Clinical Evaluation of Two Different Pit and Fissure Sealants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorBaskent University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resin-based flowable filling material

    Other intervention

    Preventive restoration

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Application of resin composite fissure sealantExperimental treatment 1 intervention
Group B: Application of self adhesive flowable composite fissure sealantActive comparator 1 intervention

Trial outcomes

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.

Time frame
up to 12 month

Secondary outcomes

1

Using The Schiff Cold Air Sensitivity Scale test

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. When evaluating this test, the patient will receive a minimum score of 0 and a maximum score of 3. The patient's response will be recorded as follows: 0 = the person does not respond to the stimulus; 1 = the person does not respond to the stimulus but feels the stimulus is painful; 2 = the person responds to the air stimulus and moves away from the stimulus, and 3 = the person responds to the air stimulus, moves away from the stimulus, and requests that the stimulus stop immediately.

Time frame
12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.