## Protocol Section
### Identification Module
**NCT ID:** NCT06425536

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

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

#### Organization Study ID Info
**ID:** 2024-MOLARGROOVES
#### Organization
**Class:** OTHER
**Full Name:** University of Pavia
### Status Module
#### Completion Date
**Date:** 2025-01-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pavia

#### Responsible Party

**Investigator Affiliation:** University of Pavia

**Investigator Full Name:** Andrea Scribante

**Investigator Title:** Associate Professor, Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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

### Conditions Module

**Conditions:**

- Enamel Caries

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Home use

**Label:** Biorepair Total protection toothpaste

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Home use

**Label:** Biosmalto Caries and Erosion

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Biorepair Total protection toothpaste

- Biosmalto Caries and Erosion

**Description:** Home use twice a day

**Name:** Home use

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in Diagnodent Pen value

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

**Description:** Qualitative evaluation.

**Measure:** Change in Diagnocam value

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

**Description:** 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.

**Measure:** Change in Schiff Air Index

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

**Description:** 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%.

**Measure:** Change in Bleeding on Probing

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

**Description:** 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

**Measure:** Change in Plaque Index

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

**Description:** 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.

**Measure:** Change in Basic Erosive Wear Examination

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

### Eligibility Module

**Eligibility Criteria:** 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)

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** andrea.scribante@unipv.it

**Name:** Andrea Scribante, DDS, PhD

**Phone:** +39 0382516223

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Pavia

**Country:** Italy

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

**State:** Lombardy

**Zip:** 27100

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pavia

**Name:** Andrea Scribante, DDS, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Data will be available upon motivated request to the Principal Investigator.

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
