Enamel CariesNCT06425536
Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam
A study testing Home use in people with Enamel Caries, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Caries
- What is being tested?
- Home use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- First permanent molars erupted and completely healthy
- Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Efficacy of Remineralizing Products Used in Molar Grooves: RCT With 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.
Read the 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
- Enamel Caries
- Being tested
- Home use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home useOther
Home use twice a day
| Study group | Role | What they receive |
|---|---|---|
| Biorepair Total protection toothpaste | Experimental | Not described Receives: Other: Home use |
| Biosmalto Caries and Erosion | Active comparator | Not described Receives: Other: Home use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study begin, 1, 3 and 6 months after the baseline
Change in Diagnocam value
Qualitative evaluation.
Measured: Study begin, 1, 3 and 6 months after the baseline
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.
Measured: 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%.
Measured: 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
Measured: 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;
- initial loss of surface texture;
- distinct defect, hard tissue loss < 50% of the surface area;
- hard tissue loss ≥ 50% of the surface area.
Measured: Study begin, 1, 3 and 6 months after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 May 2024
- Primary completion25 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425536
- Sponsor's protocol ID
- 2024-MOLARGROOVES
- Status last verified
- Dec 2024
- First submitted
- 17 May 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Remineralizing Products Used in Molar Grooves: RCT With Evaluation With Diagnodent Pen and Diagnocam
- ClinicalTrials.gov ID
- NCT06425536
- Acronym / sponsor ID
- 2024-MOLARGROOVES
- Conditions
- Enamel Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biorepair Total protection toothpaste | Experimental | Other: Home use |
| Biosmalto Caries and Erosion | Active comparator | Other: Home use |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- First permanent molars erupted and completely healthy
- Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home useHome use twice a day | Other | Biorepair Total protection toothpaste, Biosmalto Caries and Erosion |
Primary outcome
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.
Change in Diagnocam value
Time frame: Study begin, 1, 3 and 6 months after the baseline
Qualitative evaluation.
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; 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.
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%.
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
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; 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
Related trials for Enamel Caries
Recruiting
Nano-Silver Versus Bioactive Glass for Primary Teeth Exposed to Therapeutic Radiation
Radiation Caries
Not yet recruitingPhase 4
Enamel Lesion Detection With New DX Tool
Enamel Lesions, Caries
Active, not recruiting
Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth
Molar-Incisor Hypomineralization (MIH)
Recruiting
Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries
Initial Dental Caries
Active, not recruiting
Zirconia and Bioflx Crowns for Primary Anterior Teeth
Dental Caries, Tooth Hypomineralization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home use in people with Enamel Caries, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diagnodent Pen value (time frame: Study begin, 1, 3 and 6 months after the baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.