Clinical Evaluation of Two Different Pit and Fissure Sealants

NCT06776471 | Recruiting DMC

• 1 other identifier: 2024-121
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

It is planned to include girls and boys between the ages of 6-12 who apply to Başkent University Faculty of Dentistry, Pediatric Dentistry Clinic for routine dental examination. Informed and written consent will be obtained from the parents of each participating child. In teeth planned to undergo treatment, molar ıncisor hypomineralization diagnosis will be made primarily in the presence of limited opacities/enamel fracture after eruption in at least one first permanent molar according to European Academy of Paediatric Dentistry criteria. In teeth diagnosed with molar ıncisor hypominerlization, tooth surfaces will be cleaned with a slow-speed rotary brush and dried with air before the evaluations to be made using the ICDAS II index. Early enamel caries lesions will be assessed by visual examination. The decayed, missing, filled teeth of the patients will be assessed according to the World Health Organization assessment criteria. The groups will be double-blind randomized as conventional fissure sealant (n=63) and self-adhesive flowable composite (n=63): Group I (acid+resin-based fissure sealant) will be etched with 37% phosphoric acid for 30 seconds, the surface will be rinsed and air dried until an opaque appearance is achieved on the enamel. Low-viscosity fluoride containing resin based fissure sealant will be applied to the etched enamel surface. Group II (self-adhesive flowable composite); self adhesive flowable composite will be applied in one step. All applied fissure sealants will be polymerized using a light device. Finally, occlusion control will be performed on fissure sealants with articulation paper.The Schiff Cold Air Sensitivity Scale will be used to assess the presence of hypersensitivity in the affected teeth by applying the air-water spray perpendicular to the occlusal surface of the tooth from a distance of 1 cm for 1 second. Clinical evaluation of fissure sealants will be performed at 1, 3, 6 and 12 months using modified . Sealants that receive "Alpha" or "Bravo" scores for all criteria (anatomical form, marginal adaptation, surface texture, marginal color change, retention and secondary caries) will be classified as successful; while "Charlie" scores received from one or more of the United States Public Health Service criteria will be evaluated as failure.

Conditions

Pit and Fissure Sealants; Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

• Using United States Public Health Service criteria

  There is no clinical study on the use of self-adhesive flowable composites as fissure sealants in teeth with molar incisor hypomineralization. Therefore, this study contributes to the literature. In this study, it is anticipated that the use of self-adhesive flowable composites will increase as they show similar clinical success to traditional fissure sealants at the end of their 12-month clinical life. Clinical evaluation of fissure sealants will be performed at 1, 3, 6 and 12 months using modified United States Public Health Service criteria. Sealants receiving "Alpha" or "Bravo" scores for all criteria (anatomical form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries) will be classified as successful, while a "Charlie" score for one or more of the United States Public Health Service criteria will be considered as failure.

  up to 12 month

Secondary Outcomes (1)

• Using The Schiff Cold Air Sensitivity Scale test

  12 month

Study Arms (2)

Application of resin composite fissure sealant

EXPERIMENTAL

The occlusal surface will be etched with 37% phosphoric acid for 30 seconds, rinsed, and air dried until the enamel becomes opaque. Low-viscosity fluoride containing resin-based fissure sealant will be applied to the etched enamel surface. All applied fissure sealants will be polymerized using a light device. Finally, occlusion control will be performed on fissure sealants with articulation paper.

Other: Resin-based flowable filling material

Application of self adhesive flowable composite fissure sealant

ACTIVE COMPARATOR

The occlusal surface will be etched with 37% phosphoric acid for 30 seconds, the surface will be rinsed and air dried until an opaque appearance is achieved on the enamel.The occlusal surface self adhesive flowable composite will be applied in one step. All applied fissure sealants will be polymerized using a light device. Finally, occlusion control will be performed on fissure sealants with articulation paper.

Other: Resin-based flowable filling material

Interventions

Resin-based flowable filling material OTHER

Preventive restoration

Application of resin composite fissure sealant; Application of self adhesive flowable composite fissure sealant

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 6-12 years with at least two fully erupted permanent first molars diagnosed with molar ıncisor hypomineralization according to the European Academy of Paediatric Dentistry criteria.
• Hypomineralized first molars with enamel defects according to early lesions

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Başkent University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Van der Woude syndrome; Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Simge POLAT, Lecturer

  Baskent University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simge POLAT, Lecturer

CONTACT

+90 312 203 00 00; simgepolat@baskent.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 15, 2025
• Study Start: November 18, 2024
• Primary Completion: November 18, 2025
• Study Completion: December 18, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)