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

ISRCTN ISRCTN04899524
DOI https://doi.org/10.1186/ISRCTN04899524
Secondary identifying numbers CPP- ACP toothpaste trial v1.2
Submission date
18/01/2014
Registration date
27/01/2014
Last edited
29/03/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
White spots on the front of the teeth are a potential side effect of fixed orthodontic brace treatment. The brackets, wires and bands reduce oral hygiene of tooth surfaces which can lead to plaque accumulation. This may result in mineral loss from the tooth surface which shows as a white spot on the tooth. This process is reduced or eliminated by effective oral hygiene and a suitable diet. Calcium-based toothpastes have been suggested as an approach to improve the damaged tooth surfaces. This study aims to find out about the re-mineralising abilities of calcium-based toothpastes.

Who can participate?
Male and female patients aged between 12 and 17 who are receiving orthodontic treatment at the University of Liverpool Dental Hospital, UK

What does the study involve?
A human enamel sample that has been demineralised in the lab will be prepared and split into three samples. Two will be used on the patient and one will be kept in the lab as a control. Mineral content will be measured in all the samples. The participant will have a carrier with the prepared enamel sample securely attached to the back part of the brace. Each participant is provided with the relevant toothpastes in a random order and provided information on brushing their teeth. In total two carriers will be attached to the brace with two different types of toothpastes to use. One of the regimes will involve brushing with a pea-sized amount of fluoride toothpaste for 2 minutes twice a day. The other regime will involve brushing with a pea-sized amount of fluoride toothpaste for 2 minutes twice a day in addition to a calcium-based toothpaste being applied to the teeth for 5 minutes twice a day.

What are the possible benefits and risks of participating?
The benefit of taking part in the study is the use of an additional toothpaste over a four-week period may help to reduce or improve areas of tooth demineralisation. The only burden to the patient will be the extra time added to their normal appointment which involves inserting and removing the sterilised enamel carrier (5 minutes). It will not affect how the brace works.

Where is the study run from?
The study will be run in the Liverpool University Dental Hospital, UK

When is the study starting and how long is it expected to run for?
The study is due to start in March 2014 and will last for approximately 5 months.

Who is funding the study?
University of Liverpool, UK

Who is the main contact?
Dr Norah Flannigan, nlf@liverpool.ac.uk
Prof Susan Higham
Mr Andrew Garry, andrew.garry@liverpool.ac.uk

Contact information

Dr Norah Flannigan
Scientific

Orthodontic Dept
Liverpool University Dental Hospital
Pembroke Place
Liverpool
L3 5PS
United Kingdom

Study information

Study designRandomized cross-over in situ study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request patient, parent and child information sheets
Scientific titleAn in situ study to determine the effects of Casein PhosphoPeptide Amorphous Calcium Phosphate toothpaste in orthodontic patients
Study acronymCPP-ACP
Study objectivesDental caries is the process of localised chemical dissolution affecting hard dental tissue due to metabolic events taking place within the surrounding biofilm. Organic acid production from bacterial fermentation of dietary sugars results in a shift in the dynamic balance of demineralisation-remineralisation with a net loss of tooth substance. This complex process is directly affected by the presence of microbial species, fermentable carbohydrates, fluoride ions, saliva composition and flow rate, buffering capacity and time. Other contributory secondary factors include education, social class, attitudes and behaviour.

This study will test the null hypothesis that there is no difference between the remineralising abilities of GC Tooth Mousse™ and normal fluoride toothpastes in orthodontic patients. Therefore there will be no statistically significant difference between volume mineral loss (ΔZ), lesion depth and lesion width.
Ethics approval(s)NRES Committee North West - Liverpool Central, REC reference: 13/NW/0742, protocol number: UoL000980, IRAS project ID: 128420
Health condition(s) or problem(s) studiedDental caries
InterventionPrepared 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 orthodontic exam
Patient provided with standard fluoride toothpaste, toothbrush and instructions

Visit 2: treatment A (4 weeks)
Routine orthodontic exam
Carrier with enamel specimen will be attached to lower premolar region
Treatment A paste is given to patient with instructions on its use

Visit 3: mid-treatment wash-out (4 weeks)
Routine orthodontic exam
Carrier with enamel specimen removed and sent for analysis
Patient provided with the standard fluoride toothpaste and instructions

Visit 4: treatment B (4 weeks)
Routine orthodontic exam
New carrier with enamel specimen attached
Treatment B pastes given to patient with instructions on its use

Visit 5: trial competition
Routine orthodontic exam
Carrier with enamel specimen removed and sent for analysis
Intervention typeOther
Primary outcome measureUsing 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 ΔZ (vol%μm)
2. Lesion depth Ld (μm) and
3. Lesion width Lw (μm)
Secondary outcome measuresAfter the trial has finished, using the previously collected data the percentage change in mineral loss, lesion depth and lesion width is calculated
Overall study start date01/03/2014
Completion date01/07/2014

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit12 Years
Upper age limit17 Years
SexBoth
Target number of participants12
Key inclusion criteriaThe 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
Key exclusion criteriaThe 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
Date of first enrolment01/03/2014
Date of final enrolment01/07/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Liverpool University Dental Hospital
Liverpool
L3 5PS
United Kingdom

Sponsor information

University of Liverpool (UK)
University/education

c/o Alex Astor
Research Support Office
2nd Floor Block D Waterhouse Building
3 Brownlow St
Liverpool
L69 3GL
England
United Kingdom

ROR logo "ROR" https://ror.org/04xs57h96

Funders

Funder type

University/education

University of Liverpool (UK) - DDSC bench fees fund
Government organisation / Universities (academic only)
Alternative name(s)
The University of Liverpool, 利物浦大学, Universidad de Liverpool, UoL
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination plan07/02/2017: Results presented in thesis 2015 https://livrepository.liverpool.ac.uk/203446
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2017 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

29/03/2018: Internal review.
19/10/2017: Publication reference added.
07/02/2017: Thesis added to publication and dissemination plan.