The importance of bioavailable calcium in fluoride dentifrices for tooth enamel remineralization (repair)

A double-blind, randomized, cross-over, in situ clinical trial of seven commercially available dentifrices

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13773048

Enrollment

Registered

2018-06-12

Start date

2017-06-01

Completion date

Unknown

Last updated

2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries (tooth decay) Oral Health Dental caries

Interventions

Dentifrices The dentifrices purchased for the study will include (1) Maximum Cavity Protection containing CaCO3/Arg/CaHPO4 and 1450 ppm F as Na2MFP (Colgate)

(2) Sensodyne Protect and Repair containing calcium sodium phosphosilicate (CSP, NovaMin) and 1450 ppm F as Na2MFP (GSK)

(3) Enamelon containing ACP and 1150 ppm F as SnF2 (Premier Dental)

(4) ClinPro 5000 containing TCP and 5000 ppm F as NaF (3M ESPE)

(5) MI One containing (CPP-ACP) and 1100 ppm F as NaF (GC America)

(6) 5000 ppm F as NaF control (Colgate) and (7) 1450 ppm F as NaF control (generic). The required sample size was calculated using the G*Power Version 3.1 sample size package and was based on a repe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Eight healthy adults living in Melbourne, Australia with a fluoridated (0.9 ppm F), reticulated water supply 2. Staff and students of the University of Melbourne 3. Age 18-60 years 4. At least 22 natural teeth 5. Unstimulated whole salivary flow rate of = 0.2 ml/min 6. Gum-stimulated whole salivary flow rate = 1.0 ml/min

Exclusion criteria

Exclusion criteria: 1. Currently using antibiotics or medications that may affect salivary flow rates 2. A history of severe oral disease

Design outcomes

Primary

Measure	Time frame
The effects of the dentifrices on enamel remineralization will be compared using integrated mineral gain/loss, ?Zd-?Zr, as the primary outcome measure. At the end of each treatment period each test half-slab will be paired with its control half-slab and embedded, sectioned and analysed by transverse microradiography to determine mineral content as described previously (Cochrane et al. 2012). Lesion parameters, lesion depth (LD) and integrated mineral loss (?Z) will be determined and the ?Z value for the control demineralized lesion will be designated ?Zd and that for the treated lesion will be designated ?Zr. These values will then be used to calculate total mineral loss or gain ?Zd-?Zr and percentage mineral change (%R) as (?Zd-?Zr/?Zd) x 100. The change in lesion depth will be calculated as LDd-LDr.	—

Measure

Time frame

The effects of the dentifrices on enamel remineralization will be compared using integrated mineral gain/loss, ?Zd-?Zr, as the primary outcome measure. At the end of each treatment period each test half-slab will be paired with its control half-slab and embedded, sectioned and analysed by transverse microradiography to determine mineral content as described previously (Cochrane et al. 2012). Lesion parameters, lesion depth (LD) and integrated mineral loss (?Z) will be determined and the ?Z value for the control demineralized lesion will be designated ?Zd and that for the treated lesion will be designated ?Zr. These values will then be used to calculate total mineral loss or gain ?Zd-?Zr and percentage mineral change (%R) as (?Zd-?Zr/?Zd) x 100. The change in lesion depth will be calculated as LDd-LDr.

—

Secondary

Measure	Time frame
Secondary outcome variables will be the percentage change in mineral (%R) and the change in lesion depth (LDd-LDr). At the end of each treatment period each test half-slab will be paired with its control half-slab and embedded, sectioned and analysed by transverse microradiography to determine mineral content as described previously (Cochrane et al. 2012). Lesion parameters, lesion depth (LD) and integrated mineral loss (?Z) will be determined and the ?Z value for the control demineralized lesion will be designated ?Zd and that for the treated lesion will be designated ?Zr. These values will then be used to calculate total mineral loss or gain ?Zd-?Zr and percentage mineral change (%R) as (?Zd-?Zr/?Zd) x 100. The change in lesion depth will be calculated as LDd-LDr.	—

Measure

Time frame

Secondary outcome variables will be the percentage change in mineral (%R) and the change in lesion depth (LDd-LDr). At the end of each treatment period each test half-slab will be paired with its control half-slab and embedded, sectioned and analysed by transverse microradiography to determine mineral content as described previously (Cochrane et al. 2012). Lesion parameters, lesion depth (LD) and integrated mineral loss (?Z) will be determined and the ?Z value for the control demineralized lesion will be designated ?Zd and that for the treated lesion will be designated ?Zr. These values will then be used to calculate total mineral loss or gain ?Zd-?Zr and percentage mineral change (%R) as (?Zd-?Zr/?Zd) x 100. The change in lesion depth will be calculated as LDd-LDr.

—

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026