Caries, DentalNCT03681340
Remineralization Effects of Hydroxyapatite Toothpaste
A study testing Hydroxyapatite toothpaste and Fluoridated toothpaste in people with Caries, Dental, run by Dr. Joachim Enax at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- Hydroxyapatite toothpaste and Fluoridated toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: 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.
Read the 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
- Conditions
- Caries, Dental
- Being tested
- Hydroxyapatite toothpaste, Fluoridated toothpaste
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyapatite toothpasteOther
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 toothpasteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyapatite toothpaste | Experimental | 4 weeks toothbrushing with a hydroxyapatite toothpaste Receives: Other: Hydroxyapatite toothpaste; Other: Fluoridated toothpaste |
| Fluoridated toothpaste | Active comparator | 4 weeks toothbrushing with a fluoridated toothpaste Receives: Other: Hydroxyapatite toothpaste; Other: Fluoridated toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries remineralization
Analyis of mineral gain/loss and lesion depth by microradiography
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start7 Aug 2018
- Primary completion1 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Joachim Enax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Dr. Joachim Enax, Dr. Kurt Wolff GmbH & Co. KG
- Investigators
- Bennett T. Amaechi, Prof., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681340
- Sponsor's protocol ID
- REHT18
- Status last verified
- Jul 2019
- First submitted
- 20 Sep 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31839988
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Caries Prevention and Remineralization Effects of Hydroxyapatite Toothpaste
- ClinicalTrials.gov ID
- NCT03681340
- Acronym / sponsor ID
- REHT18
- Conditions
- Caries, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dr. Joachim EnaxIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxyapatite toothpaste | Experimental | Other: Hydroxyapatite toothpaste, Other: Fluoridated toothpaste4 weeks toothbrushing with a hydroxyapatite toothpaste |
| Fluoridated toothpaste | Active comparator | Other: Hydroxyapatite toothpaste, Other: Fluoridated toothpaste4 weeks toothbrushing with a fluoridated toothpaste |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyapatite toothpasteIf 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, Hydroxyapatite toothpaste |
| Fluoridated toothpasteIf 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, Hydroxyapatite toothpaste |
Primary outcome
Caries remineralization
Time frame: 4 weeks
Analyis of mineral gain/loss and lesion depth by microradiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Derived from this study: PubMed 31839988Amaechi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bennett T. Amaechi, Prof. principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyapatite toothpaste and Fluoridated toothpaste in people with Caries, Dental, run by Dr. Joachim Enax at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries remineralization (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03681340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.