Aarhus University
Verified
Aarhus, Denmark
Not recruitingTooth disorder
Study on High-Dosage Fluoride Toothpaste for Patients with Dental Root Caries
Verified siteRegistered drug
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of using a high-dosage fluoride toothpaste to control dental root caries, which are cavities that form on the roots of teeth. The study compares a high-dosage fluoride toothpaste, specifically Duraphat with a fluoride concentration of 5,000 parts per million (ppm), to a normal fluoride toothpaste with a concentration of 1,450 ppm. The aim is to see if the higher concentration of fluoride can better stop the development of root caries and prevent new ones from forming, even without the usual cleaning of the teeth to remove plaque.
The trial involves using these toothpastes on experimental samples to observe the effects on dental root health. The main focus is on how much mineral is lost or gained in the dental roots when using these toothpastes. Additionally, the study will measure the amount of fluoride present in saliva and the plaque that forms on the dental roots. This research is important for understanding how different fluoride concentrations can impact dental health, particularly in preventing and controlling root caries.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
2 criteria
- Must be 18 years old or older.
- Must have a lower partial denture (a removable dental appliance that replaces some missing teeth in the lower jaw).
Who cannot join the trial?
5 criteria
- Patients who are not within the specified age range for the study.
- Patients who are part of a vulnerable population, which means groups of people who might need special protection or care.
- Patients who have any medical conditions that might interfere with the study or its results.
- Patients who are unable to use the study's toothpaste as required.
- Patients who are not willing or able to follow the study procedures.
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Investigated drugs
Fluoride Toothpaste is a special type of toothpaste that contains fluoride, a mineral that helps protect teeth from decay. In this clinical trial, the toothpaste is used to see if it can help stop or slow down the formation of cavities on the roots of teeth. The trial compares a high-dosage fluoride toothpaste with a normal fluoride toothpaste to find out which one is more effective in preventing root cavities. The high-dosage toothpaste has more fluoride, which might make it better at protecting teeth, even without brushing to remove plaque.
What is already known about the treatment
High-dosage fluoride toothpaste – This medication is administered in the form of toothpaste and is applied directly to the teeth during regular brushing. It is currently being studied in clinical trials to determine its effectiveness in controlling root caries, a type of tooth decay. The main therapeutic indication is to prevent and arrest the formation of root caries lesions. At the molecular level, fluoride works by enhancing the remineralization of tooth enamel and inhibiting the demineralization process, thereby strengthening the teeth and making them more resistant to decay. This medication falls under the pharmacological classification of dental caries prophylactic agents.
Investigated diseases
Dental Caries – Dental caries, commonly known as tooth decay, is a process where the hard surface of the teeth is damaged due to acids made by bacteria. It begins with the demineralization of the tooth enamel, leading to the formation of cavities. If untreated, the decay can progress deeper into the tooth, affecting the dentin and potentially reaching the pulp. This progression can cause pain and sensitivity, especially when consuming hot, cold, or sweet foods. Over time, the structural integrity of the tooth can be compromised, leading to further complications. The presence of fluoride can help in remineralizing the enamel and slowing down the progression of caries.
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Study on Alveolar Bone Augmentation Using Mesenchymal Stem Cells and Biphasic Calcium Phosphate for Patients with Jaw Bone Defects
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- Disease:Alveolar bone defect
- Substances:Mesenchymal Stromal Cells, Ex Vivo Cultured
Countries:
Norway
Norway- Participants:18–64 years · 65+ years
- Substances:Mesenchymal Stromal Cells, Ex Vivo Cultured
- Sponsor:University of Bergen
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500059-22-01Estimated enrolment10 patientsSponsorAarhus University
sourced from the EU Clinical Trials Register and site verification
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