Orthodontic Appliance ComplicationNCT04788550
The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
A study testing Fluoridated toothpaste, fluoride varnish (5% sodium fluoride) and CPP-ACP plus crème group in people with Orthodontic Appliance Complication, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Fluoridated toothpaste, fluoride varnish (5% sodium fluoride) and CPP-ACP plus crème group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Orthognathic surgery cases, cleft lip and palate.
- Single arched lower fixed orthodontic treatment.
- Milk protein and benzoate preservatives (a common preservatives) allergies.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Postgraduate Orthodontic Clinic, Faculty Of Dentistry, University Of Malaya
Kuala Lumpur, WP Kuala Lumpur, 50603
Najwa Zakaria, 0176476058, najwazakaria87@yahoo.com
Wan Nurazreena Wan Hassan, 0379674802, wannurazreena@um.edu.my
About this study
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
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.
Read more
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.
Read the 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 :
- 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.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Fluoridated toothpaste, fluoride varnish (5% sodium fluoride), CPP-ACP plus crème group
- Keywords
- White Spot Lesion, Bacterial count( Streptococcus & Lactobacillus count), Salivary profile(salivary flow rate, buffering capacity, pH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoridated toothpasteCombination product
Also called Colgate® Maximum cavity protection great regular flavour
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.
fluoride varnish (5% sodium fluoride)Combination product
Also called Colgate Duraphat 22,600 ppmF, 22,600 ppm Sodium Fluoride varnish
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.
CPP-ACP plus crème groupCombination product
Also called GC Tooth Mousse Plus®
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.
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste group | Active comparator | Control group using fluoridated toothpaste Receives: Combination Product: Fluoridated toothpaste |
| Fluoride Varnish group | Experimental | Fluoride varnish (5% sodium fluoride) application on 3 months interval Receives: Combination Product: fluoride varnish (5% sodium fluoride) |
| CPP-ACP plus crème group | Experimental | CPP-ACP plus crème application 2 times daily Receives: Combination Product: CPP-ACP plus crème group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Optical changes (refractive index) of the white spot lesion.
Changes in WSL measured in lesion depths (LD in μm).
Measured: 18 months
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
Measured: 18 months
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
Measured: 18 months
Secondary outcomes (3)
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).
Measured: 18 months
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)
Measured: 18 months
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 .
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start17 Mar 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Wan Nurazreena Wan Hassan, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788550
- Sponsor's protocol ID
- DGD_190005
- Status last verified
- Oct 2021
- First submitted
- 1 Mar 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pitts NB, Zero DT, Marsh PD, Ekstrand K, Weintraub JA, Ramos-Gomez F, Tagami J, Twetman S, Tsakos G, Ismail A. Dental caries. Nat Rev Dis Primers. 2017 May 25;3:17030. doi: 10.1038/nrdp.2017.30.
PubMed 28540937Simon-Soro A, Mira A. Solving the etiology of dental caries. Trends Microbiol. 2015 Feb;23(2):76-82. doi: 10.1016/j.tim.2014.10.010. Epub 2014 Nov 27.
PubMed 25435135van Houte J. Role of micro-organisms in caries etiology. J Dent Res. 1994 Mar;73(3):672-81. doi: 10.1177/00220345940730031301.
PubMed 8163737Mizrahi E. Enamel demineralization following orthodontic treatment. Am J Orthod. 1982 Jul;82(1):62-7. doi: 10.1016/0002-9416(82)90548-6.
PubMed 6984291Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.
PubMed 6758594Ogaard B, Rolla G, Arends J, ten Cate JM. Orthodontic appliances and enamel demineralization. Part 2. Prevention and treatment of lesions. Am J Orthod Dentofacial Orthop. 1988 Aug;94(2):123-8. doi: 10.1016/0889-5406(88)90360-5.
PubMed 3165239Mitchell L. Decalcification during orthodontic treatment with fixed appliances--an overview. Br J Orthod. 1992 Aug;19(3):199-205. doi: 10.1179/bjo.19.3.199. No abstract available.
PubMed 1390575Artun J, Brobakken BO. Prevalence of carious white spots after orthodontic treatment with multibonded appliances. Eur J Orthod. 1986 Nov;8(4):229-34. doi: 10.1093/ejo/8.4.229. No abstract available.
PubMed 3466795Gwinnett AJ, Ceen RF. Plaque distribution on bonded brackets: a scanning microscope study. Am J Orthod. 1979 Jun;75(6):667-77. doi: 10.1016/0002-9416(79)90098-8. No abstract available.
PubMed 377979Chapman JA, Roberts WE, Eckert GJ, Kula KS, Gonzalez-Cabezas C. Risk factors for incidence and severity of white spot lesions during treatment with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):188-94. doi: 10.1016/j.ajodo.2008.10.019.
PubMed 20691360Featherstone JD. The science and practice of caries prevention. J Am Dent Assoc. 2000 Jul;131(7):887-99. doi: 10.14219/jada.archive.2000.0307.
PubMed 10916327Chatterjee R, Kleinberg I. Effect of orthodontic band placement on the chemical composition of human incisor tooth plaque. Arch Oral Biol. 1979;24(2):97-100. doi: 10.1016/0003-9969(79)90056-6. No abstract available.
PubMed 45361Scheie AA, Arneberg P, Krogstad O. Effect of orthodontic treatment on prevalence of Streptococcus mutans in plaque and saliva. Scand J Dent Res. 1984 Jun;92(3):211-7. doi: 10.1111/j.1600-0722.1984.tb00881.x.
PubMed 6589736Freitas AO, Marquezan M, Nojima Mda C, Alviano DS, Maia LC. The influence of orthodontic fixed appliances on the oral microbiota: a systematic review. Dental Press J Orthod. 2014 Mar-Apr;19(2):46-55. doi: 10.1590/2176-9451.19.2.046-055.oar.
PubMed 24945514Nyvad B. Microbial colonization of human tooth surfaces. APMIS Suppl. 1993;32:1-45. No abstract available.
PubMed 8494649
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04788550
- Acronym / sponsor ID
- DGD_190005
- Conditions
- Orthodontic Appliance Complication
- Keywords
- White Spot Lesion, Bacterial count( Streptococcus & Lactobacillus count), Salivary profile(salivary flow rate, buffering capacity, pH)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Toothpaste group | Active comparator | Combination Product: Fluoridated toothpasteControl group using fluoridated toothpaste |
| Fluoride Varnish group | Experimental | Combination Product: fluoride varnish (5% sodium fluoride)Fluoride varnish (5% sodium fluoride) application on 3 months interval |
| CPP-ACP plus crème group | Experimental | Combination Product: CPP-ACP plus crème groupCPP-ACP plus crème application 2 times daily |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoridated toothpasteAlso: Colgate® Maximum cavity protection great regular flavourGroup 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. | Combination product | Toothpaste group |
| fluoride varnish (5% sodium fluoride)Also: Colgate Duraphat 22,600 ppmF, 22,600 ppm Sodium Fluoride varnishApproximately 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. | Combination product | Fluoride Varnish group |
| CPP-ACP plus crème groupAlso: GC Tooth Mousse Plus®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. | Combination product | CPP-ACP plus crème group |
Primary outcome
ICDAS score of the white spot lesion.
Time frame: 18 months
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.
Time frame: 18 months
Changes in WSL measured in lesion depths (LD in μm).
Patient perception of the WSL
Time frame: 18 months
Patient will be given a set of questionnaires at every follow up visit to assess the 1. Compliance to the remineralizing agent application 2. Perception on the WSL The perception will be based on the Likert scale
Dental plaque total bacterial count, Streptococcus count, Lactobacillus count.
Time frame: 18 months
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
3 secondary outcomes
Salivary profile (salivary flow rate)
Time frame: 18 months
Salivary profile (buffering capacity)
Time frame: 18 months
Salivary profile (pH)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Background: PubMed 28540937Pitts NB, Zero DT, Marsh PD, Ekstrand K, Weintraub JA, Ramos-Gomez F, Tagami J, Twetman S, Tsakos G, Ismail A. Dental caries. Nat Rev Dis Primers. 2017 May 25;3:17030. doi: 10.1038/nrdp.2017.30.
- Background: PubMed 25435135Simon-Soro A, Mira A. Solving the etiology of dental caries. Trends Microbiol. 2015 Feb;23(2):76-82. doi: 10.1016/j.tim.2014.10.010. Epub 2014 Nov 27.
- Background: PubMed 8163737van Houte J. Role of micro-organisms in caries etiology. J Dent Res. 1994 Mar;73(3):672-81. doi: 10.1177/00220345940730031301.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoridated toothpaste, fluoride varnish (5% sodium fluoride) and CPP-ACP plus crème group in people with Orthodontic Appliance Complication, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Najwa Zakaria (0176476058, najwazakaria87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICDAS score of the white spot lesion. (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788550, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.