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

Influence of Luting Cement on the Clinical Outcomes of Zirconia Pediatric Crowns. A 3 Year Split-Mouth Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Deep Caries
• Intervention / Treatment: Drug: Bio-active cement; Drug: Packable glass ionomer

Detailed Description

Restoration of pulp treated or badly broken down deciduous teeth with full coverage restoration have shown superior success rate to all other restorative materials.

Restoration of deciduous teeth with esthetic full coverage restoration has been a challenging aim especially for the more functionally loaded posterior teeth. Due to the continuous increase in socio-economic standards; restoring posterior teeth with esthetic restoration is on high demand nowadays.

The recently introduced zirconia pediatric crowns have been very promising in terms of strength and toughness. Clinical trials on maxillary incisors have shown very high success rates in terms of retention and gingival health.

The problem of restoring posterior deciduous teeth with pre-fabricated zirconia crowns is that its retention is only and totally dependent on luting cement, in addition to the problem of the deteriorated gingival condition around crowns in general.

Being recently introduced to the market; there have not been any clinical trials studying retention of zirconia posterior pediatric crowns published yet.

Recently introduced bio-active cement [NuSmile® BioCem™] is claimed by the manufacturer to be the solution of this problem due to the shock absorbing effect, bioactive components, and antimicrobial effect making it tougher than traditional cements and more gingival friendly.

Also, experienced clinicians have found that packable glass ionomer gives very acceptable results for retention of zirconia pediatric crowns. This may be due to the fact that, pre-fabricated pediatric crown is not well adapted to the prepared tooth creating a greater gap between the prepared tooth and the crown, resulting in a greater film thickness of luting cement, which may benefit from the stronger, tougher and less soluble packable glass ionomer rather than the conventional glass ionomer cement for cementation of zirconia crowns.

There is no clear evidence whether it's better to cement zirconia based crowns with conventional or adhesive cement; and to the investigator's knowledge, there is no data available for the best clinical practice in cementation of zirconia pediatric crowns; and so, this study was carried out to compare the effectiveness of bio-active cement with packable glass ionomer when used for cementation of zirconia pediatric crowns.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 4-7 years old patients having two contra-lateral mandibular first primary molars indicated for restoration with crowns.
2. Presence of sound tooth structure at the cervical margins of the teeth.
3. Presence of opposing functioning teeth.
4. Included teeth should be assessed clinically as free from active pulpal or periodontal conditions.
5. Patient must be in general good health, with no medical contraindication to dental treatment.
6. Patient must be available for required recalls as outlined in the protocol.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bio-active cement; 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; A cement used for crown cementation, specially recommended for pediatric esthetic crowns; Other Names: Bio-cem
ACTIVE_COMPARATOR: Packable glass ionomer; 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; Glass ionomer cement with improved mechanical properties usually used for restoration of simple small cavities and in Atraumatic Restorative Treatment; Other Names: Fuji IX; High viscosity glass ionomer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of fractured crowns	Binary outcome (Fractured/not fractured), assessed by examination	1 week, 1, 3, 6, 9, 12, 18, 24 and 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival condition	Ordered categorical, assessed by calculating gingival index (0: no inflammation, 1: mild inflammation, 2: moderate inflammation, 3: severe inflammation)	1 week, 1, 3, 6, 9, 12, 18, 24 and 36 months

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (ACTUAL): June 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Cementation; Zirconia crowns
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: Zirconia crowns cementation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No