Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
88 participants
INTERVENTIONAL
2023-10-31
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A total of 22 patients with WSLs will be selected for the study. Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system. The level of agreement between the two examiners will be assessed using reliability analysis, with an agreement level of above 80% considered.
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface. WSLs coded 3 or higher will be excluded from further examination and treated accordingly.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RMGI Varnish Versus APF Gel in Prevention of White Spot Lesions During Orthodontic Treatment
NCT03721198
The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
NCT04788550
Remineralization Agents for the Treatment of White Spot Lesions
NCT04827966
White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial
NCT04994314
Evaluation of CPP-ACP Prophylactic Effect on Enamel Surface During Orthodontic Treatment
NCT03187548
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants Patients will be recruited by navigating the electronic record system of Riyadh Elm University from 2023 files backward up to 2022, identifying patients who completed orthodontic treatment reaching up to the required sample size. Those patients will be contacted by phone call from the dental clinic of Riyadh Elm University official number, inviting them to participate in the current study. Patients will be given an appointment to visit the dental clinic at specific time. Before enrollment, every patient or parent/legal guardian of a patient younger than 18 years of age will receive an informational letter and verbal communication about the objectives and protocol of the study. All enrolled patients and/or their parents or legal guardians will be asked to provide a written informed consent following their initial approval. All patients who got treatment in Riyadh Elm University signed consents to share their information for research purposes will be enrolled in the study.
Calibration exercise A total of 22 patients with WSLs attending dental clinics of REU will be selected and two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth to code the WSL against the ICDAS system. Whenever in doubt regarding the coding of the WSLs, the third expert examiner decision will be considered final. The level of agreement with regard to the ICDAS codes between the two examiners will be assessed using reliability analysis and the agreement level of above 80% will be considered.
Two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth. Each WSL will be identified by visual inspection of mesiobuccal, buccal, or distobuccal tooth surfaces and recorded. An ICDAS code will be assigned to each WSL. A digital photograph will be taken by keeping 45 cm distance between subject and camera. The digital image of WS can be captured with a digital camera (Canon EOS 2000D (NIS) DSLR Camera 18 - 55 mm NIS Lens) held almost perpendicular to the buccal surface. Light is supplied by a flash mounted around lens. The camera system setup was adjusted as follows; the quality of image is Fine, ISO is 200, and white balance is speed light mode. Moreover, dental status of the participants also recorded.
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial surface or the distal surface. WSLs that will be coded 3 (denoted by localized enamel breakdown caused by caries without the presence of dentin and underlying shadow), or higher (denoted by the presence of underlying dark shadow caused by dentin, whether enamel-depleting or not, to a large distinct cavity containing visible dentin), in accordance with ICDAS reference, are excluded from further examination and will be appropriately treated.
Following the determination of the 0 LF value for each tooth on a healthy surface, the maximum LF value for each WSL coded tooth (either 1 or 2) will be determined using a DIAGNODent flat tip (KaVo dental, GmbH, Biberach, Germany). Measurements will be done according to the manufacturer's instructions. Each tooth will be dried for 5 seconds, and the tip will be pointed in the opposite direction from the examination area. The measurement will be done using the DIAGNOdent Scale; values 0±13: no caries, values 14±20: enamel caries and values \>20: dentinal caries. (Lussi et al., 2001).
Eligibility criteria for participants Inclusion criteria
1. Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
2. Agreeing to participate in the study by singing the study informed consent.
3. For younger patients parents agree to provide consent for child participation in the study.
Exclusion criteria
1. Developmental defects of dental hard tissue
2. Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
3. Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration. Study settings Data will be collected from orthodontic clinics of Namouthajya and Muneseya hospitals at Riyadh Elm University, Riyadh, Saudi Arabia.
Intervention In group I (Control group): FV EnamelastTM (a flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions: compressed air and cotton rolls will be used to dry the teeth. A mini brush will be used to apply varnish to all teeth surfaces. The varnish will be left to dry for one minute. Patients should avoid eating, drinking, or brushing for a period of 3-4 hours following the application of varnish. In the test groups (group II): Intensive FV will be applied three times a week for a week (every two days). For group III: (CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan) for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water (Thierens et al., 2019). For group IV: ICON® (DMG, Hamburg, Germany) resin infiltration will be applied as specified by the manufacturer: the 15% hydrochloric acid (HCL) solution will be sprayed for 2 minutes, followed by rinsing with water for 30 seconds and drying. Application of ICON-Dry (Ethanol) for 30 seconds, followed by air drying. Subsequently, ICON-Infiltration will be applied to the tooth surface and left for 3 minutes. The excess resin will be removed using a cotton roll, followed by a light curing process lasting for 40 seconds. Finally, the enamel surface that has been roughened will be polished with composite resin polish discs and polish cups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
At the end of treatment for groups II, III, IV, a visual examination and LF measurements (T2) will be conducted by the same examiners. At the next inspection (after 3 months (T3)), LF measurements will be carried out on all areas that were marked as WSL on the original photos, whether they are still existing WSL areas or they will be changed to WSL free areas.
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fluoride Varnish (control)
The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. In group I, FV EnamelastTM will be applied to all teeth using compressed air and cotton rolls, leaving them to dry for one minute. Patients will be advised to avoid eating, drinking, or brushing for 3-4 hours after application.
5% sodium fluoride
a flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions.
Intensive Fluoride Varnish
The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Patients in group II Intensive FV will be applied three times a week for a week (every two days).
Intensive 5% sodium fluoride
Intensive FV will be applied three times a week for a week (every two days).
Casein Phosphopeptide-Amorphous Calcium Phosphate
The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group III (CPP-ACP) uses Tooth Mousse® for 12 weeks, will be applied after daily brushing with traditional toothpaste, left intact for 180 seconds, and rinsed with distilled water.
Casein Phosphopeptide-Amorphous Calcium Phosphate
for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water
Resin Infiltration
The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group IV uses ICON® resin infiltration, applying a 15% hydrochloric acid solution, rinsing with water, drying, and applying ICON-Dry. Excess resin is removed, and a light curing process is performed. The roughened enamel surface is polished using composite resin polish discs and cups.
Resin infiltration
resin infiltration will be applied as specified by the manufacturer.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
5% sodium fluoride
a flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions.
Intensive 5% sodium fluoride
Intensive FV will be applied three times a week for a week (every two days).
Casein Phosphopeptide-Amorphous Calcium Phosphate
for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water
Resin infiltration
resin infiltration will be applied as specified by the manufacturer.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Agreeing to participate in the study by singing the study informed consent.
3. For younger patients parents agree to provide consent for child participation in the study.
Exclusion Criteria
2. Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
3. Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Riyadh Elm University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Samira Fawaz M Algasn
Postgraduate Student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samira Algasn, BDS
Role: PRINCIPAL_INVESTIGATOR
Riyadh Elm University
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.
Ferreira JM, Silva MF, Oliveira AF, Sampaio FC. Evaluation of different methods for monitoring incipient carious lesions in smooth surfaces under fluoride varnish therapy. Int J Paediatr Dent. 2008 Jul;18(4):300-5. doi: 10.1111/j.1365-263X.2007.00879.x.
Lussi A, Megert B, Longbottom C, Reich E, Francescut P. Clinical performance of a laser fluorescence device for detection of occlusal caries lesions. Eur J Oral Sci. 2001 Feb;109(1):14-9. doi: 10.1034/j.1600-0722.2001.109001014.x.
Makhija SK, Bader JD, Shugars DA, Litaker MS, Nagarkar S, Gordan VV, Rindal DB, Pihlstrom DJ, Mungia R, Meyerowitz C, Gilbert GH; National Dental Practice-Based Research Network (PBRN) Collaborative Group. Influence of 2 caries-detecting devices on clinical decision making and lesion depth for suspicious occlusal lesions: A randomized trial from The National Dental Practice-Based Research Network. J Am Dent Assoc. 2018 Apr;149(4):299-307.e1. doi: 10.1016/j.adaj.2017.11.001. Epub 2018 Feb 21.
Melrose CA, Appleton J, Lovius BB. A scanning electron microscopic study of early enamel caries formed in vivo beneath orthodontic bands. Br J Orthod. 1996 Feb;23(1):43-7. doi: 10.1179/bjo.23.1.43.
Migliorati M, Isaia L, Cassaro A, Rivetti A, Silvestrini-Biavati F, Gastaldo L, Piccardo I, Dalessandri D, Silvestrini-Biavati A. Efficacy of professional hygiene and prophylaxis on preventing plaque increase in orthodontic patients with multibracket appliances: a systematic review. Eur J Orthod. 2015 Jun;37(3):297-307. doi: 10.1093/ejo/cju044. Epub 2014 Sep 22.
Aljehani A, Yousif MA, Angmar-Mansson B, Shi XQ. Longitudinal quantification of incipient carious lesions in postorthodontic patients using a fluorescence method. Eur J Oral Sci. 2006 Oct;114(5):430-4. doi: 10.1111/j.1600-0722.2006.00395.x.
Eckstein A, Helms HJ, Knosel M. Camouflage effects following resin infiltration of postorthodontic white-spot lesions in vivo: One-year follow-up. Angle Orthod. 2015 May;85(3):374-80. doi: 10.2319/050914-334.1. Epub 2014 Aug 15.
Kau CH, Wang J, Palombini A, Abou-Kheir N, Christou T. Effect of fluoride dentifrices on white spot lesions during orthodontic treatment: A randomized trial. Angle Orthod. 2019 May;89(3):365-371. doi: 10.2319/051818-371.1. Epub 2019 Feb 5.
Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.
Meyer-Lueckel H, Paris S. Progression of artificial enamel caries lesions after infiltration with experimental light curing resins. Caries Res. 2008;42(2):117-24. doi: 10.1159/000118631. Epub 2008 Feb 28.
Nascimento PL, Fernandes MT, Figueiredo FE, Faria-E-Silva AL. Fluoride-Releasing Materials to Prevent White Spot Lesions around Orthodontic Brackets: A Systematic Review. Braz Dent J. 2016 Jan-Feb;27(1):101-7. doi: 10.1590/0103-6440201600482.
Sonesson M, Brechter A, Lindman R, Abdulraheem S, Twetman S. Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding. Eur J Orthod. 2021 Aug 3;43(4):473-477. doi: 10.1093/ejo/cjaa055.
Related Links
Access external resources that provide additional context or updates about the study.
CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FPGRP/2023/780
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.