Actively Recruiting
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
Eligibility Criteria
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)
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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