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An in situ study to determine the effects of calcium-based toothpaste in orthodontic patients

An in situ study to determine the effects of Casein PhosphoPeptide Amorphous Calcium Phosphate toothpaste in orthodontic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04899524
Enrollment
12
Registered
2014-01-27
Start date
2014-03-01
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Dental caries Oral Health Dental caries, unspecified

Interventions

Prepared enamel lesions are placed in situ. Fluoridated toothpaste and fluoridated toothpaste plus GC ToothMousse™ will be given in a random order. Visit 1: pre-trial wash-out (4 weeks) Routine ortho

Sponsors

University of Liverpool (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The subjects are required: 1. To be between the ages of 12 to 17 years 2. To have adequate space between their last premolar and 1st standing molar to allow placement of the carrier on the archwire 3. To be in a suitable rigid archwire to allow placement of carrier 4. To be in good general health and oral health

Exclusion criteria

Exclusion criteria: The subjects will be excluded if: 1. They are allergic to milk products 2. They are taking or have taken antibiotics in the last 2 months 3. Unable to maintain adequate oral hygiene

Design outcomes

Primary

MeasureTime frame
Using Transvere MicroRadiography the mineral content of the enamel specimen will be carried out at baseline (before the trial begins) and then 4 weeks after being placed in the mouth. The following parameters will be analysed: 1. Mineral loss ?Z (vol%µm) 2. Lesion depth Ld (µm) and 3. Lesion width Lw (µm)

Secondary

MeasureTime frame
After the trial has finished, using the previously collected data the percentage change in mineral loss, lesion depth and lesion width is calculated

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026