A Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions
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|ClinicalTrials.gov Identifier: NCT01344473|
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : January 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Demineralisation White Spot Lesions Orthodontic Treatment||Device: Tooth Mousse creme (Casein Phosphopeptide)(RECALDENT)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomised Controlled Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||November 2013|
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
- Effectiveness of TM to promote remineralisation of WSLs [ Time Frame: 12 weeks ]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 ]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).
- Information on oral hygiene regimes and fluoride use during the period of fixed appliance treatment. [ Time Frame: Week 0 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344473
|Dundee Dental Hospital|
|Dundee, United Kingdom, DD1 4HN|
|Perth Royal Infirmary|
|Perth, United Kingdom, PH1 1NX|
|Principal Investigator:||David Bearn, M(Orth)RCS PhD BDS||University of Dundee|
|Principal Investigator:||Louise Greene, MFDS BDS||NHS Tayside|