Effect of BG Versus RI on the Depth of WSL

ConditionWhite Spot Lesions

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age15-35

SponsorRiphah International University

About this trial

The aim of this in vitro study is to assess the mean lesion depth improvement and hardness of artificial white spot lesions by comparing the effects of bioactive glass toothpaste and resin infiltration (ICON).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Upper and lower premolars will be collected from patients undergoing extractions.

The teeth should be healthy with no carious lesions.

The crown and root morphology of teeth should be normal.

The extracted premolar teeth of patients should have no history of previous dental treatment.

Disqualifiers

• Fractured premolars due to any cause.

Loss of enamel due to parafunctional habits.

Presence of enamel anomalies (amelogenesis imperfecta, hypoplasia etc.).

Presence of stains, demineralization, decay, fluorosis and restorations

Trial design

Design model

Parallel

Treatments tested in this trial

Bioactive Glass (NovaMin)
Other intervention
A carbonated beverage (Coca Cola, Pakistan ltd) will be used for artificial white spot lesion formation. The pH of the beverage will be 4-4.5 at 37ºC. The teeth will be immersed in demineralization solution for 4 weeks before treatment. The solution will be changed every 48 hrs. to keep the pH constant. After demineralization specimens will be washed with distilled deionized water (DDW). The tooth will have a white spot lesion only on the buccal surface. A sufficient amount of 5% bioactive glass (Biomin F T/P) was applied on the tooth surface for three minutes using a tooth brush. The toothpaste remained on the surface for an additional 30 minutes.
Resin Infiltration (ICON)
Other intervention
A carbonated beverage (Coca Cola, Pakistan ltd) was used for artificial white spot lesion formation. The pH of the beverage was 4-4.5 at 37ºC. The teeth were be immersed in demineralization solution for 4 weeks before treatment. The solution was changed every 48 hrs. to keep the pH constant. After demineralization specimens were washed with distilled deionized water (DDW). The tooth would have a white spot lesion only on the buccal surface. Resin infiltration (ICON) infiltration will be applied according to manufacture as following: * Application of Icon Etch (15% HCL gel) for 2 minutes. * Water rinsing and air drying for 30 sec. * Application of Icon-dry (ethanol) for 30 sec. * Air drying * Application of Icon Infiltrant for 3 minutes. * Light curing for 40 seconds.
Fluoride Toothpaste
Other intervention
A carbonated beverage (Coca Cola, Pakistan ltd) was used for artificial white spot lesion formation. The pH of the beverage will be 4-4.5 at 37ºC. The teeth were immersed in demineralization solution for 4 weeks before treatment. The solution was changed every 48 hrs. to keep the pH constant. After demineralization specimens was washed with distilled deionized water (DDW). The tooth would have a white spot lesion only on the buccal surface. The teeth were cleaned and dried first. 5% Sodium fluoride (Enamelist) varnish was applied on tooth surface with disposable tooth brush. The varnish remained undisturbed on teeth for 4 hours.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Bioactive glassActive comparator 1 intervention

Group B: Resin Infiltration(ICON)Active comparator 1 intervention

Group C: Fluoride toothpastePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Scanning Electron Microscopy

Changes in baseline lesion depth were assessed using scanning electron microscopy. Scanning electron microscopy is used to assess lesion depth before and after treatment with remineralizing agents. Lesion depth is measured in microns. Comparison is made by calculating the average depth of treated samples against untreated demineralized control samples.

Time frame

4th week

Vickers Microhardness Test

Changes from baseline microhardness tests are used to measure changes in surface hardness before and after remineralization. Sound or artificially demineralized enamel (acid-etched or caries-like lesions) is tested first to set a control value. Agents like fluoride varnishes, CPP-ACP (Casein Phosphopeptide-Amorphous Calcium Phosphate), or bioactive glass are applied over cycles. The percentage surface hardness measures how much demineralized enamel is hardened after remineralization treatment relative to original healthy baseline.

Time frame

4th week

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riphah International University

Lead sponsor

Source ClinicalTrials.gov

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