Actively Recruiting

Phase Not Applicable
Age: 6Years - 9Years
All Genders
Healthy Volunteers
ID06801561

Evaluation of Preventive Effect of Glass Ionomer Sealants and Laser Therapy on Dental Caries and Post-Eruptive Breakdown in Molars Affected by Molar Incisor Hypomineralisation (Randomized Clinical Trial)

Led by Alexandria University · Updated on 2025-01-30

134

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate and compare the preventive effects of glass ionomer sealant and laser therapy on dental caries and post-eruptive breakdown (PEB) in molars affected by molar incisor hypomineralisation (MIH). MIH is a defect of tooth enamel affecting one to four first permanent molars, sometimes involving incisor teeth, making these molars prone to damage and caries. The study involves children aged 6 to 9 years old with affected molars but no existing caries or PEB. Participants will be randomly divided into two groups: one receiving laser therapy using a specific laser device applied to the tooth surface for 20 seconds under safety measures, and the other receiving a glass ionomer sealant after surface conditioning, light curing, and occlusion adjustment. Both treatments are applied to the first permanent molars with MIH to prevent dental issues. Evaluations will occur at 6, 12, and 18 months after treatment. During the study, dental health including caries, PEB, sealant retention, and patient discomfort will be assessed at the scheduled follow-ups. Researchers will analyze the relationships between caries, PEB, and treatments using statistical methods. The main outcome measure is the presence of post-eruptive breakdown or dental caries after 21 months. Participation involves regular dental examinations and monitoring over this period.

CONDITIONS

Brief Title

EVALUATION of PREVENTIVE EFFECT of SEALANTS and LASER THERAPY on DENTAL CARIES and POSTERUPTIVE BREAKDOWN on MOLARS AFFECTED with MOLAR INCISOR HYPOMINERALISATION (RANDOMIZED CLINICAL TRIAL)

Who Can Participate

Age: 6Years - 9Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 9 years old
  • Presence of one first permanent molar with molar incisor hypomineralisation without post-eruptive breakdown
  • Teeth with ICDAS scores 0, 1, or 2 indicating no or early caries
  • Good overall health (ASA I classification)
Not Eligible

You will not qualify if you...

  • First permanent molars with active carious lesions having ICDAS scores 5 or 6
  • Teeth with defective restorations
  • Teeth with sufficient dentin loss requiring restorative therapy
  • Presence of clinical signs of failure such as abscess or fistula

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single treatment session with follow-up over 21 months

Participants receive either laser therapy or glass ionomer sealant on affected molars to prevent dental caries and post-eruptive breakdown.

1 treatment visit and periodic follow-up visits over 21 months

Trial Site Locations

Total: 1 location

1

Alexandria University

Alexandria, Egypt

Actively Recruiting

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Research Team

M

Marwa Baraka

R

Rodaina H Helmy

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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