The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
Primary Purpose
Orthodontic Appliance Complication
Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Fluoridated toothpaste
fluoride varnish (5% sodium fluoride)
CPP-ACP plus crème group
Sponsored by
About this trial
This is an interventional treatment trial for Orthodontic Appliance Complication focused on measuring White Spot Lesion, Bacterial count( Streptococcus & Lactobacillus count), Salivary profile(salivary flow rate, buffering capacity, pH)
Eligibility Criteria
Inclusion Criteria:
- Subjects on multibracket fixed appliance treatment
- Subjects with 2 or more bracketed surfaces with labial subsurface WSLs from
- upper right permanent canine (13) to upper left permanent canine (23) with an ICDAS II score of 1 and 2 will be selected.
- Indicated for thermoform or vacuum formed retainers on the upper arch.
Exclusion Criteria:
- Systemic diseases or any physical anomalies.
- Subjects with intention to move out from Klang Valley area for the next 1.5 years.
- Periodontal diseases (pocket depth of more than 3mm).
- Smoker.
- Severe fluorosis or any enamel abnormalities.
- Antimicrobial agents or antibiotic therapy within the past 3 months.
- Orthognathic surgery cases, cleft lip and palate.
- Single arched lower fixed orthodontic treatment.
- Milk protein and benzoate preservatives (a common preservatives) allergies.
Sites / Locations
- Postgraduate Orthodontic Clinic, Faculty Of Dentistry, University Of MalayaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Toothpaste group
Fluoride Varnish group
CPP-ACP plus crème group
Arm Description
Control group using fluoridated toothpaste
Fluoride varnish (5% sodium fluoride) application on 3 months interval
CPP-ACP plus crème application 2 times daily
Outcomes
Primary Outcome Measures
ICDAS score of the white spot lesion.
Changes in WSL measured based on ICDAS score :
0 No evidence of caries
1 Initial caries
2 Distinct visual change in enamel
3 Localised enamel breakdown due to caries with no visible dentine
4 Underlying dark shadow from dentine
5 Distinct cavity with visible dentine
6 Extensive distinct cavity with visible dentine
Optical changes (refractive index) of the white spot lesion.
Changes in WSL measured in lesion depths (LD in μm).
Patient perception of the WSL
Patient will be given a set of questionnaires at every follow up visit to assess the
Compliance to the remineralizing agent application
Perception on the WSL
The perception will be based on the Likert scale
Dental plaque total bacterial count, Streptococcus count, Lactobacillus count.
Plaque samples will be collected with sterile swabs from the enamel surface of each tooth with the identified WSL to measure the bacterial count.
The colony forming units of each plates is enumerated and the cfu/mL will be calculated
Secondary Outcome Measures
Salivary profile (salivary flow rate)
The stimulated saliva will be collected by having the subject spit for 10 minutes into a sterile plastic graduated cup with 1-mL gradation marks Collected salivary volume was measured in millilitres, and salivary flow rate was calculated based on a collection time of 10 minutes (millilitres per minute).
Salivary profile (buffering capacity)
The saliva buffer capacity will be measured using strips (Saliva-Check BUFFER) and measured against standards assigned by the manufacturer Using a pipette, a saliva sample will be taken, and 1 drop will be placed on each of the 3 test pads. Test pads will change colour immediately, but the final colour will only detect after 2 minutes.
Then the result will be calculated by adding the points according to the final colour of each pad.
green - 4 points
green/ blue - 3 points
blue - 2 points
red/blue - 1 point
red - 0 points
All points were counted, and result was determined:
0 - 5 points as very low buffering ability,
6 - 9 points as low,
10 - 12 points as normal/high.
The buffering capacity is based on total points , 0-5 ( very low) , 6-9 (low), 10-12 (normal)
Salivary profile (pH)
The pH test strip will be placed inside the saliva collection cup for 10 seconds.
The colour of the strip will be compared to the testing chart available in the kit .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04788550
Brief Title
The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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:
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
To compare the bacterial count (including streptococcus and lactobacillus) in subjects with white spot lesions treated with different remineralizing agents during orthodontic retention
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 0.49 (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 0.5-1.0ml 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),
Debond procedure will be done according to the standard protocol.
Two sets of impression will be taken for the construction of study model, construction of the standard retainers and also for the research purpose.
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.
The salivary profile (flow rate, Ph, buffering capacity) will be measured using Saliva- Check BUFFER (GC America) according to the manufacturer's instruction.
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,
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.
ICDAS score and optical changes (lesion depth and integrated refractivity) of the white spot lesion will be measured.
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
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)
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
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 < 0.05 is considered statistically significant. The data collected will be analyzed using an intention-to-treat basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Appliance Complication
Keywords
White Spot Lesion, Bacterial count( Streptococcus & Lactobacillus count), Salivary profile(salivary flow rate, buffering capacity, pH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1 The participants in group one will act as control group as they will be advised in using fluoridated toothpaste to brush twice daily during the follow up periods
Group 2 The participants in this group will received fluoride varnish (5% sodium fluoride) treatment
Group 3 The participants will be advised to use pea size CPP-ACP plus crème (900ppm fluoride)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toothpaste group
Arm Type
Active Comparator
Arm Description
Control group using fluoridated toothpaste
Arm Title
Fluoride Varnish group
Arm Type
Experimental
Arm Description
Fluoride varnish (5% sodium fluoride) application on 3 months interval
Arm Title
CPP-ACP plus crème group
Arm Type
Experimental
Arm Description
CPP-ACP plus crème application 2 times daily
Intervention Type
Combination Product
Intervention Name(s)
Fluoridated toothpaste
Other Intervention Name(s)
Colgate® Maximum cavity protection great regular flavour
Intervention Description
Group 1 will act as control group. Participants will be advised to brush twice daily using fluoridated toothpaste during the follow up periods. No other fluorides supplements will be allowed to use.
Intervention Type
Combination Product
Intervention Name(s)
fluoride varnish (5% sodium fluoride)
Other Intervention Name(s)
Colgate Duraphat 22,600 ppmF, 22,600 ppm Sodium Fluoride varnish
Intervention Description
Approximately 0.5-1.0ml fluoride varnish will be applied on the tooth surface (labially) with the paint-on method fom canines to canines. No other fluorides supplements will be allowed to use.
Intervention Type
Combination Product
Intervention Name(s)
CPP-ACP plus crème group
Other Intervention Name(s)
GC Tooth Mousse Plus®
Intervention Description
Pea size CPP-ACP plus crème on the tooth surfaces using a clean fingers twice daily after brushing their teeth with fluoridated toothpaste. No other fluorides supplements will be allowed to use.
Primary Outcome Measure Information:
Title
ICDAS score of the white spot lesion.
Description
Changes in WSL measured based on ICDAS score :
0 No evidence of caries
1 Initial caries
2 Distinct visual change in enamel
3 Localised enamel breakdown due to caries with no visible dentine
4 Underlying dark shadow from dentine
5 Distinct cavity with visible dentine
6 Extensive distinct cavity with visible dentine
Time Frame
18 months
Title
Optical changes (refractive index) of the white spot lesion.
Description
Changes in WSL measured in lesion depths (LD in μm).
Time Frame
18 months
Title
Patient perception of the WSL
Description
Patient will be given a set of questionnaires at every follow up visit to assess the
Compliance to the remineralizing agent application
Perception on the WSL
The perception will be based on the Likert scale
Time Frame
18 months
Title
Dental plaque total bacterial count, Streptococcus count, Lactobacillus count.
Description
Plaque samples will be collected with sterile swabs from the enamel surface of each tooth with the identified WSL to measure the bacterial count.
The colony forming units of each plates is enumerated and the cfu/mL will be calculated
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Salivary profile (salivary flow rate)
Description
The stimulated saliva will be collected by having the subject spit for 10 minutes into a sterile plastic graduated cup with 1-mL gradation marks Collected salivary volume was measured in millilitres, and salivary flow rate was calculated based on a collection time of 10 minutes (millilitres per minute).
Time Frame
18 months
Title
Salivary profile (buffering capacity)
Description
The saliva buffer capacity will be measured using strips (Saliva-Check BUFFER) and measured against standards assigned by the manufacturer Using a pipette, a saliva sample will be taken, and 1 drop will be placed on each of the 3 test pads. Test pads will change colour immediately, but the final colour will only detect after 2 minutes.
Then the result will be calculated by adding the points according to the final colour of each pad.
green - 4 points
green/ blue - 3 points
blue - 2 points
red/blue - 1 point
red - 0 points
All points were counted, and result was determined:
0 - 5 points as very low buffering ability,
6 - 9 points as low,
10 - 12 points as normal/high.
The buffering capacity is based on total points , 0-5 ( very low) , 6-9 (low), 10-12 (normal)
Time Frame
18 months
Title
Salivary profile (pH)
Description
The pH test strip will be placed inside the saliva collection cup for 10 seconds.
The colour of the strip will be compared to the testing chart available in the kit .
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects on multibracket fixed appliance treatment
Subjects with 2 or more bracketed surfaces with labial subsurface WSLs from
upper right permanent canine (13) to upper left permanent canine (23) with an ICDAS II score of 1 and 2 will be selected.
Indicated for thermoform or vacuum formed retainers on the upper arch.
Exclusion Criteria:
Systemic diseases or any physical anomalies.
Subjects with intention to move out from Klang Valley area for the next 1.5 years.
Periodontal diseases (pocket depth of more than 3mm).
Smoker.
Severe fluorosis or any enamel abnormalities.
Antimicrobial agents or antibiotic therapy within the past 3 months.
Orthognathic surgery cases, cleft lip and palate.
Single arched lower fixed orthodontic treatment.
Milk protein and benzoate preservatives (a common preservatives) allergies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Najwa Zakaria
Phone
0176476058
Email
najwazakaria87@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wan Nurazreena Wan Hassan
Phone
0379674802
Email
wannurazreena@um.edu.my
Facility Information:
Facility Name
Postgraduate Orthodontic Clinic, Faculty Of Dentistry, University Of Malaya
City
Kuala Lumpur
State/Province
WP Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najwa Zakaria
Phone
0176476058
Email
najwazakaria87@yahoo.com
First Name & Middle Initial & Last Name & Degree
Wan Nurazreena Wan Hassan
Phone
0379674802
Email
wannurazreena@um.edu.my
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
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