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

NCT06425536 | Completed

• 1 other identifier: 2024-MOLARGROOVES
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Enamel Caries

Outcome Measures

Primary Outcomes (6)

• 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; 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.

  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; 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.

  Study begin, 1, 3 and 6 months after the baseline

Study Arms (2)

Biorepair Total protection toothpaste

EXPERIMENTAL

Other: Home use

Biosmalto Caries and Erosion

ACTIVE COMPARATOR

Other: Home use

Interventions

Home use OTHER

Home use twice a day

Biorepair Total protection toothpaste; Biosmalto Caries and Erosion

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• First permanent molars erupted and completely healthy
• Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: May 1, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 30, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)