Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788550
Status:
UNKNOWN
Last Update Posted:
2021-10-22
First Post:
2021-03-01
Brief Title:
The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
A Prospective Open Label Randomized Control Trial to Study the Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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:
Dental caries is a decay process that breaks down the tooth The earliest clinical signs of active dental caries is seen as white spot lesions WSLs WSLs causes porosity below the tooth surface as a result of demineralization that gives the lesion a milky white appearance
Many WSLs persevere even a decade after orthodontic appliance removal and remain a cosmetic problem After removal of fixed appliances a considerable improvement of WSLs can be seen during the first 6-24 months but the degree of improvement varies between individuals
Two common bacteria in dental plaque causes caries Streptococcus mutans SM and Lactobacillus acidophilus LA in the plaque contributes to the initiation and progression of caries respectively
A major strategy suggested to deal with existing WSL after debond is to facilitate remineralisation using remineralising agents that contain fluoride This can be from daily use of fluoridated toothpastes or having additional dose of fluoride application Certain agents also contain casein phosphopeptide-stabilize amorphous calcium phosphate CPP-ACP that is believed to have an antibacterial and buffering effect on plaque and interfere the growth and adherence of bacteria
Many WSLs persevere even a decade after orthodontic appliance removal and remain a cosmetic problem After removal of fixed appliances a considerable improvement of WSLs can be seen during the first 6-24 months but the degree of improvement varies between individuals
Two common bacteria in dental plaque causes caries Streptococcus mutans SM and Lactobacillus acidophilus LA in the plaque contributes to the initiation and progression of caries respectively
A major strategy suggested to deal with existing WSL after debond is to facilitate remineralisation using remineralising agents that contain fluoride This can be from daily use of fluoridated toothpastes or having additional dose of fluoride application Certain agents also contain casein phosphopeptide-stabilize amorphous calcium phosphate CPP-ACP that is believed to have an antibacterial and buffering effect on plaque and interfere the growth and adherence of bacteria
Detailed Description:
Rationale of the study
Currently there is insufficient evidence on the most effective regime of fluoride application to regress post orthodontic WSLs and how it affects the quality and quantity of oral microbial flora
The study aims to determine the effect of different remineralizing agents on white spot lesions and dental plaque of post-orthodontic treatment patients
The objectives are
1 To compare the tooth surface changes based on ICDAS optical changes and patient perception of white spot lesion treated with different remineralizing agents during orthodontic retention
2 To compare the bacterial count including streptococcus and lactobacillus in subjects with white spot lesions treated with different remineralizing agents during orthodontic retention
3 To compare the salivary profile flow rate Ph buffering capacity in subjects with white spot lesion treated with different remineralizing agents during orthodontic retention
Sample size calculation
Sample size was calculated using G-power Given an effect size of 049 Jung et al 2014 80 power of study alpha of 5 and 7 measurements the sample size required was 27 With a 10 dropout the final sample size is 30
Methodology
A Subjects screening and preparation
Orthodontic patients treated with at least fixed appliances on the maxillary arch at the Faculty of Dentistry University of Malaya whom are scheduled for debond are invited to participate in this study Participants will be screened for white spot lesions based on the inclusion and exclusion criteria Participants will be randomly allocated to 3 groups that will receive remineralizing applications according to their allocated groups
Group 1 The participants in group 1 will act as control group as they will be advised in using fluoridated toothpaste to brush twice daily during the follow up periods No other fluorides supplements will be allowed to use
Group 2 The participants in this group will received fluoride varnish 5 sodium fluoride treatment The labial surface of each tooth will be polished with non-fluoridated pumice powder and will be rinsed and dried thoroughly Approximately 05-10ml fluoride varnish will be applied on the tooth surface labially with the paint-on method from canines to canines After varnish application patients will be advised not to drink for at least 30 minutes and not to brush teeth or eat food for the next 4 hours after application Participants can brush teeth the night after application The participants will be advised to brush their teeth daily with fluoridated toothpaste Fluoride varnish application will be on 3 months intervals from first review visit T1 No other fluorides supplements will be allowed to use
Group 3 The participants will be advised to use pea size CPP-ACP plus crème on the tooth surfaces using a clean fingers twice daily following brushing their teeth with fluoridated toothpaste The participants will be taught to keep the CPP-ACP plus crème on the tooth surface for at least 3 minutes before rinsing the mouth After application of CPP-ACP plus crème participants will be advised not to drink or eat for at least 30 minutes No other fluoride supplements will be allowed to use
During the first appointment T0
1 Debond procedure will be done according to the standard protocol
2 Two sets of impression will be taken for the construction of study model construction of the standard retainers and also for the research purpose
3 Participants will be screen for white spot lesion by using the Optical Coherence Tomography Santec A jig will be constructed for reproducible positioning of the probe Two maxillary teeth with the worst WSL will be selected for each patient to measure the lesion depth and integrated refractivity The intraoral photos of the maxillary teeth will be taken
4 The salivary profile flow rate Ph buffering capacity will be measured using Saliva- Check BUFFER GC America according to the manufacturers instruction
5 Plaque samples will be collected with sterile swabs from the enamel surface of each tooth with the identified WSL to measure the bacterial count
1 day after T0
1 Participants will receive pressure formed or thermoplastic retainer in upper arch and instructed to wear their retainers all day for at least 8 hours and wear them after toothbrushing
2 ICDAS score and optical changes lesion depth and integrated refractivity of the white spot lesion will be measured
3 Participants will be given a set of questionnaires to assess the compliance to the remineralizing agent application and perception on the WSL
Treatment follow up
1 The participants will be coordinated for follow up after 3 months T1 6 months T2 9 months T3 12 months T4 and 18 months T5
2 During the follow up visit each participant will be subjected to the measurement of
tooth surface changes
bacterial count
salivary profile
intraoral photos of maxillary teeth
3 Participants will be given a set of questionnaires at every follow up visit to assess the compliance to the application of remineralizing agent and perception of the WSLs
Statistical Analysis
Data analysis will be done using the SPSS version 22 Descriptive date will be expressed as mean standard deviation SD unless otherwise stated Repeated measurement ANOVA will be used for analysis of normally distributed variables Kruskal-Wallis ANOVA will be used for non-normally distributed data A value of P 005 is considered statistically significant The data collected will be analyzed using an intention-to-treat basis
Currently there is insufficient evidence on the most effective regime of fluoride application to regress post orthodontic WSLs and how it affects the quality and quantity of oral microbial flora
The study aims to determine the effect of different remineralizing agents on white spot lesions and dental plaque of post-orthodontic treatment patients
The objectives are
1 To compare the tooth surface changes based on ICDAS optical changes and patient perception of white spot lesion treated with different remineralizing agents during orthodontic retention
2 To compare the bacterial count including streptococcus and lactobacillus in subjects with white spot lesions treated with different remineralizing agents during orthodontic retention
3 To compare the salivary profile flow rate Ph buffering capacity in subjects with white spot lesion treated with different remineralizing agents during orthodontic retention
Sample size calculation
Sample size was calculated using G-power Given an effect size of 049 Jung et al 2014 80 power of study alpha of 5 and 7 measurements the sample size required was 27 With a 10 dropout the final sample size is 30
Methodology
A Subjects screening and preparation
Orthodontic patients treated with at least fixed appliances on the maxillary arch at the Faculty of Dentistry University of Malaya whom are scheduled for debond are invited to participate in this study Participants will be screened for white spot lesions based on the inclusion and exclusion criteria Participants will be randomly allocated to 3 groups that will receive remineralizing applications according to their allocated groups
Group 1 The participants in group 1 will act as control group as they will be advised in using fluoridated toothpaste to brush twice daily during the follow up periods No other fluorides supplements will be allowed to use
Group 2 The participants in this group will received fluoride varnish 5 sodium fluoride treatment The labial surface of each tooth will be polished with non-fluoridated pumice powder and will be rinsed and dried thoroughly Approximately 05-10ml fluoride varnish will be applied on the tooth surface labially with the paint-on method from canines to canines After varnish application patients will be advised not to drink for at least 30 minutes and not to brush teeth or eat food for the next 4 hours after application Participants can brush teeth the night after application The participants will be advised to brush their teeth daily with fluoridated toothpaste Fluoride varnish application will be on 3 months intervals from first review visit T1 No other fluorides supplements will be allowed to use
Group 3 The participants will be advised to use pea size CPP-ACP plus crème on the tooth surfaces using a clean fingers twice daily following brushing their teeth with fluoridated toothpaste The participants will be taught to keep the CPP-ACP plus crème on the tooth surface for at least 3 minutes before rinsing the mouth After application of CPP-ACP plus crème participants will be advised not to drink or eat for at least 30 minutes No other fluoride supplements will be allowed to use
During the first appointment T0
1 Debond procedure will be done according to the standard protocol
2 Two sets of impression will be taken for the construction of study model construction of the standard retainers and also for the research purpose
3 Participants will be screen for white spot lesion by using the Optical Coherence Tomography Santec A jig will be constructed for reproducible positioning of the probe Two maxillary teeth with the worst WSL will be selected for each patient to measure the lesion depth and integrated refractivity The intraoral photos of the maxillary teeth will be taken
4 The salivary profile flow rate Ph buffering capacity will be measured using Saliva- Check BUFFER GC America according to the manufacturers instruction
5 Plaque samples will be collected with sterile swabs from the enamel surface of each tooth with the identified WSL to measure the bacterial count
1 day after T0
1 Participants will receive pressure formed or thermoplastic retainer in upper arch and instructed to wear their retainers all day for at least 8 hours and wear them after toothbrushing
2 ICDAS score and optical changes lesion depth and integrated refractivity of the white spot lesion will be measured
3 Participants will be given a set of questionnaires to assess the compliance to the remineralizing agent application and perception on the WSL
Treatment follow up
1 The participants will be coordinated for follow up after 3 months T1 6 months T2 9 months T3 12 months T4 and 18 months T5
2 During the follow up visit each participant will be subjected to the measurement of
tooth surface changes
bacterial count
salivary profile
intraoral photos of maxillary teeth
3 Participants will be given a set of questionnaires at every follow up visit to assess the compliance to the application of remineralizing agent and perception of the WSLs
Statistical Analysis
Data analysis will be done using the SPSS version 22 Descriptive date will be expressed as mean standard deviation SD unless otherwise stated Repeated measurement ANOVA will be used for analysis of normally distributed variables Kruskal-Wallis ANOVA will be used for non-normally distributed data A value of P 005 is considered statistically significant The data collected will be analyzed using an intention-to-treat basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None