NCT06826456 Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
| NCT ID | NCT06826456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexandria University |
| Condition | Caries,Dental |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-01-01 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Participants of age 6-12 years old * Patients ranking definitely positive or positive on Frankl behavior rating scale * Having at least two bilateral fully erupted first permanent molars with untreated non-cavitated occlusal surfaces with deep grooves, the included teeth will have International Detection and Assessment System (ICDAS-II)/ severity scores 0, 1 or 2 * Initial DIAGNOdent Score not exceeding value of 25 indicating only enamel involvement * Patients whom their parents are willing to comply with all study procedures and protocols and will be given an informed consent to participate Exclusion Criteria: * Patients with any known medical history of systemic diseases * Patients having first permanent molar with hypoplastic or hypocalcified enamel * Patients using medications that may affect the oral flora or salivary flow * Patients treated with in-office fluoride treatment within the last 3 months prior to being enrolled in the study. * Patients showing evidence of poor oral hygiene according to Silness and Löe plaque index
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06826456 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Caries,Dental. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06826456 currently recruiting?
Yes, NCT06826456 is actively recruiting participants. Contact the research team at hussein.ezz@hotmail.com for enrollment information.
Where is the NCT06826456 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT06826456 clinical trial?
NCT06826456 is sponsored by Alexandria University. The trial plans to enroll 60 participants.