Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01344473
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2011-04-07
Brief Title:
A Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions
Sponsor:
University of Dundee
Organization:
University of Dundee
Study Overview
Official Title:
A Randomised Controlled Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The study will be run in the Orthodontic departments of Dundee Dental School and Perth Royal Infirmary both in NHS Tayside The investigators will recruit a total of 80 participants to the study Clinicians within the orthodontic departments will determine when a patient could be a potential participant of the study and one visit prior to debonding of their brace the treating clinician will discuss the study with the potential participant If they are interested in finding out more the clinician will issue the potential participant with the appropriate PIL There will be a PIL for potential participants over sixteen years old and separate PILs for those aged twelve to sixteen years old under twelve years old and for parentsguardians of potential participants under sixteen years old The clinician will then inform the PISI that a PIL and supporting documentation has been issued There will be a potential participant referral form which can be completed to aid the transfer of information to the PISI Potential participants under twelve years old will be advised that a parent or guardian must attend with them for the debond appointment when written informed consent IC will be sought from the parentsguardians by the Investigators of the study
Once IC has been obtained resting and stimulated salivary flow rate will be measured by the Investigators or delegated member of the research team using a Saliva-Check Buffer kit GC Corp Leuven Belgium The kit will allow observation of the quantity and viscosity of resting saliva produced in one minute and the pH of the sample will also be tested and recorded Participants will then chew a piece of paraffin wax for a two-minute period to produce a stimulated salivary sample The liquid component of the sample will be measured to allow a flow rate in mlminute to be calculated and the pH again tested and recorded The buffering capacity of the stimulated saliva will also be determined by challenging the saliva with varying amounts of lactic acid As a lack of saliva would bias the results for the study due to increased caries risk and as saliva is essential for the hydrolysis of the CPP-ACP from the TM if the resting salivary flow rate is below 02mlmin or the stimulated rate below 10mlmin then the subject will be excluded from the study Participants will then be randomly allocated to the control or the experimental group
Each subject included in the study will have their WSLs assessed and categorised clinically using the International Caries Detection and Assessment System ICDASii International Caries Detection and Assessment System Coordinating Committee 2009a by ICDASii calibrated examiners Examiner reliability will be determined by scoring extracted teeth and teeth validated by histology Reproducibility will be measured using Kappa scores All lesions on the buccal surfaces of teeth will be included in the study Intra-oral digital photographs will also be taken of each participant in a reproducible manner and the photographs analysed by two different blinded ICDASii calibrated examiners who will be recruited to the study simply to score the clinical photographs A colour standard CasMaTCH Bear medic Tokyo will be used to allow colour matching of the images
The experimental group will receive TM crème to use daily The oral and written instructions regarding crème application will be provided indicating that the crème should be applied to all surfaces of the teeth agitated swished for one minute and then retainers placed for night-time wear as per crème application protocol
Subjects in the control group will not use any crème in their retainers but will simply be asked to place their retainer for night-time wear
At commencement of the study 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 eg visits to hygienist topical fluoride application during their fixed appliance treatment The participants dental records will be reviewed and any record of pre-existing developmental defects of enamel or WSLs will be documented Participants will be asked to score their own perception of the appearance of their teeth considering the presence of their WSLs using a validated Visual Analogue Scale VAS
Participants will be reviewed at 6 weeks and at 12 weeks At both visits WSLs will be reassessed and categorised by a calibrated examiner PISI using ICDASii Digital photographs will be retaken for analysis by other blinded calibrated examiners and the where appropriate the participants will be asked to bring their tube of unused crème to be weighed to help determine compliance to the study protocol A decision has been made not to issue subject diaries to determine compliance as evidence in the Orthodontic literature hasnt found self-reporting of this type in this area to be reliable Participants will be asked to score the appearance of their teeth using the VAS again and subjects in the experimental group will complete a questionnaire on acceptability taste and convenience of using the crème
A transition matrix incorporating ICDASii severity and activity scores will be used to assess the stability regression or progression of WSLs between baseline and follow-up examinations
Once IC has been obtained resting and stimulated salivary flow rate will be measured by the Investigators or delegated member of the research team using a Saliva-Check Buffer kit GC Corp Leuven Belgium The kit will allow observation of the quantity and viscosity of resting saliva produced in one minute and the pH of the sample will also be tested and recorded Participants will then chew a piece of paraffin wax for a two-minute period to produce a stimulated salivary sample The liquid component of the sample will be measured to allow a flow rate in mlminute to be calculated and the pH again tested and recorded The buffering capacity of the stimulated saliva will also be determined by challenging the saliva with varying amounts of lactic acid As a lack of saliva would bias the results for the study due to increased caries risk and as saliva is essential for the hydrolysis of the CPP-ACP from the TM if the resting salivary flow rate is below 02mlmin or the stimulated rate below 10mlmin then the subject will be excluded from the study Participants will then be randomly allocated to the control or the experimental group
Each subject included in the study will have their WSLs assessed and categorised clinically using the International Caries Detection and Assessment System ICDASii International Caries Detection and Assessment System Coordinating Committee 2009a by ICDASii calibrated examiners Examiner reliability will be determined by scoring extracted teeth and teeth validated by histology Reproducibility will be measured using Kappa scores All lesions on the buccal surfaces of teeth will be included in the study Intra-oral digital photographs will also be taken of each participant in a reproducible manner and the photographs analysed by two different blinded ICDASii calibrated examiners who will be recruited to the study simply to score the clinical photographs A colour standard CasMaTCH Bear medic Tokyo will be used to allow colour matching of the images
The experimental group will receive TM crème to use daily The oral and written instructions regarding crème application will be provided indicating that the crème should be applied to all surfaces of the teeth agitated swished for one minute and then retainers placed for night-time wear as per crème application protocol
Subjects in the control group will not use any crème in their retainers but will simply be asked to place their retainer for night-time wear
At commencement of the study 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 eg visits to hygienist topical fluoride application during their fixed appliance treatment The participants dental records will be reviewed and any record of pre-existing developmental defects of enamel or WSLs will be documented Participants will be asked to score their own perception of the appearance of their teeth considering the presence of their WSLs using a validated Visual Analogue Scale VAS
Participants will be reviewed at 6 weeks and at 12 weeks At both visits WSLs will be reassessed and categorised by a calibrated examiner PISI using ICDASii Digital photographs will be retaken for analysis by other blinded calibrated examiners and the where appropriate the participants will be asked to bring their tube of unused crème to be weighed to help determine compliance to the study protocol A decision has been made not to issue subject diaries to determine compliance as evidence in the Orthodontic literature hasnt found self-reporting of this type in this area to be reliable Participants will be asked to score the appearance of their teeth using the VAS again and subjects in the experimental group will complete a questionnaire on acceptability taste and convenience of using the crème
A transition matrix incorporating ICDASii severity and activity scores will be used to assess the stability regression or progression of WSLs between baseline and follow-up examinations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None