Evaluation of Orthodontic Bands Coated With Nano-silver Fluoride
White Spot Lesion of Tooth · Pocket, Periodontal · Dental Caries Tooth Demineralization
De qué trata este estudio
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- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- No especificado - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 25 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
1. Aim of the Study To evaluate the antibacterial and enamel remineralization effects of nano-silver fluoride-coated orthodontic bands compared with conventional non-coated bands in orthodontic patients over 6 months.
2. What Will I Do in This Study?
* Conduct a randomized split-mouth clinical trial involving 25 patients.
* Place orthodontic bands on the maxillary first molars, with one band coated and the contralateral band left uncoated as the control.
* Randomize the right or left side receiving the coated band.
* Collect dental plaque samples after 24 hours, 3 months, and 6 months to measure bacterial counts, particularly Streptococcus mutans, using colony-forming unit (CFU) counting.
* Assess enamel demineralization and remineralization using DIAGNOdent measurements before band placement and after band removal.
3. Materials Used
- Orthodontic bands: Stainless steel molar bands.
- Silver nanoparticles (AgNPs): Concentration of 5 µg/mL, with an average particle size of 40 nm.
- Fluoride: Concentration of 5 ppm.
- Coating technique: Dip coating, followed by air-drying and incubator drying.
Leer la descripción completa
1. Background Fixed orthodontic appliances, particularly orthodontic molar bands, contribute significantly to increased plaque retention and bacterial accumulation around the teeth. This heightens the risk of enamel demineralization and the formation of white spot lesions (WSLs). Streptococcus mutans is considered one of the primary etiologic agents in this process, owing to its ability to produce acids that lower plaque pH and initiate enamel demineralization.
Because conventional preventive measures rely heavily on patient compliance and optimal oral hygiene, research has shifted toward developing orthodontic materials with intrinsic antibacterial properties. Nano-Silver Fluoride (NSF)-which combines silver nanoparticles with fluoride-presents a promising agent, as it is expected to reduce bacterial colonization while promoting enamel remineralization. However, clinical evidence evaluating its direct application as a coating on orthodontic molar bands remains limited.
2. Aim of the Study This split-mouth clinical trial aims to evaluate the antibacterial efficacy and enamel remineralization potential of stainless steel orthodontic molar bands coated with Nano-Silver Fluoride compared to uncoated bands during active orthodontic treatment.
3. Interventions This study will be conducted on 25 patients using a split-mouth design, where each patient will receive a coated molar band on one maxillary first molar and an uncoated band on the contralateral maxillary first molar, with side allocation determined through randomization.
Experimental Group: Stainless steel molar bands coated with a Nano-Silver Fluoride solution containing silver nanoparticles (5 µg/mL concentration, 40 nm particle size) and fluoride (5 ppm concentration).
Control Group: Conventional, uncoated stainless steel molar bands.
Coating Method: Dip-coating technique, where the bands are thoroughly cleaned, submerged in the NSF solution for a specified duration, air-dried, and subsequently oven-dried to ensure a stable coating layer.
Assessment of Antibacterial Effect: Plaque samples will be collected from the area surrounding the bands to quantify Streptococcus mutans levels using Colony-Forming Units (CFU) at 24 hours, 3 months, and 6 months.
Assessment of Enamel Remineralization: Changes in white spot lesions and enamel demineralization levels will be measured using DIAGNOdent before band placement and after band removal according to the study's follow-up schedule.
4. Summary / Conclusion This study investigates the feasibility of transforming orthodontic molar bands from passive mechanical retention devices into active preventive components that combine antibacterial activity with the preservation of enamel integrity during orthodontic therapy.
¿Quién podría participar?
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Inclusion Criteria:
- • Patients presenting with malocclusion, including crowding, spacing, increased overjet or overbite, crossbite, or open bite.
- Presence of a sufficient number of erupted permanent teeth to allow effective placement and retention of orthodontic appliances.
- Good oral and periodontal health, with no active caries or untreated periodontal disease.
- Systemically healthy patients, or those with controlled medical conditions that do not contraindicate orthodontic tooth movement.
- Patients demonstrating adequate motivation and willingness to cooperate, including maintaining oral hygiene and attending regular follow-up visits.
Exclusion Criteria:
- • Presence of active dental caries or Poor oral hygiene.
- Active periodontal disease, including gingivitis or periodontitis with attachment loss.
- Patients with uncontrolled systemic diseases that may affect bone metabolism or healing (e.g., uncontrolled diabetes, metabolic bone disorders).
- Use of medications that adversely affect orthodontic tooth movement and cannot be medically managed.
- Insufficient erupted teeth to support orthodontic appliances.
- Low motivation or poor compliance, including failure to attend appointments or follow treatment instructions.
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
Nano-silver Fluoride Coated Orthodontic Bands
Participants receiving orthodontic bands coated with Nano-silver Fluoride (NSF).
Device: Nano-silver Fluoride Coated Orthodontic Bands
Uncoated Orthodontic Bands
Participants receiving conventional uncoated orthodontic bands.
Other: Conventional Uncoated Orthodontic Bands
Nano-silver Fluoride Coated Orthodontic Bands DEVICE
Orthodontic bands coated with Nano-silver Fluoride (NSF) solution applied to cementation to evaluate antibacterial and remineralization effects.
Conventional Uncoated Orthodontic Bands OTHER
Standard uncoated orthodontic bands were used as a control group.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change from baseline in Streptococcus mutans count in plaque around the band
Plazo: Baseline, 3 months, and 6 months post-placement.
Plaque samples will be collected from around the orthodontic band to quantify Streptococcus mutans levels using Colony Forming Units (CFU/mL) count.
Medidas secundarias
Remineralization Effect
Plazo: Baseline, 3 months, and 6 months post-placement.
The incidence and severity of white spot lesions on the first molars will be assessed using laser fluorescence (DIAGNOdent).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Mansoura universityAl Mansurah, EgyptEstado desconocido
Equipo y fechas
- Patrocinador principal
- Ebrahim N Abbas
- Inicio del estudio
- 8 ago 2026 Real
- Finalización primaria
- 8 feb 2027 Estimado
- Finalización del estudio
- 8 mar 2027 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Evaluation of Antibacterial and Remineralization Effect of Orthodontic Bands Coated With Nano-silver Fluoride: A Randomized Controlled Clinical Trial
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026