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

Enamel Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425536
• Other study ID #: 2024-MOLARGROOVES
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 20, 2025

Study information

• Verified date: May 2024
• Source: University of Pavia
• Contact: Andrea Scribante, DDS, PhD
• Phone: +39 0382516223
• Email: andrea.scribante[@]unipv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 20, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Enamel Caries

Intervention

Other:
• Home use
Home use twice a day

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Diagnocam value	Qualitative evaluation.	Study begin, 1, 3 and 6 months after the baseline
Primary	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
Primary	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
Primary	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
Primary	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