Overview
Sponsor-declared trial summary
Phenomena and Processes (Fluoride in dental caries control)
To assess to which extent using a high-dosage fluoride toothpaste (5,000 ppm) rather than a normal fluoride toothpaste (1,450 ppm) (establishing a higher concentration of fluoride in the oral environment) will result in more arrest of root caries lesions and hinder more root caries lesion formation (in experimental in …
Key facts
- Sponsor
- Aarhus University
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Trial duration
- 24 Mar 2023 → 22 Apr 2024
- Decision date (initial)
- 2022-10-31
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Patentmedelsfonden (private Swedish fund) · Tandlægeforeningens Forskningsudvalg (FORSKU) og Forskningsfond (the Danish Dental Association)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess to which extent using a high-dosage fluoride toothpaste (5,000 ppm) rather than a normal fluoride toothpaste (1,450 ppm) (establishing a higher concentration of fluoride in the oral environment) will result in more arrest of root caries lesions and hinder more root caries lesion formation (in experimental in situ specimens), even though no mechanical biofilm-removal takes place.
Conditions and MedDRA coding
Phenomena and Processes (Fluoride in dental caries control)
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500059-22-00 | High-dosage fluoride toothpaste for root caries control (in situ): a randomized, controlled clinical trial | Aarhus University |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Age ≥ 18 years old
- Lower partial denture
Exclusion criteria 4
- Hyposalivation (< 0,5 ml / 5 mins)
- Hypersensitivity to any of the components in the trial toothpastes
- Pregnancy
- Breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mineral loss / uptake in experimental bovine dental root slabs (in situ)
Secondary endpoints 1
- The fluoride concentration in saliva and biofilm (on the bovine dental root slabs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD489292 · Product
- Active substance
- Fluoride
- Pharmaceutical form
- TOOTHPASTE
- Route of administration
- ORAL USE
- Max daily dose
- 3 g gram(s)
- Max total dose
- 99 g gram(s)
- Max treatment duration
- 99 Month(s)
- Authorisation status
- Authorised
- ATC code
- A01AA01 — SODIUM FLUORIDE
- Marketing authorisation
- 34657
- MA holder
- COLGATE PALMOLIVE A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Toothpaste (cosmetic product), fluoride concentration: 1,450 ppm
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University
- Sponsor organisation
- Aarhus University
- Address
- Vennelyst Boulevard 6
- City
- Aarhus C
- Postcode
- 8000
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University
- Contact name
- Primary investigator
Public contact point
- Organisation
- Aarhus University
- Contact name
- Primary investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-03-24 | 2024-04-22 | 2023-05-11 | 2023-11-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Preliminary summary results SUM-75552
|
2025-03-19T14:32:04 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Preliminary layman summary | 2025-03-19T14:34:41 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layman_summary__2022_500059_22_01_dated19032025 | 1 |
| Summary of results (for publication) | Results_summary_2022_500059_22_01_dated19032025 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-03 | Denmark | Acceptable 2022-10-31
|
2022-10-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2023-11-17 | Denmark | Acceptable 2022-10-31
|
2023-11-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-15 | Denmark | Acceptable 2024-01-05
|
2024-01-07 |