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

Akdeniz University

Status: Completed

Conditions: Dental Plaque; Dental Caries; Dental Caries in Children

Treatments: Procedure: Tooth Preperation; Procedure: Cementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06558747

TDK-2016-1761

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

53 participants in 4 patient groups

Device: Bioactive Cement

Experimental group

Description:

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.

Treatment:

Procedure: Cementation

Procedure: Tooth Preperation

Device: Resin Cement

Experimental group

Description:

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.

Treatment:

Procedure: Cementation

Procedure: Tooth Preperation

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.

Treatment:

Procedure: Cementation

Procedure: Tooth Preperation

Device: Resin-modified glass-ionomer cement

Experimental group

Description:

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.

Treatment:

Procedure: Cementation

Procedure: Tooth Preperation