Pediatric Fiberglass Crown in Primary Teeth

Akdeniz University

Status: Completed

Conditions: Dental Plaque; Dental Caries

Treatments: Procedure: Cementation; Procedure: Tooth Preperation

Study type: Interventional

Funder types: Other

Identifiers

NCT06558734

TDH-2020-5280

Details and patient eligibility

About

This randomized controlled clinical trial aims to evaluate the clinical success of fiberglass crowns applied to primary teeth and to assess the impact of two different luting cements on the success of the fiberglass crowns. The main questions to answer are:

• Will fiberglass crowns demonstrate sufficient clinical success to serve as a viable alternative to existing pediatric crowns?
• Will there be any differences in the clinical success and mechanical properties of fiberglass crowns based on the type of luting cement used?

Thirty-eight children (60 teeth), between 5 and 9 years old (7.03±1.14), enrolled for the study. The researchers evaluated the clinical success of fiberglass crowns bonded with two different types of luting cement (1: FujiOne; 2: FujiCEM 2) based on retention, anatomical integrity, effect on periodontal health and parental satisfaction.

Participants will:

-Visit the clinic 1st, 3rd, 6th, 12th months after cementatiton.

Enrollment: 38 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For participants:

• absence of any systemic disease
• absence of any periodontal disease
• no unilateral chewing habit
• a Frankl scale score of three-four

For teeth:

• no percussion or palpation sensitivity
• no malocclusion
• no pathological mobility
• no pulpal treatment due to caries or other reasons
• had sound cervical margins
• not hypoplastic or hypocalcified
• had opposing functioning teeth
• had physiological root resorption not exceeding one-third of the root length
• had deep dentin caries with two or more surface that do not contain pulp involvement

Exclusion criteria

• did not attend their follow-up appointments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Device: Glass-ionomer cement

Experimental group

Description:

The capsule was attached to the mixer and mixed for 10 seconds. The cement was evenly distributed to the crowns paying attention that there were no air voids. Then crowns were placed by pressing them onto the prepared teeth with finger pressure. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set.

Treatment:

Procedure: Tooth Preperation

Procedure: Cementation

Device: Resin-modified glass-ionomer cement

Experimental group

Description:

FujiCEM 2 (GC, Tokyo, Japan) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth with finger pressure. The crowns were placed on the prepared tooth. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set.

Treatment:

Procedure: Tooth Preperation

Procedure: Cementation