Remineralization Effects of Hydroxyapatite Toothpaste

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.

Study Overview

• Status: Completed
• Conditions: Caries, Dental
• Intervention / Treatment: Other: Hydroxyapatite toothpaste; Other: Fluoridated toothpaste

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxyapatite toothpaste; 4 weeks toothbrushing with a hydroxyapatite toothpaste	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.; Other: 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.
Active Comparator: Fluoridated toothpaste; 4 weeks toothbrushing with a fluoridated toothpaste	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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries remineralization	Analyis of mineral gain/loss and lesion depth by microradiography	4 weeks

Collaborators and Investigators

• Sponsor: Dr. Joachim Enax
• Investigators: Principal Investigator: Bennett T. Amaechi, Prof., The University of Texas Health Science Center at San Antonio

Publications and helpful links

General Publications

• Amaechi BT, AbdulAzees PA, Alshareif DO, Shehata MA, Lima PPCS, Abdollahi A, Kalkhorani PS, Evans V. Comparative efficacy of a hydroxyapatite and a fluoride toothpaste for prevention and remineralization of dental caries in children. BDJ Open. 2019 Dec 9;5:18. doi: 10.1038/s41405-019-0026-8. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: REHT18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No