Pediatric Fiberglass Crown in Primary Teeth

NCT06558734 | Completed

• 1 other identifier: TDH-2020-5280
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

Fiberglass crown; Glass-ionomer cement; Resin-modified glass-ionomer cement; Primary molar teeth

Outcome Measures

Primary Outcomes (1)

• Crown success

  Crown success was categorized as "successful" if no loss or fractures occurred and "unsuccessful" otherwise. Failed cases are classified as decementation, occlusal wear and fracture. Fracture classification includes large loss and chipped cases.

  Evaluations were conducted at the 1st, 3rd, 6th, 12th months.

Secondary Outcomes (2)

• Plaque Index

  Evaluations were conducted at the 1st, 3rd, 6th, 12th months.

• Gingival Index

  Evaluations were conducted at the 1st, 3rd, 6th, 12th months.

Other Outcomes (1)

• Parental Satisfaction with fiberglass crown restorations

  Evaluations were conducted at the 1st, 3rd, 6th, 12th months.

Study Arms (2)

Device: Glass-ionomer cement

EXPERIMENTAL

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.

Procedure: Tooth Preperation; Procedure: Cementation

Device: Resin-modified glass-ionomer cement

EXPERIMENTAL

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.

Procedure: Tooth Preperation; Procedure: Cementation

Interventions

Tooth Preperation 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.

Device: Glass-ionomer cement; Device: Resin-modified glass-ionomer cement

Cementation 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: Glass-ionomer cement; Device: Resin-modified glass-ionomer cement

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• did not attend their follow-up appointments

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries; Dental Plaque

Interventions

Cementation

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Deposits

Intervention Hierarchy (Ancestors)

Investigative Techniques; Dental Bonding; Dentistry

Study Officials

• Zulfikar Zahit Ciftci, Phd

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The treatments and evaluations were conducted by different researchers. As a result, masking could be performed for both the investigators and the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Principal Dentisty

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: June 15, 2020
• Primary Completion: November 20, 2021
• Study Completion: November 23, 2022
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

TU (1)