Remineralization Effects of Hydroxyapatite Toothpaste

Caries, Dental Clinical Trial

Official title:

Investigation of the Caries Prevention and Remineralization Effects of Hydroxyapatite Toothpaste

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681340
• Other study ID #: REHT18
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2019
• Source: Dr. Kurt Wolff GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 study

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

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

Intervention

Other:
• Hydroxyapatite toothpaste
If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
• Fluoridated toothpaste
If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Joachim Enax

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries remineralization	Analyis of mineral gain/loss and lesion depth by microradiography	4 weeks