Caries,DentalNCT06826456
Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
A study testing sub-ablative Er,Cr:YSGG laser and Fluoride varnish application in people with Caries,Dental, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- sub-ablative Er,Cr:YSGG laser and Fluoride varnish application
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria
Hussein Ezz Eldin
About this study
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.
- Conditions
- Caries,Dental
- Being tested
- sub-ablative Er,Cr:YSGG laser, Fluoride varnish application
- Keywords
- Er,Cr:YSGG, laser, DIAGNOdentTM, acid resistance
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sub-ablative Er,Cr:YSGG laserProcedure or surgery
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
Fluoride varnish applicationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser irradiation | Experimental | First permanent molars subjected to sub-ablative Er,Cr:YSGG laser Receives: Procedure: sub-ablative Er,Cr:YSGG laser |
| Fluoride Varnish | Active comparator | First permanent molars subjected to fluoride varnish application Receives: Procedure: Fluoride varnish application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 0, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Jan 2024
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Ezz, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826456
- Sponsor's protocol ID
- 10556-0008839
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
- ClinicalTrials.gov ID
- NCT06826456
- Acronym / sponsor ID
- 10556-0008839
- Conditions
- Caries,Dental
- Keywords
- Er,Cr:YSGG, laser, DIAGNOdentTM, acid resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser irradiation | Experimental | Procedure: sub-ablative Er,Cr:YSGG laserFirst permanent molars subjected to sub-ablative Er,Cr:YSGG laser |
| Fluoride Varnish | Active comparator | Procedure: Fluoride varnish applicationFirst permanent molars subjected to fluoride varnish application |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sub-ablative Er,Cr:YSGG laserThe 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 | Procedure or surgery | Laser irradiation |
| Fluoride varnish applicationThe 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. | Procedure or surgery | Fluoride Varnish |
Primary outcome
Diagnodent scoring
Time frame: day 0, 3 months, 6 months, 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sub-ablative Er,Cr:YSGG laser and Fluoride varnish application in people with Caries,Dental, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hussein Ezz Eldin (+20 10 92403402, hussein.ezz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnodent scoring (time frame: day 0, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.