Study on High-Dosage Fluoride Toothpaste for Patients with Dental Root Caries

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What is this study about?

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.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as being 18 years or older and having a lower partial denture.

2 initial instructions

Receive detailed instructions on how to use the high-dosage fluoride toothpaste provided for the study.

Understand the purpose of the study, which is to assess the effectiveness of a 5,000 ppm fluoride toothpaste compared to a 1,450 ppm fluoride toothpaste in controlling dental root caries.

3 toothpaste usage

Use the provided fluoride toothpaste as directed. The toothpaste is to be used orally.

The frequency and duration of toothpaste use will be specified by the study coordinators.

4 monitoring and assessments

Participate in regular assessments to monitor the mineral loss or uptake in dental root slabs.

The study will also measure the fluoride concentration in saliva and biofilm.

5 completion of study

The study is expected to conclude by August 1, 2024.

Upon completion, results will be analyzed to determine the effectiveness of the high-dosage fluoride toothpaste in controlling root caries.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Aarhus University Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
15.09.2022

Trial locations

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.

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.

Trial ID:
2022-500059-22-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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