineralizations (Molar Incisor Hypomineralization, fluorosis, white/brown spots)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diagnodent Pen value | Study begin, 1, 3 and 6 months after the baseline | Scores (according to the manufacturer): 0 - 12: Normal prophylaxis (such as fluoride toothpaste) 13 - 24: Intensive prophylaxis (e.g. fluoridation, remineralisation) \> 25: Minimally invasive restorative procedures, composite filling materials and intensive prophylaxis (e.g. remineralisation, Air Abrasion, SONICflex micro), conventional restoration with large lesions, depending on risk assessment and findings. |
| Change in Diagnocam value | Study begin, 1, 3 and 6 months after the baseline | Qualitative evaluation. |
| Change in Schiff Air Index | Study begin, 1, 3 and 6 months after the baseline | 0: the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful. |
| Change in Bleeding on Probing | Study begin, 1, 3 and 6 months after the baseline | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%. |
| Change in Plaque Index | Study begin, 1, 3 and 6 months after the baseline | Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100 |
| Change in Basic Erosive Wear Examination | Study begin, 1, 3 and 6 months after the baseline | Scoring criteria (Barlet et al., 2008): 0: no erosive tooth wear; 1. initial loss of surface texture; 2. distinct defect, hard tissue loss \< 50% of the surface area; 3. hard tissue loss ≥ 50% of the surface area. |
Countries
Italy
Outcome results
None listed