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Remineralization Effects of Hydroxyapatite Toothpaste

Primary Purpose

Caries, Dental

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hydroxyapatite toothpaste

Fluoridated toothpaste

About this trial

This is an interventional prevention trial for Caries, Dental

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydroxyapatite toothpaste

Fluoridated toothpaste

Arm Description

4 weeks toothbrushing with a hydroxyapatite toothpaste

4 weeks toothbrushing with a fluoridated toothpaste

Outcomes

Primary Outcome Measures

Caries remineralization

Analyis of mineral gain/loss and lesion depth by microradiography

Secondary Outcome Measures

Full Information

NCT ID

NCT03681340

First Posted

September 20, 2018

Last Updated

July 19, 2019

Sponsor

Dr. Joachim Enax

1. Study Identification

Unique Protocol Identification Number

NCT03681340

Brief Title

Remineralization Effects of Hydroxyapatite Toothpaste

Official Title

Investigation of the Caries Prevention and Remineralization Effects of Hydroxyapatite Toothpaste

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

August 7, 2018 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Joachim Enax

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Caries, Dental

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydroxyapatite toothpaste

Arm Type

Experimental

Arm Description

4 weeks toothbrushing with a hydroxyapatite toothpaste

Arm Title

Fluoridated toothpaste

Arm Type

Active Comparator

Arm Description

4 weeks toothbrushing with a fluoridated toothpaste

Intervention Type

Other

Intervention Name(s)

Hydroxyapatite toothpaste

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Fluoridated toothpaste

Intervention Description

Primary Outcome Measure Information:

Title

Caries remineralization

Description

Analyis of mineral gain/loss and lesion depth by microradiography

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bennett T. Amaechi, Prof.

Organizational Affiliation

The University of Texas Health Science Center at San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3900

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31839988

Citation

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.

Results Reference

derived

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Remineralization Effects of Hydroxyapatite Toothpaste

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