Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01059058
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2010-01-27
Brief Title:
Study of Treatments Used for White Spot Lesions After Orthodontic Treatment
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Treatment of White Spot Lesions After Orthodontic Treatment A Practice-based Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-08
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:
The purpose of this study is to learn more about the management of white spot lesions that occur after orthodontic treatment White spot lesions generally improve slightly with time To date there is no proven method to help white spot lesions improve faster Two treatments called MI Paste Plus and fluoride varnish have shown some potential benefits in a laboratory setting but have not undergone testing in a clinical setting Approximately 240 subjects are to be enrolled in this study The study will take place in approximately 30 dental and orthodontic offices across Idaho Montana Oregon Utah and Washington as part of Northwest PRECEDENT a five-state research network that was created to study the practical issues facing dentistsorthodontists and their patients and to provide information that will improve the quality of oral health care as a whole Researchers at the University of Washington and Oregon Health Science University share management and oversight of the network and research projects
Detailed Description:
White spot lesions WSL caused by the decalcification of enamel are a common and unfortunate sequela of orthodontic treatment If not addressed WSL may progress to caries and frank cavitation of the enamel surface Once formed white spot lesions compromise esthetics and can be extremely difficult or even impossible to reverse Many clinicians consider a high-dose fluoride application to be the first step in treatment of WSL in order to arrest areas of decalcification However some believe that while remineralization with high levels of fluoride may repair the surface of enamel it may possibly block remineralization of the deeper areas of enamel This in turn may hamper efforts to normalize the appearance of WSL
Casein phosphopeptide-amorphous calcium phosphate CPP-ACP containing products are a recently proposed therapy for the treatment of white spots following orthodontic treatment CPP is thought to stabilize and localize calcium fluoride and phosphate at the tooth surface in a slow-release amorphous form thus enhancing deeper remineralization of WSL Products containing CPP-ACP are currently marketed under various names including MI Paste Plus which also contains fluoride Few in vivo studies have investigated the effectiveness of various remineralization products to address WSL after orthodontics This project is a single-blind randomized clinical trial with three arms - MI Paste Plus for an 8-week duration a single application of Duraphat Fluoride Varnish with reassessment at 8 weeks and normal home care for an 8 week period Subjects will be recruited at their regularly scheduled orthodontic appointments with eligible subjects being up to 2 years post-removal of fixed orthodontic appliances
This project is intended to answer four questions regarding the management of white spot lesions
Specific Aim 1 to compare the effectiveness MI Paste Plus and Duraphat Fluoride Varnish to a standard oral hygienetoothpaste regimen in improving the appearance of WSL after orthodontic treatment
Specific Aim 2 to investigate subjects self-assessment of improvement in each of the three arms
Specific Aim 3 to investigate variables such as age gender time since fixed orthodontic appliance removal compliance oral hygiene practices etc that may influence WSL improvement
Specific Aim 4 to investigate the short-term changes in WSL from the day of orthodontic appliance removal until the day of retainer delivery usually 2 - 7 days
This study will provide valuable evidence on the management of WSL after orthodontic treatment As previously stated WSL lesions are quite common and difficult to reverse so it is important to conduct rigorous clinical research in an effort to develop effective strategies
This study will be a randomized clinical trial NW PRECEDENT providers will invite subjects to participate if they are between the ages of 12 and 20 and have at least one new WSL on the 4 maxillary incisors associated with orthodontic treatment These are the most common teeth to develop these lesions The NW PRECEDENT provider must verify that the WSL were not present in the pre-orthodontic treatment records Subjects must be willing to be placed into any of the following three groups
1 Test Group A 10 CPP-ACP 900 ppm Fluoride paste - a trained staff member from the NW PRECEDENT dentalorthodontic office will give 3 tubes of MI Paste Plus and instructions to the subject for home use The subjects will also receive non-prescription fluoride toothpaste 1100 ppm Fluoride and oral hygiene instructions The group will consist of 80 subjects and each subject will be given enough MI Paste for the duration of the trial Treatment will begin on the day of retainer delivery if the subject was recruited on the day of fixed appliance removal Otherwise the treatment will begin on the date of recruitment
2 Test Group B Fluoride Varnish Group - a trained staff member from the NW PRECEDENT dentalorthodontic office will provide a single fluoride varnish application 22600 ppm Fluoride to the subject The subjects will also receive non-prescription fluoride toothpaste 1100 ppm Fluoride and oral hygiene instructions The group will consist of 80 subjects Treatment will begin on the day of retainer delivery if the subject was recruited on the day of fixed appliance removal Otherwise the treatment will begin on the date of recruitment
3 Control Group - These 80 subjects will receive non-prescription fluoride toothpaste 1100 ppm Fluoride and oral hygiene instructions at the time of enrollment After the trial is completed August 2011 these subjects will be informed of the results and offered one of the two active arms if they are found to be effective in reducing WSL
The NW PRECEDENT provider and the subject will also fill out a short survey to compile information about the subjects age gender race ethnicity time in fixed appliances oral hygiene during treatment and type of retainers after orthodontic treatment Upon determining a subjects eligibility and willingness to participate as well as obtaining assentconsent heshe will be randomly assigned to a group a baseline photograph will be taken and the assigned treatment will begin In the case of subjects who have just had their orthodontic appliances removed the subjects will undergo enrollment and photos but their assigned treatment will not begin until the day of retainer delivery The subjects general dentist if they did not perform their orthodontic care will be sent a letter informing them that their patients are currently enrolled in the study and that any additional treatment for white spot lesions should be delayed until the study is complete 8 weeks
Subjects who are identified at some time after their fixed orthodontic appliances have been removed will have baseline photographs taken on the day of recruitment Subjects who are identified on the day their appliances are removed will have photographs taken on that day as well at the time of retainer delivery 2 - 7 days later A subsequent analysis of the day of fixed appliance removal and one week follow-up photographs will be performed in order to determine if significant changes are evident during this short period immediately after fixed appliance removal This is being investigated because portions of the teeth under the braces have been shielded from the oral cavity for several years and they may also have been desiccated during the removal of braces Additionally the gums may be puffy and swollen immediately after taking braces off and parts of the teeth may not be visible The photographs will be sent to the online data capture system
At the eight-week time point NW PRECEDENT providers will recall the subjects 240 total and take the eight-week follow-up photographs in the same standardized format as the baseline photographs The photographs will be sent via the online data capture system The NW PRECEDENT provider will administer an in office survey to the subject to gather information regarding satisfaction with using the treatment compliance oral hygiene practices and self-assessment of improvement of the WSL
A group of blinded examiners consisting of five to ten laypersons and five to ten dental experts will view each subjects set of digital photographs in chronological order on a PowerPoint presentation The photographs will only show the four maxillary incisor teeth and will be unidentifiable to the examiners Each set of photographs will then be given an improvement rating on a 100 mm visual analog scale VAS 0no improvement 100100 improvement In addition both a graduate orthodontic resident and a dental student will blindly assess the digital photographs by measuring the size of the white spot lesion relative to the rest of the tooth expressed as a percent Statistical analysis will then be performed
Casein phosphopeptide-amorphous calcium phosphate CPP-ACP containing products are a recently proposed therapy for the treatment of white spots following orthodontic treatment CPP is thought to stabilize and localize calcium fluoride and phosphate at the tooth surface in a slow-release amorphous form thus enhancing deeper remineralization of WSL Products containing CPP-ACP are currently marketed under various names including MI Paste Plus which also contains fluoride Few in vivo studies have investigated the effectiveness of various remineralization products to address WSL after orthodontics This project is a single-blind randomized clinical trial with three arms - MI Paste Plus for an 8-week duration a single application of Duraphat Fluoride Varnish with reassessment at 8 weeks and normal home care for an 8 week period Subjects will be recruited at their regularly scheduled orthodontic appointments with eligible subjects being up to 2 years post-removal of fixed orthodontic appliances
This project is intended to answer four questions regarding the management of white spot lesions
Specific Aim 1 to compare the effectiveness MI Paste Plus and Duraphat Fluoride Varnish to a standard oral hygienetoothpaste regimen in improving the appearance of WSL after orthodontic treatment
Specific Aim 2 to investigate subjects self-assessment of improvement in each of the three arms
Specific Aim 3 to investigate variables such as age gender time since fixed orthodontic appliance removal compliance oral hygiene practices etc that may influence WSL improvement
Specific Aim 4 to investigate the short-term changes in WSL from the day of orthodontic appliance removal until the day of retainer delivery usually 2 - 7 days
This study will provide valuable evidence on the management of WSL after orthodontic treatment As previously stated WSL lesions are quite common and difficult to reverse so it is important to conduct rigorous clinical research in an effort to develop effective strategies
This study will be a randomized clinical trial NW PRECEDENT providers will invite subjects to participate if they are between the ages of 12 and 20 and have at least one new WSL on the 4 maxillary incisors associated with orthodontic treatment These are the most common teeth to develop these lesions The NW PRECEDENT provider must verify that the WSL were not present in the pre-orthodontic treatment records Subjects must be willing to be placed into any of the following three groups
1 Test Group A 10 CPP-ACP 900 ppm Fluoride paste - a trained staff member from the NW PRECEDENT dentalorthodontic office will give 3 tubes of MI Paste Plus and instructions to the subject for home use The subjects will also receive non-prescription fluoride toothpaste 1100 ppm Fluoride and oral hygiene instructions The group will consist of 80 subjects and each subject will be given enough MI Paste for the duration of the trial Treatment will begin on the day of retainer delivery if the subject was recruited on the day of fixed appliance removal Otherwise the treatment will begin on the date of recruitment
2 Test Group B Fluoride Varnish Group - a trained staff member from the NW PRECEDENT dentalorthodontic office will provide a single fluoride varnish application 22600 ppm Fluoride to the subject The subjects will also receive non-prescription fluoride toothpaste 1100 ppm Fluoride and oral hygiene instructions The group will consist of 80 subjects Treatment will begin on the day of retainer delivery if the subject was recruited on the day of fixed appliance removal Otherwise the treatment will begin on the date of recruitment
3 Control Group - These 80 subjects will receive non-prescription fluoride toothpaste 1100 ppm Fluoride and oral hygiene instructions at the time of enrollment After the trial is completed August 2011 these subjects will be informed of the results and offered one of the two active arms if they are found to be effective in reducing WSL
The NW PRECEDENT provider and the subject will also fill out a short survey to compile information about the subjects age gender race ethnicity time in fixed appliances oral hygiene during treatment and type of retainers after orthodontic treatment Upon determining a subjects eligibility and willingness to participate as well as obtaining assentconsent heshe will be randomly assigned to a group a baseline photograph will be taken and the assigned treatment will begin In the case of subjects who have just had their orthodontic appliances removed the subjects will undergo enrollment and photos but their assigned treatment will not begin until the day of retainer delivery The subjects general dentist if they did not perform their orthodontic care will be sent a letter informing them that their patients are currently enrolled in the study and that any additional treatment for white spot lesions should be delayed until the study is complete 8 weeks
Subjects who are identified at some time after their fixed orthodontic appliances have been removed will have baseline photographs taken on the day of recruitment Subjects who are identified on the day their appliances are removed will have photographs taken on that day as well at the time of retainer delivery 2 - 7 days later A subsequent analysis of the day of fixed appliance removal and one week follow-up photographs will be performed in order to determine if significant changes are evident during this short period immediately after fixed appliance removal This is being investigated because portions of the teeth under the braces have been shielded from the oral cavity for several years and they may also have been desiccated during the removal of braces Additionally the gums may be puffy and swollen immediately after taking braces off and parts of the teeth may not be visible The photographs will be sent to the online data capture system
At the eight-week time point NW PRECEDENT providers will recall the subjects 240 total and take the eight-week follow-up photographs in the same standardized format as the baseline photographs The photographs will be sent via the online data capture system The NW PRECEDENT provider will administer an in office survey to the subject to gather information regarding satisfaction with using the treatment compliance oral hygiene practices and self-assessment of improvement of the WSL
A group of blinded examiners consisting of five to ten laypersons and five to ten dental experts will view each subjects set of digital photographs in chronological order on a PowerPoint presentation The photographs will only show the four maxillary incisor teeth and will be unidentifiable to the examiners Each set of photographs will then be given an improvement rating on a 100 mm visual analog scale VAS 0no improvement 100100 improvement In addition both a graduate orthodontic resident and a dental student will blindly assess the digital photographs by measuring the size of the white spot lesion relative to the rest of the tooth expressed as a percent Statistical analysis will then be performed
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