Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam

Efficacy of Remineralizing Products Used in Molar Grooves: RCT With Evaluation With Diagnodent Pen and Diagnocam

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.

Study Overview

• Status: Completed
• Conditions: Enamel Caries
• Intervention / Treatment: Other: Home use

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biorepair Total protection toothpaste	Other: Home use; Home use twice a day
Active Comparator: Biosmalto Caries and Erosion	Other: Home use; Home use twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diagnodent Pen value	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.	Study begin, 1, 3 and 6 months after the baseline
Change in Diagnocam value	Qualitative evaluation.	Study begin, 1, 3 and 6 months after the baseline
Change in Schiff Air Index	0: the subject did not respond to air blasting; the subject responded to air blasting;; the subject responded to air blasting and requested discontinuation;; the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.	Study begin, 1, 3 and 6 months after the baseline
Change in Bleeding on Probing	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%.	Study begin, 1, 3 and 6 months after the baseline
Change in Plaque Index	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	Study begin, 1, 3 and 6 months after the baseline
Change in Basic Erosive Wear Examination	Scoring criteria (Barlet et al., 2008): 0: no erosive tooth wear; initial loss of surface texture;; distinct defect, hard tissue loss < 50% of the surface area;; hard tissue loss ≥ 50% of the surface area.	Study begin, 1, 3 and 6 months after the baseline

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-MOLARGROOVES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No