Orthodontic Treatment Clinical Trial
Official title:
A Randomised Controlled Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | November 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dundee Dental Hospital | Dundee | |
United Kingdom | Perth Royal Infirmary | Perth |
Lead Sponsor | Collaborator |
---|---|
University of Dundee | NHS Tayside |
United Kingdom,
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.
Morgan 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | Information on oral hygiene regimes and fluoride use during the period of fixed appliance treatment. | 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. | Week 0 | No |
Secondary | Assess severity and location of WSLs in orthodontic treatment | 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. | Week 0 | No |
Secondary | Compare ICDASii scores in different assessment techniques | 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. | 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04375540 -
Vertical Gingival Display Changes Associated With Upper Premolars Extraction
|
N/A | |
Completed |
NCT04235010 -
Genius Toothbrushes on Periodontal Status of Orthodontic Patients
|
N/A | |
Recruiting |
NCT05644119 -
Periodontal and Orthodontic Outcomes of Straight vs. Looped Fixed Retainers
|
N/A | |
Completed |
NCT04860388 -
Gingival Thickness of Impacted Maxillary Canines
|
N/A | |
Completed |
NCT03421886 -
Assessment of the Efficacy of the Aerodentis System
|
N/A | |
Completed |
NCT03187483 -
Flash-free Brackets and Dental Plaque
|
N/A | |
Completed |
NCT01268852 -
Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
|
N/A | |
Completed |
NCT03440996 -
Comparison of Three Toothpastes for the Prevention and Reduction of White Spot Lesions
|
N/A | |
Terminated |
NCT03308851 -
Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction
|
N/A | |
Completed |
NCT03446690 -
MI Varnish for the Prevention of White Spot Lesions
|
Phase 4 | |
Active, not recruiting |
NCT06436664 -
The Effects of Different Tooth Brushing Explanations in Fixed Orthodontic Treatment
|
N/A | |
Recruiting |
NCT04050657 -
Appointment Intervals and Orthodontic Tooth Movement
|
N/A | |
Completed |
NCT04549948 -
Curve of Spee: Speed of Leveling Using Different Orthodontic Archwires
|
N/A | |
Completed |
NCT02209818 -
Effect of Laser Application in Pain Management Following the Use of Orthodontic Elastomeric Separators
|
N/A | |
Completed |
NCT01320657 -
A Clinical Trial of Three Fixed Orthodontic Appliances
|
N/A | |
Recruiting |
NCT05361616 -
Impact of Photobiomodulation on Pain During Orthodontic Treatment.
|
N/A | |
Completed |
NCT05988723 -
Evaluation of the Effects of Obesity on Orthodontic Tooth Movement
|
||
Recruiting |
NCT04773210 -
Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients
|