Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
Healthy Volunteers
ID06826456

Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars

Led by Alexandria University · Updated on 2025-02-14

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of sub-ablative Er,Cr:YSGG laser irradiation on preventing dental caries in the grooves of permanent molars. This study is a split-mouth randomized controlled trial involving children aged 6 to 12 years who have fully erupted first permanent molars without significant decay. The trial compares laser treatment to fluoride varnish application to investigate their impact on caries resistance over time. Participants will receive two types of treatments on their molars: one side will be treated with the sub-ablative Er,Cr:YSGG laser, which involves precise laser irradiation of the tooth surface without air or water cooling for 2 minutes per fissure. The other side will receive fluoride varnish applied to all teeth, including laser-treated and control teeth, at the start and again at 6 months. Oral hygiene instructions will be provided to both parents and children. Throughout the 12-month study, participants will have their teeth assessed at baseline and at 3, 6, 9, and 12 months using DIAGNOdent readings and ICDAS-II scoring to monitor changes in caries development. The study collects data on enamel resistance to decay and oral health status. Parents must consent and commit to study procedures, and safety monitoring is included. Participation involves regular dental visits and assessments over one year.

CONDITIONS

Brief Title

Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars

Who Can Participate

Age: 6Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 6 to 12 years
  • Positive or definitely positive behavior on Frankl scale
  • Having at least two fully erupted bilateral first permanent molars with untreated non-cavitated deep grooves
  • Teeth with ICDAS-II scores of 0, 1, or 2
  • Initial DIAGNOdent score not exceeding 25 indicating only enamel involvement
  • Parents willing to comply with study procedures and provide informed consent
Not Eligible

You will not qualify if you...

  • Known medical history of systemic diseases
  • First permanent molars with hypoplastic or hypocalcified enamel
  • Use of medications affecting oral flora or salivary flow
  • In-office fluoride treatment within 3 months prior to enrollment
  • Evidence of poor oral hygiene according to Silness and Löe plaque index

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single session at baseline with follow-up assessments up to 12 months

Participants receive either sub-ablative Er,Cr:YSGG laser irradiation or fluoride varnish application on their first permanent molars, along with oral hygiene instructions.

1 baseline visit and 3 follow-up visits at 3, 6, and 12 months

Trial Site Locations

Total: 1 location

1

Alexandria University

Alexandria, Egypt

Actively Recruiting

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Research Team

H

Hussein Ezz Eldin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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