An interventional study of sub-ablative Er,Cr:YSGG laser and Fluoride varnish application in Caries,Dental, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
Background: Subjecting human dental enamel to sub-ablative laser has been suggested as a novel way of caries prevention. However, further studies are needed to establish its use as a routine clinical procedure for caries prevention.
The aim of this study: This study aims to evaluate the effect of Er,Cr:YSGG subablative laser irradiation on caries resistance of occlusal fissures of permanent molars.
Materials and methods: In-vivo study, a split mouth randomized controlled trial with sixty patients having two fully erupted bilateral first permanent molars (ICDAS-II score 0,1 or 2). The pits and fissures will be subjected to sub-ablative power of Er,Cr:YSGG Laser (Group 1, n=90) and will be compared with fluoride varnish application on the first permanent molars in the same arch(Group 2,n=90). DIAGNOdentTM readings and changes in ICDAS-II score will be assessed at base line and at 3,6,9 and 12 months follow-up.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 936 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Alexandria University is the lead sponsor of 586 studies on the registry; 128 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
First permanent molars subjected to sub-ablative Er,Cr:YSGG laser
Procedure: sub-ablative Er,Cr:YSGG laser
First permanent molars subjected to fluoride varnish application
Procedure: Fluoride varnish application
The irradiations will be done with an Er,Cr:YSGG laser device Er,Cr:YSGG Laser (Waterlase iPlus 2011,Biolase,Germany). This equipment emits photons at a wavelength of 2.78 µm. The repetition rate will be fixed at 20 Hz. The pulse duration will be fixed on 140 µs. The beam diameter at the focal area for the handpiece will be 600 µm. The tip will be positioned 1.0 mm from the enamel surface (focused mode). The handpiece will be positioned perpendicularly to the enamel. Power =0.25 Watt; energy density per pulse will be 62.5 J/cm2, Time = 20 seconds; Frequency = 20 Hz; without air/water. To ensure that each spot of a fissure was irradiated, each fissure will be irradiated for 2 min with overlapping irradiation
The first permanent molar assigned for control group will receive fluoride varnish applications. Fluoride varnish will be applied to all teeth in the oral cavity, including the laser-treated as well as the control tooth at baseline and the 6-month recall. Parents and children will be given age-appropriate oral hygiene instructions including proper teeth brushing with a 1100-ppm fluoride-containing dentifrice for at least 2 min twice daily especially before bedtime, as well as flossing if indicated.
Diagnodent scoring
evaluate the dental caries activity of fissures by comparing changes in DIAGNOdent readings. Laser induced fluorescence (DIAGNOdentTM) will be used to quantitatively determine lesion demineralization which is displayed as numerical values ranging from 0 to 99. A decrease in the signal indicates regression of the carious lesion, whereas an increase indicates progression. The DIAGNOdent tip will be then placed on the measurement site, and slightly tilted circular movements will be performed along the entire fissure pattern. The patient will be included in the study if the DIAGNOdent readings of both bilateral first permanent molar do not exceed 25.
Time frame: day 0, 3 months, 6 months, 12 months
Plan to share: Undecided
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