Comparing the effects of milk and soy-based drinks on tooth enamel

Effects of soy and bovine milk beverages on enamel mineral content in a randomized, double-blind in situ clinical study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19137849

Enrollment

Registered

2019-03-18

Start date

2018-07-01

Completion date

Unknown

Last updated

2020-06-01

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

Interventions

The double-blind, randomized, cross-over in situ clinical trial was conducted at the Royal Dental Hospital of Melbourne in 2018. Participants were randomly assigned to one of the two different test p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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. Aged 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. History of severe oral disease

Design outcomes

Primary

Measure	Time frame
Integrated mineral gain/loss, ?Zd-?Zr. 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.	—

Measure

Time frame

Integrated mineral gain/loss, ?Zd-?Zr. 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.

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Secondary

Measure	Time frame
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 lesion depth (LD) as described previously (Cochrane et al. 2012). Lesion depth (LD) will be determined for the control demineralized lesion and will be designated LDd and that for the treated lesion will be designated LDr. These values will then be used to calculate the change in lesion depth will be calculated as LDd-LDr.	—

Measure

Time frame

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 lesion depth (LD) as described previously (Cochrane et al. 2012). Lesion depth (LD) will be determined for the control demineralized lesion and will be designated LDd and that for the treated lesion will be designated LDr. These values will then be used to calculate the change in lesion depth will be calculated as LDd-LDr.

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Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026