Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
Healthy Volunteers
ID06776471

Clinical Evaluation of Two Different Pit and Fissure Sealants Used on Teeth with Molar Incisor Hypomineralization

Led by Baskent University · Updated on 2025-01-17

126

Participants Needed

1

Research Sites

56 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating two different types of pit and fissure sealants for treating molar incisor hypomineralization in children aged 6 to 12 years. The study aims to compare a conventional resin-based fissure sealant with a self-adhesive flowable composite to determine their clinical effectiveness and potential to simplify dental treatment while improving patient comfort. The trial focuses on children with at least two fully erupted permanent first molars affected by enamel defects as defined by the European Academy of Paediatric Dentistry criteria. Participants will be randomly assigned to one of two groups: one receiving a traditional resin-based sealant applied after etching the tooth surface with phosphoric acid, and the other receiving a self-adhesive flowable composite applied in a single step. Both treatments will be cured using a light device and occlusion will be checked afterward. The study includes follow-up clinical evaluations at 1, 3, 6, and 12 months to assess sealant success based on criteria such as anatomical form, marginal adaptation, surface texture, color change, retention, and presence of secondary caries. During the trial, participants will undergo dental examinations including cleaning of affected teeth and assessment of early enamel caries using the ICDAS II index. Sensitivity of the treated teeth will be measured using the Schiff Cold Air Sensitivity Scale. The primary outcome will be evaluated using United States Public Health Service criteria over a 12-month period. Researchers will monitor sealant performance and tooth health through clinical visits and assessments, aiming to understand if the self-adhesive flowable composite can offer a quicker, comfortable, and effective alternative for treating affected molars.

CONDITIONS

Official Title

Clinical Evaluation of Two Different Pit and Fissure Sealants

Who Can Participate

Age: 6Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy children aged 6-12 years with at least two fully erupted permanent first molars diagnosed with molar incisor hypomineralization according to the European Academy of Paediatric Dentistry criteria.
  • Hypomineralized first molars with enamel defects according to early lesions
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Başkent University

Ankara, Turkey (Türkiye)

Actively Recruiting

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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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