Pediatric Fiberglass Crown in Primary Teeth

NCT ID: NCT06558734

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-11-23

Brief Summary

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.

Conditions

Dental Caries; Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Device: Glass-ionomer cement

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.

Group Type: EXPERIMENTAL

Tooth Preperation

Intervention Type: PROCEDURE

After the caries were removed, the teeth were prepared according to the manufacturer's recommendations for Figaro Crowns. Fiberglass crowns (Figaro Crowns Inc., USA) of the most suitable size in terms of the mesio-distal dimension of the tooth were selected. Following the establishment of anesthesia, the teeth were prepared using diamond cutting burs with a high-speed, water-cooled turbine handpiece. In order to achieve adequate interocclusal space, an occlusal reduction of 1-2 mm was executed along with a proximal reduction reaching 1 mm below the gingival margin. A more conservative reduction was applied to the buccal and lingual surfaces. After preparation, any remaining decayed dentin tissue was removed using a steel round bur with a low-speed micromotor. To ensure occlusal harmony, diamond burs were used to perform abrasion on the crown edges, and the trimmed crown edges were polished using rubber aids before cementation.

Cementation

Intervention Type: PROCEDURE

Figaro crowns were placed on the prepared teeth with finger pressure, following the manufacturer's instructions for the luting cement to be used. For each cement, the recommended setting time was observed, and excess cement residues were removed accordingly.

Device: Resin-modified glass-ionomer cement

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.

Group Type: EXPERIMENTAL

Tooth Preperation

Intervention Type: PROCEDURE

After the caries were removed, the teeth were prepared according to the manufacturer's recommendations for Figaro Crowns. Fiberglass crowns (Figaro Crowns Inc., USA) of the most suitable size in terms of the mesio-distal dimension of the tooth were selected. Following the establishment of anesthesia, the teeth were prepared using diamond cutting burs with a high-speed, water-cooled turbine handpiece. In order to achieve adequate interocclusal space, an occlusal reduction of 1-2 mm was executed along with a proximal reduction reaching 1 mm below the gingival margin. A more conservative reduction was applied to the buccal and lingual surfaces. After preparation, any remaining decayed dentin tissue was removed using a steel round bur with a low-speed micromotor. To ensure occlusal harmony, diamond burs were used to perform abrasion on the crown edges, and the trimmed crown edges were polished using rubber aids before cementation.

Cementation

Intervention Type: PROCEDURE

Figaro crowns were placed on the prepared teeth with finger pressure, following the manufacturer's instructions for the luting cement to be used. For each cement, the recommended setting time was observed, and excess cement residues were removed accordingly.

Interventions

Tooth Preperation

After the caries were removed, the teeth were prepared according to the manufacturer's recommendations for Figaro Crowns. Fiberglass crowns (Figaro Crowns Inc., USA) of the most suitable size in terms of the mesio-distal dimension of the tooth were selected. Following the establishment of anesthesia, the teeth were prepared using diamond cutting burs with a high-speed, water-cooled turbine handpiece. In order to achieve adequate interocclusal space, an occlusal reduction of 1-2 mm was executed along with a proximal reduction reaching 1 mm below the gingival margin. A more conservative reduction was applied to the buccal and lingual surfaces. After preparation, any remaining decayed dentin tissue was removed using a steel round bur with a low-speed micromotor. To ensure occlusal harmony, diamond burs were used to perform abrasion on the crown edges, and the trimmed crown edges were polished using rubber aids before cementation.

Intervention Type: PROCEDURE

Cementation

Figaro crowns were placed on the prepared teeth with finger pressure, following the manufacturer's instructions for the luting cement to be used. For each cement, the recommended setting time was observed, and excess cement residues were removed accordingly.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Zulfikar Zahit Ciftci

Head of Principal Dentisty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zulfikar Zahit Ciftci, Phd

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TDH-2020-5280

Identifier Type: -

Identifier Source: org_study_id