Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars (NCT06826456) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
Egypt60 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.