Comparison of the Clinical Success of Pediatric Zirconia Crowns Applied with Different Luting Cements

NCT ID: NCT06558747

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-20
• Study Completion Date: 2019-03-08

Brief Summary

This randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (PZCs) for primary molars cemented with different luting cements. The main questions to answer are:

Will there be any difference in the clinical success regarding retention among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding periodontal health among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding pulpal survival among the PZCs cemented with different luting cements? Fifty-three children (60 teeth), between 5 and 11 years old enrolled for the study. Researchers will compare the retention status, plaque index (PI), gingival index (GI), and probing depth (PD) scores, and endodontic/periodontal pathology of PZCs.

Participants will:

• visit the clinic 1st,3rd,6th,12th months after the restoration.

Conditions

Dental Caries; Dental Plaque; Dental Caries in Children

Study Design

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

Study Groups

Device: Bioactive Cement

BioCem™ (NuSmile, Texas, USA) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth. Crowns were stabilized for 20 seconds before applying halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) to the buccal and lingual/palatal surfaces for three seconds each.

Group Type: EXPERIMENTAL

Tooth Preperation

Intervention Type: PROCEDURE

After the caries were removed, the teeth were prepared by shaving according to the manufacturer's recommendations for NuSmile ZR.

Cementation

Intervention Type: PROCEDURE

Pediatric zirconia 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 Cement

The inner surface of the crowns was treated with 'G-Multi Primer' using a brush and subsequently air-dried. The surfaces of the prepared teeth were treated with 37% orthophosphoric acid. The tooth surfaces were rinsed with an air-water spray to remove the acid from the surfaces. After the etching process, the 'G-Premio Bond' was applied to the teeth surfaces with a brush, rubbed for 10 seconds, and then air-dried for five seconds. Then the teeth were exposed to halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) for 10 seconds. G-CEM Linkforce (GC, USA) resin cement was gently applied to crowns, and then crowns were pressed onto the prepared teeth with finger pressure.

Group Type: EXPERIMENTAL

Tooth Preperation

Intervention Type: PROCEDURE

After the caries were removed, the teeth were prepared by shaving according to the manufacturer's recommendations for NuSmile ZR.

Cementation

Intervention Type: PROCEDURE

Pediatric zirconia 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

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.

Group Type: EXPERIMENTAL

Tooth Preperation

Intervention Type: PROCEDURE

After the caries were removed, the teeth were prepared by shaving according to the manufacturer's recommendations for NuSmile ZR.

Cementation

Intervention Type: PROCEDURE

Pediatric zirconia 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

The cement was placed into the crown with the self-mixing syringe, ensuring no air voids were created. The crowns were then seated onto the teeth with finger pressure.

Group Type: EXPERIMENTAL

Tooth Preperation

Intervention Type: PROCEDURE

After the caries were removed, the teeth were prepared by shaving according to the manufacturer's recommendations for NuSmile ZR.

Cementation

Intervention Type: PROCEDURE

Pediatric zirconia 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 by shaving according to the manufacturer's recommendations for NuSmile ZR.

Intervention Type: PROCEDURE

Cementation

Pediatric zirconia 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

Patients:

• no history of allergies
• a Frankl scale score of 3 or 4
• has at least one carious primary molar

Teeth:

• No percussion or palpation sensitivity
• No pathological root resorption
• No abscess and/or fistula
• No radiolucency at the furcation area
• No prior pulpal treatment
• Presence of permanent successor
• No mobility or periodontal disease
• Normal position of permanent successor
• An interproximal decay and/or extensive decay with at least 2 surfaces
• If present, physiological root resorption no more than one-third of the root
• Opposing teeth in occlusal contact
• Normal lamina dura and periodontal space

Exclusion Criteria

• congenital and/or developmental defects
• history of bruxism
• skeletal and/or dental malocclusion
• history of trauma
• infraocclusion

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Hüseyin Karayılmaz

Proffessor at Pediatric Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Pediatric Dentistry, Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TDK-2016-1761

Identifier Type: -

Identifier Source: org_study_id