Enamel CariesNCT04155658
Evaluation of Efficacy of Sodium Monofluorophosphate (SMPF) Toothpastes on Enamel Lesion Remineralisation
A study testing Experimental Toothpaste containing 1450ppm SMFP, Toothpaste containing 1450ppm SMFP and Toothpaste with no fluoride in people with Enamel Caries, run by Unilever R&D at 1 site in United States.
Trial summary
Double-blind, randomized, 3 group in situ study to assess effect of three toothpastes on enamel remineralization, as measured by change in integrated mineral loss (∆∆Z). The study will examine the efficacy of an experimental sodium monofluorophosphate (SMFP) toothpaste, a standard SMFP toothpaste and a negative… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Caries
- What is being tested?
- Experimental Toothpaste containing 1450ppm SMFP, Toothpaste containing 1450ppm SMFP and Toothpaste with no fluoride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to 30 Apr 2020
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be wearing a removable mandibular partial denture that fits comfortably enough to wear 24 hours a day and willing to have their partial denture modified to accommodate the enamel test specimens.
- Have completed and been accepted into the Oral Health Research Institute's screening for partial denture panel (#110007150).
- Have no current active caries or periodontal disease that may compromise the trial or health of the person. Persons exhibiting localized periodontal conditions who, in the opinion of the trial dentist, will not be negatively affected by participation in intra-oral studies may be accepted. Persons with caries may participate if the carious lesions have been restored prior to beginning the first treatment.
- Be willing to comply with all subjects' responsibilities (be willing and capable of wearing their removable partial dentures 24 hours per day during the treatment periods, attend appointments, follow brushing instructions, use non zinc adhesive in upper denture only etc.).
- Have an unstimulated salivary flow rate of at least 0.2 ml per minute as determined by a five-minute salivary flow test at screening and a stimulated salivary flow rate of at least 0.8 ml per minute as determined by a two-minute stimulated (gum base) salivary flow test at screening
Who cannot join
- Currently pregnant, intending to become pregnant during the trial period or breast-feeding.
- Have a history of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
- Have any allergy to ingredients in the trial toothpaste products.
- Currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning the first treatment.
- Have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications* that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. *Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleaning, may be accepted into the trial.
- Currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
- Currently taking fluoride supplements, required to use a fluoride mouth rinse or have received a professional fluoride treatment in the two weeks preceding specimen placement.
- Participation in another clinical trial/study within 30 days preceding the present trial/study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral Health Research Institute, Indiana University
Indianapolis, Indiana, 46202-2876
About this study
Official title: An in Situ Clinical Trial to Evaluate the Efficacy of a Calcium and Phosphate Enriched Sodium Monofluorophosphate Toothpaste on Enamel Lesion Remineralisation
Double-blind, randomized, 3 group in situ study to assess effect of three toothpastes on enamel remineralization, as measured by change in integrated mineral loss (∆∆Z). The study will examine the efficacy of an experimental sodium monofluorophosphate (SMFP) toothpaste, a standard SMFP toothpaste and a negative control toothpaste with no fluoride.
Read the detailed description
Double-blind, randomized, 3 group, in situ enamel remineralisation study. This study will accept up to 60 adult subjects who meet the inclusion/exclusion criteria in anticipation that at least 50 subjects will complete the study. All 60 subjects will have two human enamel specimens (one enamel specimen type C and one enamel specimen type N) placed in their partial denture for analysis by transverse microradiography (TMR) and of those sixty subjects, a subset will have an additional two enamel specimens (type N) placed in their partial denture for TMR measurement. All enamel specimens will have been partially demineralized using lactic acid in the laboratory prior to placement in subjects' dentures.
Subjects will receive a dental prophylaxis at the start of the trial and then brush their teeth with a fluoride-free toothpaste for the following 2 to 3 days. For the washout phase between each crossover period, subjects will return to brushing with their regular toothpaste for 4 to 5 days and then receive a dental prophylaxis and brush their teeth with a fluoride-free toothpaste for the 2 to 3 days before the next test period.
During each test period, subjects will be asked to brush with their allocated toothpaste at home twice daily for 4 weeks taking care to not brush the enamel specimens. The brushing procedure will be performed at home each morning following breakfast and right before going to bed on each evening. Subjects must wear their partial denture for 24 hours a day during the test phase.
At final visit of each test period, subjects will be instructed to brush their teeth with the randomly assigned trial toothpaste. Enamel specimens will be removed from denture and transferred to analyst for laboratory analyses.
- Conditions
- Enamel Caries
- Being tested
- Experimental Toothpaste containing 1450ppm SMFP, Toothpaste containing 1450ppm SMFP, Toothpaste with no fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Toothpaste containing 1450ppm SMFPOther
Experimental Toothpaste containing 1450ppm SMFP
Toothpaste containing 1450ppm SMFPOther
Toothpaste containing 1450ppm SMFP
Toothpaste with no fluorideOther
Toothpaste with no fluoride
| Study group | Role | What they receive |
|---|---|---|
| Experimental SMFP Toothpaste | Experimental | Toothpaste containing 1450ppm SMFP with additional calcium and phosphate Receives: Other: Experimental Toothpaste containing 1450ppm SMFP |
| SMFP Toothpaste | Active comparator | Toothpaste containing 1450ppm SMFP Receives: Other: Toothpaste containing 1450ppm SMFP |
| Negative control toothpaste | Placebo comparator | Toothpaste with no fluoride Receives: Other: Toothpaste with no fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in integrated mineral loss from baseline ∆∆Z (enamel specimen type N)
Calculation of Integrated Mineral Loss ∆Z = [(lesion depth x 87) - area under the curve] where 'area under the curve' relates volume % mineral at distances from the enamel specimen surface with respect to enamel section thickness, measured using transverse microradiography (TMR)
Measured: Baseline to 4 weeks
Secondary outcomes (1)
Change in integrated mineral loss ∆∆Z (enamel specimen type C)
Calculation of Integrated Mineral Loss ∆Z = [(lesion depth x 87) - area under the curve] where 'area under the curve' relates volume % mineral at distances from the enamel specimen surface with respect to enamel section thickness, measured using transverse microradiography (TMR)
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start25 Nov 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Domenick T Zero, DDS, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155658
- Sponsor's protocol ID
- ORL-IST-3324
- Status last verified
- May 2020
- First submitted
- 5 Nov 2019
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An in Situ Clinical Trial to Evaluate the Efficacy of a Calcium and Phosphate Enriched Sodium Monofluorophosphate Toothpaste on Enamel Lesion Remineralisation
- ClinicalTrials.gov ID
- NCT04155658
- Acronym / sponsor ID
- ORL-IST-3324
- Conditions
- Enamel Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 7 Nov 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.
Double-blind, randomized, 3 group in situ study to assess effect of three toothpastes on enamel remineralization, as measured by change in integrated mineral loss (∆∆Z). The study will examine the efficacy of an experimental sodium monofluorophosphate (SMFP) toothpaste, a standard SMFP toothpaste and a negative control toothpaste with no fluoride.
Detailed description
Double-blind, randomized, 3 group, in situ enamel remineralisation study. This study will accept up to 60 adult subjects who meet the inclusion/exclusion criteria in anticipation that at least 50 subjects will complete the study. All 60 subjects will have two human enamel specimens (one enamel specimen type C and one enamel specimen type N) placed in their partial denture for analysis by transverse microradiography (TMR) and of those sixty subjects, a subset will have an additional two enamel specimens (type N) placed in their partial denture for TMR measurement. All enamel specimens will have been partially demineralized using lactic acid in the laboratory prior to placement in subjects' dentures.
Subjects will receive a dental prophylaxis at the start of the trial and then brush their teeth with a fluoride-free toothpaste for the following 2 to 3 days. For the washout phase between each crossover period, subjects will return to brushing with their regular toothpaste for 4 to 5 days and then receive a dental prophylaxis and brush their teeth with a fluoride-free toothpaste for the 2 to 3 days before the next test period.
During each test period, subjects will be asked to brush with their allocated toothpaste at home twice daily for 4 weeks taking care to not brush the enamel specimens. The brushing procedure will be performed at home each morning following breakfast and right before going to bed on each evening. Subjects must wear their partial denture for 24 hours a day during the test phase.
At final visit of each test period, subjects will be instructed to brush their teeth with the randomly assigned trial toothpaste. Enamel specimens will be removed from denture and transferred to analyst for laboratory analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental SMFP Toothpaste | Experimental | Other: Experimental Toothpaste containing 1450ppm SMFPToothpaste containing 1450ppm SMFP with additional calcium and phosphate |
| SMFP Toothpaste | Active comparator | Other: Toothpaste containing 1450ppm SMFPToothpaste containing 1450ppm SMFP |
| Negative control toothpaste | Placebo comparator | Other: Toothpaste with no fluorideToothpaste with no fluoride |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be wearing a removable mandibular partial denture that fits comfortably enough to wear 24 hours a day and willing to have their partial denture modified to accommodate the enamel test specimens.
- Have completed and been accepted into the Oral Health Research Institute's screening for partial denture panel (#110007150).
- Have no current active caries or periodontal disease that may compromise the trial or health of the person. Persons exhibiting localized periodontal conditions who, in the opinion of the trial dentist, will not be negatively affected by participation in intra-oral studies may be accepted. Persons with caries may participate if the carious lesions have been restored prior to beginning the first treatment.
- Be willing to comply with all subjects' responsibilities (be willing and capable of wearing their removable partial dentures 24 hours per day during the treatment periods, attend appointments, follow brushing instructions, use non zinc adhesive in upper denture only etc.).
- Have an unstimulated salivary flow rate of at least 0.2 ml per minute as determined by a five-minute salivary flow test at screening and a stimulated salivary flow rate of at least 0.8 ml per minute as determined by a two-minute stimulated (gum base) salivary flow test at screening
Key exclusion criteria (8 listed)
- Currently pregnant, intending to become pregnant during the trial period or breast-feeding.
- Have a history of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
- Have any allergy to ingredients in the trial toothpaste products.
- Currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning the first treatment.
- Have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications* that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. *Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleaning, may be accepted into the trial.
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 |
|---|---|---|
| Experimental Toothpaste containing 1450ppm SMFPExperimental Toothpaste containing 1450ppm SMFP | Other | Experimental SMFP Toothpaste |
| Toothpaste containing 1450ppm SMFPToothpaste containing 1450ppm SMFP | Other | SMFP Toothpaste |
| Toothpaste with no fluorideToothpaste with no fluoride | Other | Negative control toothpaste |
Primary outcome
Change in integrated mineral loss from baseline ∆∆Z (enamel specimen type N)
Time frame: Baseline to 4 weeks
Calculation of Integrated Mineral Loss ∆Z = [(lesion depth x 87) - area under the curve] where 'area under the curve' relates volume % mineral at distances from the enamel specimen surface with respect to enamel section thickness, measured using transverse microradiography (TMR)
1 secondary outcome
Change in integrated mineral loss ∆∆Z (enamel specimen type C)
Time frame: Baseline to 4 weeks
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 18 May 2020.
- Individual participant dataSharing planned: No
Related trials for Enamel Caries
Recruiting
Nano-Silver Versus Bioactive Glass for Primary Teeth Exposed to Therapeutic Radiation
Radiation Caries
Not yet recruitingPhase 4
Enamel Lesion Detection With New DX Tool
Enamel Lesions, Caries
Active, not recruiting
Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth
Molar-Incisor Hypomineralization (MIH)
Recruiting
Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries
Initial Dental Caries
Active, not recruiting
Zirconia and Bioflx Crowns for Primary Anterior Teeth
Dental Caries, Tooth Hypomineralization
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.
Domenick T Zero, DDS, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Toothpaste containing 1450ppm SMFP, Toothpaste containing 1450ppm SMFP and Toothpaste with no fluoride in people with Enamel Caries, run by Unilever R&D 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 5 inclusion and 8 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 18 May 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 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. Some participants in this study may receive a placebo. 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?
Change in integrated mineral loss from baseline ∆∆Z (enamel specimen type N) (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2020.