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

NCT06558747 | Completed

• 1 other identifier: TDK-2016-1761
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Retention Status

  The clinical success of the crowns regarding the retention status was evaluated as either present or absent based on whether the crown remained on the restored tooth at each follow-up appointment. Crowns that were still in place during the follow-up visit were considered successful in terms of retention, while those that had decemented were considered unsuccessful.

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

Secondary Outcomes (4)

• Pulpal Survival

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

• Plaque Index

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

• Gingival Index

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

• Probing Depth

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

Study Arms (4)

Device: Bioactive Cement

EXPERIMENTAL

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.

Procedure: Tooth Preperation; Procedure: Cementation

Device: Resin Cement

EXPERIMENTAL

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.

Procedure: Tooth Preperation; Procedure: Cementation

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.

Procedure: Tooth Preperation; Procedure: Cementation

Device: Resin-modified glass-ionomer cement

EXPERIMENTAL

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.

Procedure: Tooth Preperation; Procedure: Cementation

Interventions

Tooth Preperation PROCEDURE

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

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

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

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Department of Pediatric Dentistry, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor at Pediatric Dentistry

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 19, 2024
• Study Start: November 20, 2017
• Primary Completion: March 8, 2018
• Study Completion: March 8, 2019
• Last Updated: October 1, 2024

Record last verified: 2024-08

Locations

TU (1)