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

U

University of Pavia

Status

Completed

Conditions

Enamel Caries

Treatments

Other: Home use

Study type

Interventional

Funder types

Other

Identifiers

NCT06425536
2024-MOLARGROOVES

Details and patient eligibility

About

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.

Full 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

Enrollment

40 patients

Sex

All

Ages

6 to 18 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

Biorepair Total protection toothpaste
Experimental group
Treatment:
Other: Home use
Biosmalto Caries and Erosion
Active Comparator group
Treatment:
Other: Home use

Trial contacts and locations

1

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Central trial contact

Andrea Scribante, DDS, PhD

Data sourced from clinicaltrials.gov

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