Study of Treatments Used for White Spot Lesions After Orthodontic Treatment.
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 12 - 20 |
| Updated: | 4/21/2016 |
| Start Date: | March 2010 |
| End Date: | July 2012 |
Treatment of White Spot Lesions After Orthodontic Treatment: A Practice-based Randomized Controlled Trial
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 dentists/orthodontists 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.
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 dentists/orthodontists 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.
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 hygiene/toothpaste 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 dental/orthodontic 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
dental/orthodontic office will provide a single fluoride varnish application (22,600
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 subject's age, gender, race, ethnicity, time in fixed appliances, oral
hygiene during treatment, and type of retainers after orthodontic treatment. Upon
determining a subject's eligibility and willingness to participate, as well as obtaining
assent/consent, he/she 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 subject's
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 subject's 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) (0=no improvement, 100=100%
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.
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 hygiene/toothpaste 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 dental/orthodontic 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
dental/orthodontic office will provide a single fluoride varnish application (22,600
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 subject's age, gender, race, ethnicity, time in fixed appliances, oral
hygiene during treatment, and type of retainers after orthodontic treatment. Upon
determining a subject's eligibility and willingness to participate, as well as obtaining
assent/consent, he/she 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 subject's
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 subject's 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) (0=no improvement, 100=100%
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.
Inclusion Criteria:
- Completed fixed appliance orthodontic therapy within the past two years
- Have at least one white spot lesion on the facial surface of a maxillary central or
lateral incisor tooth that was not present prior to treatment with fixed orthodontic
appliances.
- Between the ages of 12 and 20 years of age
- Agrees to randomization to the different treatment protocols
- Signed informed consent obtained from a parent or guardian of the patient f the
patient is under the age of eighteen
Exclusion Criteria:
- Not willing to be randomly assigned to one of the three treatment groups
- Any abnormal oral, medical, or mental conditions, including any milk-related
allergies and/or any medical conditions involving the kidneys.
- Any patients who underwent therapy for white spot lesion after completion of
orthodontic treatment
- Any white spot lesion present on qualifying teeth with frank cavitation
- Patient is non-English speaking or non-English reading
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