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

NCT01344473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-01-13

No results posted yet for this study

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.

Conditions

  • Demineralisation
  • White Spot Lesions
  • Orthodontic Treatment

Interventions

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.

Sponsors & Collaborators

  • NHS Tayside

    collaborator OTHER_GOV
  • University of Dundee

    lead OTHER

Principal Investigators

  • David Bearn, M(Orth)RCS PhD BDS · University of Dundee

  • Louise Greene, MFDS BDS · NHS Tayside

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-08-31
Completion
2013-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344473 on ClinicalTrials.gov