A Phase 4 interventional study of 5% sodium fluoride and Intensive 5% sodium fluoride in White Spot Lesion, sponsored by Riyadh Elm University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Riyadh Elm University · Phase 4, Interventional, and Treatment
The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Patients will be recruited from Riyadh Elm University's electronic record system and contacted by phone. They will be given an appointment to visit the dental clinic.
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.
Trial design The study will be conducted as a prospective clinical controlled trial with an experimental design, consisting of four parallel groups. Individuals who experienced the development of demineralized white spot lesions after undergoing fixed appliance therapy will be invited to participate in the study and will be assigned to one of the following groups: control group, Fluoride Varnish (FV) group, Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) group, or Resin Infiltration (RI) group.
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
Exclusion criteria
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.
Exclusion Criteria:
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.
Drug: 5% sodium fluoride
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).
Drug: Intensive 5% sodium fluoride
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.
Drug: 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 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.
Drug: Resin infiltration
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.
Also known as: FV EnamelastTM
Intensive FV will be applied three times a week for a week (every two days).
Also known as: EnamelastTM
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
Also known as: (CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan)
resin infiltration will be applied as specified by the manufacturer.
Also known as: ICON® (DMG, Hamburg, Germany)
Change in mineral contents of enamel
The maximum light fluorescence value for each tooth with a white spot lesion will be determined using a DIAGNODent flat tip, following manufacturer's instructions. The DIAGNOdent scale will be used to measure the mineral content of enamel, with values ranging from 0 to 20.
Time frame: Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3)
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Riyadh Elm University