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A Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions

This study is currently recruiting participants.
Verified April 2012 by University of Dundee
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
Fiona Hogarth, University of Dundee
ClinicalTrials.gov Identifier:
NCT01344473
First received: April 7, 2011
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Demineralisation
White Spot Lesions
Orthodontic Treatment
 Device: Tooth Mousse creme (Casein Phosphopeptide)(RECALDENT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions

Resource links provided by NLM:

MedlinePlus related topics: Orthodontia Rashes
Drug Information available for: Casein
U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Effectiveness of TM to promote remineralisation of WSLs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Participants' perception of the appearance of their WSLs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Information on oral hygiene regimes and fluoride use during the period of fixed appliance treatment. [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    This outcome aims to obtain information on oral hygiene regimes and fluoride use during fixed appliance treatment of study participants who exhibit WSLs at the end of fixed appliance treatment. At the time of recruitment, it will be recorded how long participants' fixed appliances had been in situ and all participants and clinicians will receive a questionnaire to determine their fluoride use, oral hygiene regime, diet and preventive interventions e.g. visits to hygienist etc during their fixed appliance treatment.

  • Assess severity and location of WSLs in orthodontic treatment [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    At the time of recruitment, and immediatly after removal of their fixed appliance, the participants will have the severity and location of their WSLs assessed and categorised clinically using the ICDASii calibrated examiners. All lesions on the buccal surfaces of the teeth will be included in the study. Intra-oral digital photographs will also be taken of each participant and the photographs analysed by two different blinded ICDASii calibrated examiners.

  • Compare ICDASii scores in different assessment techniques [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To compare the ICDASii scores of WSLs determined clinically with ICDASii scores of the same WSLs determined using digital photography 6 weeks and 12 weeks after debond of their appliance.


Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Casein phosphopeptide in the form of TM
Experimental group will be given TM to use daily for 12 weeks
 Device: Tooth Mousse creme (Casein Phosphopeptide)(RECALDENT)
TM is a water based creme containing RECALDENT. RECALDENT consists of CPP-AP: Casein Phosphopeptide - Amorphous Calcium Phosphate.
Other Name: RECALDENT
No Intervention: No intervention
Standard oral care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344473

Contacts
Contact: David Bearn, M(Orth)RCS PhD BDS +44(0)1382 635978 d.bearn@dundee.ac.uk
Contact: Louise Greene, MFDS BDS +44(0)1382 635964 louise.greene@nhs.net

Locations
United Kingdom
Dundee Dental Hospital Recruiting
Dundee, United Kingdom, DD1 4HN
Contact: David Bearn, M(Orth)RCS PhD BDS     +44(0)1382 635978     d.bearn@dundee.ac.uk    
Contact: Louise Greene, MFDS BDS     +44(0)1382 635964     louise.greene@nhs.net    
Principal Investigator: David Bearn, M(Orth)RCS PhD BDS            
Sub-Investigator: Louise Greene, MFDS BDS            
Perth Royal Infirmary Recruiting
Perth, United Kingdom, PH1 1NX
Contact: Bearn David, FDS RCPS MRCS PhD MSc BDS     +44(0)1382 635978     d.bearn@dundee.ac.uk    
Contact: Greene Louise, MFDS BDS     +44(0)1382 635964        
Principal Investigator: David Bearn, M(Orth)RCS PhD BDS            
Sub-Investigator: Louise Greene, MFDS BDS            
Sponsors and Collaborators
University of Dundee
NHS Tayside
Investigators
Principal Investigator: David Bearn, M(Orth)RCS PhD BDS University of Dundee
Principal Investigator: Louise Greene, MFDS BDS NHS Tayside
  More Information

No publications provided

Responsible Party: Fiona Hogarth, TCTU Assistant Director, University of Dundee
ClinicalTrials.gov Identifier: NCT01344473     History of Changes
Obsolete Identifiers: NCT01631734
Other Study ID Numbers: 2010DE11
Study First Received: April 7, 2011
Last Updated: April 17, 2012
Health Authority: United Kingdom: University of Dundee
United Kingdom: NHS Tayside

Keywords provided by University of Dundee:
Remineralisation
White Spot Lesions
Orthodontic treatment
Tooth Mousse creme
Casein Phosphopeptide

Additional relevant MeSH terms:
Exanthema
Dental Caries
Skin Diseases
Tooth Demineralization
Tooth Diseases
 Stomatognathic Diseases
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013