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Completed

NCT Number: NCT06425536

Efficacy of Remineralizing Products Used in Molar Grooves: 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.

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Key information

Conditions

Enamel Caries

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Home use

Other

Home use twice a day

Primary outcomes

  1. Change in Diagnodent Pen value

    Time frame: 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.

  2. Change in Diagnocam value

    Time frame: Study begin, 1, 3 and 6 months after the baseline

    Qualitative evaluation.

  3. Change in Schiff Air Index

    Time frame: Study begin, 1, 3 and 6 months after the baseline

    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.

  4. Change in Bleeding on Probing

    Time frame: 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%.

  5. Change in Plaque Index

    Time frame: 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

  6. Change in Basic Erosive Wear Examination

    Time frame: Study begin, 1, 3 and 6 months after the baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 22, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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