Remineralization Effects of Hydroxyapatite Toothpaste

Therapuetic Areas:Dental / Maxillofacial Surgery
Age Range:18 - 50
Start Date:August 7, 2018
End Date:April 1, 2019
Contact:Bennett T. Amaechi, Prof.
Phone:1 210 567 3185

Use our guide to learn which trials are right for you!

Investigation of the Caries Prevention and Remineralization Effects of Hydroxyapatite Toothpaste

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.

The investigators hypothesize that (1) both the hydroxyapatite and the fluoridated toothpaste
promote caries remineralization that is significantly greater than zero, and (2) the two
toothpaste formulations are equally effective with respect to post-treatment remineralization
and inhibition of demineralization.

- Non-inferiority will be considered established if there is no statistically significant
difference in percentage of remineralization between the hydroxyapatite-containing
toothpaste and the fluoridated kid's toothpaste for any one measurement method.

- Superiority/inferiority will be considered established if at least 20% statistically
significant difference is observed between the hydroxyapatite-containing toothpaste and
the fluoridated kid's toothpaste for any one measurement method

Inclusion Criteria:

1. Male and/or female subjects 18 to 50 years inclusive

2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present

3. Willing to wear retainer 24 hours per day

4. No active, unrestored cavities

5. 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

6. Available throughout entire study

7. Willing to use only assigned products for oral hygiene throughout the duration of the

8. Must give written informed consent

9. Must be in good general health

10. 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

Exclusion Criteria:

1. Advanced periodontal disease

2. Medical condition which requires premedication prior to dental visits/procedures

3. Not enough teeth to secure the oral retainer

4. Diseases of the soft or hard oral tissues

5. Wearing of an orthodontic retainer(s)

6. Impaired salivary function

7. Current use of drugs that can affect salivary flow

8. Use of antibiotics one (1) month prior to or during this study

9. Positive urine test for pregnancy or self-reported breastfeeding. A urine pregnancy
test will be performed on female subjects of child-bearing potential.

10. Participation in another clinical study one (1) week prior to the start of the washout
period or during this study period

11. Use of tobacco products

12. Allergic history to common toothpaste ingredients

13. Allergic history to amino acids

14. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as
determined by review of medical history
We found this trial at
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
San Antonio, TX
Click here to add this to my saved trials