Influence of Luting Cement on the Clinical Outcomes of Zirconia Pediatric Crowns

NCT03993431 | Completed

• 1 other identifier: Zirconia crowns cementation
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this split-mouth study was to compare the efficacy of using Bio-active cement versus Packable glass ionomer for cementation of posterior zirconia pediatric crowns.

Conditions

Deep Caries

Keywords

Cementation; Zirconia crowns

Outcome Measures

Primary Outcomes (9)

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  1 week

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  1 month

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  3 months

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  6 months

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  9 months

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  12 months

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  18 months

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  24 months

• Number of debonded crowns

  Binary outcome (debonded/not debonded), assessed by examination

  36 months

Secondary Outcomes (1)

• Number of fractured crowns

  1 week, 1, 3, 6, 9, 12, 18, 24 and 36 months

Other Outcomes (1)

• Gingival condition

  1 week, 1, 3, 6, 9, 12, 18, 24 and 36 months

Study Arms (2)

Bio-active cement

EXPERIMENTAL

Bio-active cement dispensed into the crown, and the crown was properly positioned over the tooth, cement was allowed to self-set for 20 seconds while maintaining gentle pressure on the crown, then flash cured using a light curing unit to remove excess cement, buccal and lingual surfaces were light cured for extra 10 seconds each.

Drug: Bio-active cement

Packable glass ionomer

ACTIVE COMPARATOR

Dentin conditioner was applied to the prepared crown surfaces for 20 sec, then rinsed, and dried. Capsule was activated, mixed for 10 seconds in an amalgamator, then loaded into the capsule applier to extrude cement directly into the crown, the crown was properly positioned over the tooth, cement was allowed to self-set for 2 minutes while maintaining gentle pressure on the crown, excess cement was removed before complete setting of cement.

Drug: Packable glass ionomer

Interventions

Bio-active cement DRUG

A cement used for crown cementation, specially recommended for pediatric esthetic crowns

Also known as: Bio-cem

Bio-active cement

Packable glass ionomer DRUG

Glass ionomer cement with improved mechanical properties usually used for restoration of simple small cavities and in Atraumatic Restorative Treatment

Also known as: Fuji IX, High viscosity glass ionomer

Packable glass ionomer

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old patients having two contra-lateral mandibular first primary molars indicated for restoration with crowns.
• Presence of sound tooth structure at the cervical margins of the teeth.
• Presence of opposing functioning teeth.
• Included teeth should be assessed clinically as free from active pulpal or periodontal conditions.
• Patient must be in general good health, with no medical contraindication to dental treatment.
• Patient must be available for required recalls as outlined in the protocol.

You may not qualify if:

• Teeth with defects like hypoplasia or hypocalcification.
• Patients with untreated periodontal disease.
• Patients with any pathological or systemic problems that would not allow the dental procedures in this study to take place.
• Teeth that exhibit mobility.
• Patients that show signs of severe bruxism or teeth clenching.
• Subjects with deleterious oral habits like pencil/pen chewing.
• Uncooperative patients.

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Interventions

fuji IX

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric Dentistry, Faculty of Dentistry, Fayoum University

Model Details: split mouth

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: July 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share