An interventional study of Nano-silver Fluoride Coated Orthodontic Bands and Conventional Uncoated Orthodontic Bands in White Spot Lesion of Tooth, Pocket, Periodontal and Dental Caries Tooth Demineralization, sponsored by Ebrahim N Abbas. Active, not recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Ebrahim N Abbas · Not applicable, Interventional, and Prevention
What Will I Do in This Study?
Materials Used
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.
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.
130 studies on the registry are indexed under Periodontal Pocket; 35 are open to participants now.
This study's enrollment of 25 is below the median of 30 across 113 interventional studies indexed under Periodontal Pocket.
Browse Periodontal Pocket studies →This is the only study on the registry with Ebrahim N Abbas as lead sponsor.
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Patients presenting with malocclusion, including crowding, spacing, increased overjet or overbite, crossbite, or open bite.
Exclusion Criteria:
Presence of active dental caries or Poor oral hygiene.
Participants receiving orthodontic bands coated with Nano-silver Fluoride (NSF).
Device: Nano-silver Fluoride Coated Orthodontic Bands
Participants receiving conventional uncoated orthodontic bands.
Other: Conventional Uncoated Orthodontic Bands
Orthodontic bands coated with Nano-silver Fluoride (NSF) solution applied to cementation to evaluate antibacterial and remineralization effects.
Standard uncoated orthodontic bands were used as a control group.
Change from baseline in Streptococcus mutans count in plaque around the band
Plaque samples will be collected from around the orthodontic band to quantify Streptococcus mutans levels using Colony Forming Units (CFU/mL) count.
Time frame: Baseline, 3 months, and 6 months post-placement.
Remineralization Effect
The incidence and severity of white spot lesions on the first molars will be assessed using laser fluorescence (DIAGNOdent).
Time frame: Baseline, 3 months, and 6 months post-placement.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2027, 6 months after the start.
Of 59 non-industry interventional studies with no phase under Periodontal Pocket, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's planned 6 months is below that.
Counting every sponsor, half of 63 studies reached it within 16 months; a quarter within 9 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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