Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-28 @ 9:25 PM
Study NCT ID:
NCT04788550
Status:
UNKNOWN
Last Update Posted:
2021-10-22
First Post:
2021-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012969', 'term': 'Sodium Fluoride'}, {'id': 'C447032', 'term': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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\n\nGroup 2 The participants in this group will received fluoride varnish (5% sodium fluoride) treatment\n\nGroup 3 The participants will be advised to use pea size CPP-ACP plus crème (900ppm fluoride)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICDAS score of the white spot lesion.', 'timeFrame': '18 months', 'description': 'Changes in WSL measured based on ICDAS score :\n\n* 0 No evidence of caries\n* 1 Initial caries\n* 2 Distinct visual change in enamel\n* 3 Localised enamel breakdown due to caries with no visible dentine\n* 4 Underlying dark shadow from dentine\n* 5 Distinct cavity with visible dentine\n* 6 Extensive distinct cavity with visible dentine'}, {'measure': 'Optical changes (refractive index) of the white spot lesion.', 'timeFrame': '18 months', 'description': 'Changes in WSL measured in lesion depths (LD in μm).'}, {'measure': 'Patient perception of the WSL', 'timeFrame': '18 months', 'description': 'Patient will be given a set of questionnaires at every follow up visit to assess the\n\n1. Compliance to the remineralizing agent application\n2. Perception on the WSL\n\nThe perception will be based on the Likert scale'}, {'measure': 'Dental plaque total bacterial count, Streptococcus count, Lactobacillus count.', 'timeFrame': '18 months', '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.\n\nThe colony forming units of each plates is enumerated and the cfu/mL will be calculated'}], 'secondaryOutcomes': [{'measure': 'Salivary profile (salivary flow rate)', 'timeFrame': '18 months', '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).'}, {'measure': 'Salivary profile (buffering capacity)', 'timeFrame': '18 months', '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.\n\nThen the result will be calculated by adding the points according to the final colour of each pad.\n\n* green - 4 points\n* green/ blue - 3 points\n* blue - 2 points\n* red/blue - 1 point\n* red - 0 points\n\nAll points were counted, and result was determined:\n\n* 0 - 5 points as very low buffering ability,\n* 6 - 9 points as low,\n* 10 - 12 points as normal/high.\n\nThe buffering capacity is based on total points , 0-5 ( very low) , 6-9 (low), 10-12 (normal)'}, {'measure': 'Salivary profile (pH)', 'timeFrame': '18 months', 'description': 'The pH test strip will be placed inside the saliva collection cup for 10 seconds.\n\nThe colour of the strip will be compared to the testing chart available in the kit .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['White Spot Lesion', 'Bacterial count( Streptococcus & Lactobacillus count)', 'Salivary profile(salivary flow rate, buffering capacity, pH)'], 'conditions': ['Orthodontic Appliance Complication']}, 'referencesModule': {'references': [{'pmid': '28540937', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25435135', 'type': 'BACKGROUND', 'citation': 'Simon-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.'}, {'pmid': '8163737', 'type': 'BACKGROUND', 'citation': 'van Houte J. Role of micro-organisms in caries etiology. J Dent Res. 1994 Mar;73(3):672-81. doi: 10.1177/00220345940730031301.'}, {'pmid': '6984291', 'type': 'BACKGROUND', 'citation': 'Mizrahi E. Enamel demineralization following orthodontic treatment. Am J Orthod. 1982 Jul;82(1):62-7. doi: 10.1016/0002-9416(82)90548-6.'}, {'pmid': '6758594', 'type': 'BACKGROUND', 'citation': 'Gorelick 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.'}, {'pmid': '3165239', 'type': 'BACKGROUND', 'citation': 'Ogaard 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.'}, {'pmid': '1390575', 'type': 'BACKGROUND', 'citation': 'Mitchell 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.'}, {'pmid': '3466795', 'type': 'BACKGROUND', 'citation': 'Artun 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.'}, {'pmid': '377979', 'type': 'BACKGROUND', 'citation': 'Gwinnett 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.'}, {'pmid': '20691360', 'type': 'BACKGROUND', 'citation': 'Chapman 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.'}, {'pmid': '10916327', 'type': 'BACKGROUND', 'citation': 'Featherstone 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.'}, {'pmid': '45361', 'type': 'BACKGROUND', 'citation': 'Chatterjee 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.'}, {'pmid': '6589736', 'type': 'BACKGROUND', 'citation': 'Scheie 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.'}, {'pmid': '24945514', 'type': 'BACKGROUND', 'citation': 'Freitas 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.'}, {'pmid': '8494649', 'type': 'BACKGROUND', 'citation': 'Nyvad B. Microbial colonization of human tooth surfaces. APMIS Suppl. 1993;32:1-45. No abstract available.'}, {'pmid': '4998039', 'type': 'BACKGROUND', 'citation': 'Socransky SS, Manganiello SD. The oral microbiota of man from birth to senility. J Periodontol. 1971 Aug;42(8):485-96. doi: 10.1902/jop.1971.42.8.485. No abstract available.'}, {'pmid': '20383105', 'type': 'BACKGROUND', 'citation': 'Lara-Carrillo E, Montiel-Bastida NM, Sanchez-Perez L, Alanis-Tavira J. Effect of orthodontic treatment on saliva, plaque and the levels of Streptococcus mutans and Lactobacillus. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e924-9. doi: 10.4317/medoral.15.e924.'}, {'pmid': '17907481', 'type': 'BACKGROUND', 'citation': 'Schirrmeister JF, Gebrande JP, Altenburger MJ, Monting JS, Hellwig E. Effect of dentifrice containing 5000 ppm fluoride on non-cavitated fissure carious lesions in vivo after 2 weeks. Am J Dent. 2007 Aug;20(4):212-6.'}, {'pmid': '11138645', 'type': 'BACKGROUND', 'citation': 'Alexander SA, Ripa LW. Effects of self-applied topical fluoride preparations in orthodontic patients. Angle Orthod. 2000 Dec;70(6):424-30. doi: 10.1043/0003-3219(2000)0702.0.CO;2.'}, {'pmid': '20691346', 'type': 'BACKGROUND', 'citation': 'Shungin D, Olsson AI, Persson M. Orthodontic treatment-related white spot lesions: a 14-year prospective quantitative follow-up, including bonding material assessment. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):136.e1-8; discussion 136-7. doi: 10.1016/j.ajodo.2009.05.020.'}, {'pmid': '2069145', 'type': 'BACKGROUND', 'citation': 'Rosenbloom RG, Tinanoff N. Salivary Streptococcus mutans levels in patients before, during, and after orthodontic treatment. Am J Orthod Dentofacial Orthop. 1991 Jul;100(1):35-7. doi: 10.1016/0889-5406(91)70046-Y.'}, {'pmid': '11794563', 'type': 'BACKGROUND', 'citation': 'Duggal MS, van Loveren C. Dental considerations for dietary counselling. Int Dent J. 2001;51(6 Suppl 1):408-12. doi: 10.1111/j.1875-595x.2001.tb00588.x.'}, {'pmid': '19491162', 'type': 'BACKGROUND', 'citation': 'Marshall TA. Chairside diet assessment of caries risk. J Am Dent Assoc. 2009 Jun;140(6):670-4. doi: 10.14219/jada.archive.2009.0252.'}, {'pmid': '2179345', 'type': 'BACKGROUND', 'citation': 'Ogaard B. Effects of fluoride on caries development and progression in vivo. J Dent Res. 1990 Feb;69 Spec No:813-9; discussion 820-3. doi: 10.1177/00220345900690S155.'}, {'pmid': '17605483', 'type': 'BACKGROUND', 'citation': 'Knosel M, Attin R, Becker K, Attin T. External bleaching effect on the color and luminosity of inactive white-spot lesions after fixed orthodontic appliances. Angle Orthod. 2007 Jul;77(4):646-52. doi: 10.2319/060106-224.'}, {'pmid': '11125195', 'type': 'BACKGROUND', 'citation': 'Baysan A, Lynch E, Ellwood R, Davies R, Petersson L, Borsboom P. Reversal of primary root caries using dentifrices containing 5,000 and 1,100 ppm fluoride. Caries Res. 2001 Jan-Feb;35(1):41-6. doi: 10.1159/000047429.'}, {'pmid': '3476583', 'type': 'BACKGROUND', 'citation': 'Reynolds EC. The prevention of sub-surface demineralization of bovine enamel and change in plaque composition by casein in an intra-oral model. J Dent Res. 1987 Jun;66(6):1120-7. doi: 10.1177/00220345870660060601.'}, {'pmid': '17208642', 'type': 'BACKGROUND', 'citation': 'Selwitz RH, Ismail AI, Pitts NB. Dental caries. Lancet. 2007 Jan 6;369(9555):51-9. doi: 10.1016/S0140-6736(07)60031-2.'}, {'pmid': '26228178', 'type': 'BACKGROUND', 'citation': 'Sitthisettapong T, Doi T, Nishida Y, Kambara M, Phantumvanit P. Effect of CPP-ACP Paste on Enamel Carious Lesion of Primary Upper Anterior Teeth Assessed by Quantitative Light-Induced Fluorescence: A One-Year Clinical Trial. Caries Res. 2015;49(4):434-41. doi: 10.1159/000434728. Epub 2015 Jul 29.'}, {'pmid': '6931880', 'type': 'BACKGROUND', 'citation': 'Davidson CL, Bekke-Hoekstra IS. The resistance of superficially sealed enamel to wear and carious attack in vitro. J Oral Rehabil. 1980 Jul;7(4):299-305. doi: 10.1111/j.1365-2842.1980.tb00448.x.'}, {'pmid': '27907894', 'type': 'BACKGROUND', 'citation': 'Hochli D, Hersberger-Zurfluh M, Papageorgiou SN, Eliades T. Interventions for orthodontically induced white spot lesions: a systematic review and meta-analysis. Eur J Orthod. 2017 Apr 1;39(2):122-133. doi: 10.1093/ejo/cjw065.'}, {'pmid': '39907699', 'type': 'DERIVED', 'citation': 'Wan Hassan WN, Tee YY, Md Razali K, Abdul Razak AA, Lim HH, Zakaria N, Sukumaran P, Mohd Tahir NNZ, Chew HP. A 12-months randomized clinical trial comparing fluoride-based remineralising protocols on post-orthodontic initial caries lesions. Clin Oral Investig. 2025 Feb 5;29(2):111. doi: 10.1007/s00784-025-06172-0.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nMany 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.\n\nTwo 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.\n\nA 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.", 'detailedDescription': "Rationale of the study :\n\nCurrently 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.\n\nThe study aims to determine the effect of different remineralizing agents on white spot lesions and dental plaque of post-orthodontic treatment patients.\n\nThe objectives are:\n\n1. 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\n2. To compare the bacterial count (including streptococcus and lactobacillus) in subjects with white spot lesions treated with different remineralizing agents during orthodontic retention\n3. To compare the salivary profile (flow rate, Ph, buffering capacity) in subjects with white spot lesion treated with different remineralizing agents during orthodontic retention\n\nSample size calculation :\n\nSample 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.\n\nMethodology :\n\nA. Subjects screening and preparation\n\nOrthodontic 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:\n\nGroup 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.\n\nGroup 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.\n\nGroup 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.\n\nDuring the first appointment (T0),\n\n1. Debond procedure will be done according to the standard protocol.\n2. Two sets of impression will be taken for the construction of study model, construction of the standard retainers and also for the research purpose.\n3. 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.\n4. The salivary profile (flow rate, Ph, buffering capacity) will be measured using Saliva- Check BUFFER (GC America) according to the manufacturer's instruction.\n5. Plaque samples will be collected with sterile swabs from the enamel surface of each tooth with the identified WSL to measure the bacterial count.\n\n1 day after T0,\n\n1. 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.\n2. ICDAS score and optical changes (lesion depth and integrated refractivity) of the white spot lesion will be measured.\n3. Participants will be given a set of questionnaires to assess the compliance to the remineralizing agent application and perception on the WSL.\n\nTreatment follow up\n\n1. 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)\n2. During the follow up visit , each participant will be subjected to the measurement of :\n\n * tooth surface changes\n * bacterial count\n * salivary profile\n * intraoral photos of maxillary teeth\n3. 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\n\nStatistical Analysis\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects on multibracket fixed appliance treatment\n* Subjects with 2 or more bracketed surfaces with labial subsurface WSLs from\n* upper right permanent canine (13) to upper left permanent canine (23) with an ICDAS II score of 1 and 2 will be selected.\n* Indicated for thermoform or vacuum formed retainers on the upper arch.\n\nExclusion Criteria:\n\n* Systemic diseases or any physical anomalies.\n* Subjects with intention to move out from Klang Valley area for the next 1.5 years.\n* Periodontal diseases (pocket depth of more than 3mm).\n* Smoker.\n* Severe fluorosis or any enamel abnormalities.\n* Antimicrobial agents or antibiotic therapy within the past 3 months.\n* Orthognathic surgery cases, cleft lip and palate.\n* Single arched lower fixed orthodontic treatment.\n* Milk protein and benzoate preservatives (a common preservatives) allergies.'}, 'identificationModule': {'nctId': 'NCT04788550', 'briefTitle': 'The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DGD_190005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Toothpaste group', 'description': 'Control group using fluoridated toothpaste', 'interventionNames': ['Combination Product: Fluoridated toothpaste']}, {'type': 'EXPERIMENTAL', 'label': 'Fluoride Varnish group', 'description': 'Fluoride varnish (5% sodium fluoride) application on 3 months interval', 'interventionNames': ['Combination Product: fluoride varnish (5% sodium fluoride)']}, {'type': 'EXPERIMENTAL', 'label': 'CPP-ACP plus crème group', 'description': 'CPP-ACP plus crème application 2 times daily', 'interventionNames': ['Combination Product: CPP-ACP plus crème group']}], 'interventions': [{'name': 'Fluoridated toothpaste', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Colgate® Maximum cavity protection great regular flavour'], '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.', 'armGroupLabels': ['Toothpaste group']}, {'name': 'fluoride varnish (5% sodium fluoride)', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Colgate Duraphat 22,600 ppmF', '22,600 ppm Sodium Fluoride varnish'], '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.', 'armGroupLabels': ['Fluoride Varnish group']}, {'name': 'CPP-ACP plus crème group', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['GC Tooth Mousse Plus®'], '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.', 'armGroupLabels': ['CPP-ACP plus crème group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50603', 'city': 'Kuala Lumpur', 'state': 'WP Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Najwa Zakaria', 'role': 'CONTACT', 'email': 'najwazakaria87@yahoo.com', 'phone': '0176476058'}, {'name': 'Wan Nurazreena Wan Hassan', 'role': 'CONTACT', 'email': 'wannurazreena@um.edu.my', 'phone': '0379674802'}], 'facility': 'Postgraduate Orthodontic Clinic, Faculty Of Dentistry, University Of Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Najwa Zakaria', 'role': 'CONTACT', 'email': 'najwazakaria87@yahoo.com', 'phone': '0176476058'}, {'name': 'Wan Nurazreena Wan Hassan', 'role': 'CONTACT', 'email': 'wannurazreena@um.edu.my', 'phone': '0379674802'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry', 'investigatorFullName': 'Dr Wan Nurazreena Wan Hassan', 'investigatorAffiliation': 'University of Malaya'}}}}