Actively Recruiting
Clinical Evaluation of Two Different Pit and Fissure Sealants Used in Teeth Affected by Molar Incisor Hypomineralization
Led by Baskent University · Updated on 2025-01-17
126
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research involves children aged 6 to 12 years with molar incisor hypomineralization who visit a pediatric dentistry clinic for routine dental care. The study aims to compare two types of pit and fissure sealants to evaluate their effectiveness and patient comfort during dental treatment. The trial is randomized and single-blind, focusing on teeth that have early enamel defects diagnosed using established pediatric dental criteria. Participants will receive one of two treatments: a conventional resin-based fissure sealant applied after etching the tooth surface with phosphoric acid, or a self-adhesive flowable composite applied in one step. Both types of sealants are polymerized with a light device, and occlusion is checked with articulation paper. The treatments will be evaluated at 1, 3, 6, and 12 months to assess sealant retention and quality. Children will undergo dental examinations using standardized criteria for evaluating tooth decay and enamel condition. Sensitivity of treated teeth will be measured using a cold air sensitivity scale. Researchers will monitor sealant success based on various factors including form, adaptation, texture, color, retention, and presence of secondary caries. The total follow-up period for each participant is 12 months, during which clinical evaluations will be performed regularly to assess treatment outcomes and tooth sensitivity.
CONDITIONS
Brief Title
Clinical Evaluation of Two Different Pit and Fissure Sealants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy children aged 6-12 years
- At least two fully erupted permanent first molars diagnosed with molar incisor hypomineralization according to European Academy of Paediatric Dentistry criteria
- Hypomineralized first molars with enamel defects consistent with early lesions
You will not qualify if you...
- Ongoing orthodontic treatment
- Uncooperative child during dental treatment
- Teeth with advanced lesions, existing restorations, fluorosis, or enamel malformation due to syndromic causes
- Presence of pulpal symptoms
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.
1 visit (in-person)
Duration - Single treatment visit with follow-up over 12 months
Participants receive either a resin-based flowable fissure sealant or a self adhesive flowable composite fissure sealant applied to molar teeth affected by hypomineralization.
1 treatment visit and multiple follow-up visits over 12 months
Duration - Up to 12 months
Participants are monitored for up to 12 months after treatment to assess sealant performance and sensitivity.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Başkent University
Ankara, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Simge POLAT, Lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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