Remineralization Effects of Hydroxyapatite Toothpaste

NCT03681340 | Completed

• 1 other identifier: REHT18
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries, Dental

Outcome Measures

Primary Outcomes (1)

• Caries remineralization

  Analyis of mineral gain/loss and lesion depth by microradiography

  4 weeks

Study Arms (2)

Hydroxyapatite toothpaste

EXPERIMENTAL

4 weeks toothbrushing with a hydroxyapatite toothpaste

Other: Hydroxyapatite toothpaste; Other: Fluoridated toothpaste

Fluoridated toothpaste

ACTIVE COMPARATOR

4 weeks toothbrushing with a fluoridated toothpaste

Other: Hydroxyapatite toothpaste; Other: Fluoridated toothpaste

Interventions

Hydroxyapatite toothpaste OTHER

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; Hydroxyapatite toothpaste

Fluoridated toothpaste OTHER

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; Hydroxyapatite toothpaste

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Dr. Joachim Enax: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (1)

• 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.

  PMID: 31839988 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bennett T. Amaechi, Prof.

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: August 7, 2018
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)