Remineralization Effects of Hydroxyapatite Toothpaste

Completed · Not applicable

Conditions studied: Caries, Dental

In brief

The objective of this in situ clinical study is to determine whether a toothpaste containing hydroxyapatite microclusters is as effective as a fluoridated kid's toothpaste in promoting remineralization of early caries lesions and inhibiting the development of caries lesions.

Key facts

Study ID

NCT03681340

Run by

Dr. Joachim Enax

People needed

32

Starts

2018-08-07

Expected to finish

2019-06-01

Last updated by the study team

2019-07-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and/or female subjects 18 to 50 years inclusive
• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
• Willing to wear retainer 24 hours per day
• No active, unrestored cavities
• Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively) ascertained from a preliminary sialometry test
• Available throughout entire study
• Willing to use only assigned products for oral hygiene throughout the duration of the study
• Must give written informed consent
• Must be in good general health
• No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

You may not qualify if…

• Advanced periodontal disease
• Medical condition which requires premedication prior to dental visits/procedures
• Not enough teeth to secure the oral retainer
• Diseases of the soft or hard oral tissues
• Wearing of an orthodontic retainer(s)
• Impaired salivary function
• Current use of drugs that can affect salivary flow
• Use of antibiotics one (1) month prior to or during this study
• Positive urine test for pregnancy or self-reported breastfeeding. A urine pregnancy test will be performed on female subjects of child-bearing potential.
• Participation in another clinical study one (1) week prior to the start of the washout period or during this study period
• Use of tobacco products
• Allergic history to common toothpaste ingredients
• Allergic history to amino acids
• Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history

Where it is running

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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