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The repair of early tooth decay using a combination of stannous fluoride and a calcium milk peptide complex

The effect of rinsing with solutions containing sodium fluoride or stannous fluoride with and without casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on remineralisation of enamel subsurface lesions in situ

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10532332
Enrollment
8
Registered
2018-11-23
Start date
2014-05-20
Completion date
Unknown
Last updated
2019-01-14

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

The in situ study will be a randomised, controlled, double-blind cross-over study design. Artificially demineralised carious lesions were created on enamel blocks sectioned from human third molars and
Shen et al. 2018). Eight healthy subjects with an average age of 43 ± 11 years old (four males and four females) participated. It was calculated that eight participants was required to provide the req
Shen et al. 2018
Walker et al. 2010). The required sample size was calculated using the G*Power Version 3.1 sample size package (Faul et al. 2007) and was based on a repeated measures analysis of variance with five le

Sponsors

University of Melbourne
Lead Sponsor

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

MeasureTime frame
The effects of the rinses on enamel remineralization will be compared using integrated mineral gain/loss (?Zd-?Zr/%R) 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

MeasureTime frame
The profile levels of fluoride and tin in enamel lesions remineralised measured using Electron Probe Microanalysis following exposure to the five solutions

Countries

Australia

Outcome results

None listed

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