A Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions
A Randomised Controlled Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions
1 other identifier
interventional
90
1 country
2
Brief Summary
Fixed dental braces are associated with the risk of developing White Spot Lesions (WSLs), which appear as white chalky marks on the teeth. They develop as a result of the acid produced by bacteria in dental plaque dissolving the outer surface of the tooth, known as demineralisation. Recently, amorphous calcium phosphate (ACP) stabilised by casein phosphopeptide (CPP) has become available, and it is reported to help rebuild the surface of teeth which have WSLs. CPP-ACP is available incorporated into a crème known as Tooth Mousse (TM). While there appears to be sufficient evidence regarding the use of CPP-ACP in promoting general remineralisation, for the first time this study aims to examine the use of CPP-ACP to treat WSLs in post-orthodontic participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 13, 2014
January 1, 2014
2.4 years
April 7, 2011
January 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effectiveness of TM to promote remineralisation of WSLs
To determine the effectiveness of TM to promote remineralisation of WSLs in post orthodontic treatment study patients. Patients will be reviewed at 6 weeks and 12 weeks. At both visits WSLs will be reassessed and categorised by a calibrated examiner using the International Caries Detection and Assessment System (ICDASii) for scoring lesions. Examiner reliability will be determined by scoring extracted teeth and teeth validated by histology. Intra-oral photographs will also be taken of each participant and the photographs analysed by two different blinded ICDASii calibrated examiners.
12 weeks
Participants' perception of the appearance of their WSLs
To determine the change in study participants' perceptions of the appearance of their WSLs after using TM or no TM in their orthodontic retainers. Patients will be asked to score their own perception of the appearance of their teeth, considering the presence of their WSLs, using a Visual Analogue Score (VAS).
12 weeks
Secondary Outcomes (3)
Information on oral hygiene regimes and fluoride use during the period of fixed appliance treatment.
Week 0
Assess severity and location of WSLs in orthodontic treatment
Week 0
Compare ICDASii scores in different assessment techniques
12 weeks
Study Arms (2)
Casein phosphopeptide in the form of TM
EXPERIMENTALExperimental group will be given TM to use daily for 12 weeks
No intervention
NO INTERVENTIONStandard oral care
Interventions
TM is a water based creme containing RECALDENT. RECALDENT consists of CPP-AP: Casein Phosphopeptide - Amorphous Calcium Phosphate.
Eligibility Criteria
You may qualify if:
- Single or both arch fixed orthodontic appliance treatment completed
- Being provided with a vacuum formed retainer(s)
- Participant, or parent or guardian of participant if less than 12 years, gives written informed consent
You may not qualify if:
- Tooth Mousse used during orthodontic treatment
- Having a bonded retainer
- Not receiving a vacuum formed retainer
- Suffers from psychiatric or behavioural problems which may affect ability to follow study instructions
- Resting salivary flow rate less than 0.2ml/minute
- Stimulated salivary flow rate less than 1.0ml/minute
- Allergic to milk proteins or benzoate derivatives
- Unable to read and understand PIL, ICF and questionnaires
- Taking medication which may affect salivary flow
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Taysidecollaborator
- University of Dundeelead
Study Sites (2)
Dundee Dental Hospital
Dundee, DD1 4HN, United Kingdom
Perth Royal Infirmary
Perth, PH1 1NX, United Kingdom
Related Publications (2)
Manton DJ, Shen P, Cai F, Cochrane NJ, Reynolds C, Messer LB, Reynolds EC. Remineralisation of WSLs in situ by TM. (Abstract) IADR 84th General Session, Brisbane 2006.
BACKGROUNDMorgan MV, Bailey D, Adams G, Tsao C, Hyslop A, Escobar K, Manton DJ, Reynolds E. A clinical study measuring white spot lesion progression and regression. (Abstract) J Dent Res 2008: 87 (special issue B): 11-4
BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
David Bearn, M(Orth)RCS PhD BDS
University of Dundee
- PRINCIPAL INVESTIGATOR
Louise Greene, MFDS BDS
NHS Tayside
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- TCTU Assistant Director
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 29, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2013
Study Completion
November 1, 2013
Last Updated
January 13, 2014
Record last verified: 2014-01