Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam
- Conditions
- Enamel Caries
- Interventions
- Other: Home use
- Registration Number
- NCT06425536
- Lead Sponsor
- University of Pavia
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- First permanent molars erupted and completely healthy
- Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biosmalto Caries and Erosion Home use - Biorepair Total protection toothpaste Home use -
- Primary Outcome Measures
Name Time Method 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 x100Change 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy