Dental CariesNCT03956992
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
A study testing Mouth gel in people with Dental Caries, run by Dr. Joachim Enax at 1 site in Indonesia.
Trial summary
The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Mouth gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Aug 2019to 10 Aug 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Girls and boys (7-11 years)
- Visible plaque
- >= 4 teeth
- Good overall health
Who cannot join
- Allergic to one or more ingredients of the mouth gel
- Medication intake (e.g. antibiotics)
- Any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.
Read the detailed description
>= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per day); without using any other oral care product at this time. A dentist applies the gel on all teeth. At baseline and after 3 days plaque will be collected from buccal and labial surfaces (except surfaces with tartar). A "split-mouth" concept will be used:
Subjects in group A:
Baseline plaque collection: quadrant 1 and 4 Plaque collection after 3 days: quadrant 2 and 3
Subjects in group B:
Baseline plaque collection: quadrant 2 and 3 Plaque collection after 3 days: quadrant 1 and 4 (The time between last application of the gel and plaque collection will be 1 h) The plaque will be dried and afterwards the calcium content of the plaque will be quantitively analyzed by atomic absorption spectroscopy (AAS).
For all subjects: Calcium contents of plaque at baseline and after 3 days application will be compared by statistical methods.
- Conditions
- Dental Caries
- Being tested
- Mouth gel
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth gelOther
Stop using the mouth gel
| Study group | Role | What they receive |
|---|---|---|
| Mouth gel | Experimental | A mouth gel with hydroxyapatite Receives: Other: Mouth gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium content of plaque
Analysis by atomic absorption spectroscopy (AAS)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start8 Aug 2019
- Primary completion10 Aug 2019
- Study completion10 Aug 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 Dental CariesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- Henny Sudradjat, Principal investigator, Department for Dentistry, Health Care Center, Braunschweig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956992
- Sponsor's protocol ID
- Dr. Kurt Wolff
- Status last verified
- Jan 2020
- First submitted
- 17 May 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaw L, Murray JJ, Burchell CK, Best JS. Calcium and phosphorus content of plaque and saliva in relation to dental caries. Caries Res. 1983;17(6):543-8. doi: 10.1159/000260715. No abstract available.
PubMed 6580080
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
- ClinicalTrials.gov ID
- NCT03956992
- Acronym / sponsor ID
- Dr. Kurt Wolff
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dr. Joachim EnaxIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 21 May 2019 (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 aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.
Detailed description
>= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per day); without using any other oral care product at this time. A dentist applies the gel on all teeth. At baseline and after 3 days plaque will be collected from buccal and labial surfaces (except surfaces with tartar). A "split-mouth" concept will be used:
Subjects in group A:
Baseline plaque collection: quadrant 1 and 4 Plaque collection after 3 days: quadrant 2 and 3
Subjects in group B:
Baseline plaque collection: quadrant 2 and 3 Plaque collection after 3 days: quadrant 1 and 4 (The time between last application of the gel and plaque collection will be 1 h) The plaque will be dried and afterwards the calcium content of the plaque will be quantitively analyzed by atomic absorption spectroscopy (AAS).
For all subjects: Calcium contents of plaque at baseline and after 3 days application will be compared by statistical methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mouth gel | Experimental | Other: Mouth gelA mouth gel with hydroxyapatite |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Girls and boys (7-11 years)
- Visible plaque
- >= 4 teeth
- Good overall health
Key exclusion criteria (3 listed)
- Allergic to one or more ingredients of the mouth gel
- Medication intake (e.g. antibiotics)
- Any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study
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 |
|---|---|---|
| Mouth gelStop using the mouth gel | Other | Mouth gel |
Primary outcome
Calcium content of plaque
Time frame: 3 days
Analysis by atomic absorption spectroscopy (AAS)
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 30 Jan 2020.
- Background: PubMed 6580080Shaw L, Murray JJ, Burchell CK, Best JS. Calcium and phosphorus content of plaque and saliva in relation to dental caries. Caries Res. 1983;17(6):543-8. doi: 10.1159/000260715. No abstract available.
- 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.
Henny Sudradjat principal investigator
Department for Dentistry, Health Care Center, Braunschweig, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth gel in people with Dental Caries, run by Dr. Joachim Enax at 1 site in Indonesia.
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 4 inclusion and 3 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 30 Jan 2020. 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 Indonesia. 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?
Calcium content of plaque (time frame: 3 days). 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 NCT03956992, 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 30 Jan 2020.