Anterior Zirconia vs. Resin Strip Crowns

NCT03889535 | Completed

• 1 other identifier: 1000062660
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study is comparing the effectiveness of two different dental crown fillings (resin crowns and zirconia crowns) for primary front teeth (incisors). Both dental crown fillings are currently used by community pediatric dentists. Resin crowns are currently the standard treatment for primary incisors at The Hospital for Sick Children (SickKids). Zirconia crowns are not presently used at SickKids. It is unknown if one type of crown is better than the other type. If the zirconia crowns produce similar or better results in fixing the primary front teeth, then the zirconia crowns may become the new standard of care at SickKids.

Conditions

Caries, Dental

Keywords

primary maxillary incisors; crowns; bonded composite resin strip crowns; zirconia crowns; one-year survival

Outcome Measures

Primary Outcomes (1)

• Survival outcome

  The survival outcome will consist of clinical assessment and photographic assessment. One investigator will clinically assess the incisors for restoration survival. The assessed criteria are: presence of the tooth (teeth lost prior to general anesthesia or during general anesthesia will be excluded from statistical analysis), presence of the restoration, integrity of the restoration, recurrent decay and discoloration. Two blinded disinterested expert raters (staff pediatric dentists) will assess the photographs for restoration survival.

  12 months

Secondary Outcomes (2)

• Frequency of pulp therapy

  1 day (Day of crown restoration)

• Treatment plan alteration

  1 day (Day of crown restoration)

Study Arms (2)

Resin strip crowns

ACTIVE COMPARATOR

Current standard full coverage restoration provided for primary incisors. Please see intervention section for detailed description of technique.

Device: Resin strip crowns

Zirconia crowns

EXPERIMENTAL

Experimental treatment under study. Zirconia crowns are an alternative restorative option. Please see intervention section for detailed description of technique.

Device: Zirconia crowns

Interventions

Resin strip crowns DEVICE

Technique: I.Select shade of resin-based composite II.Rubber dam isolation III.Select primary incisor celluloid crown form with mesiodistal width similar to the tooth to be restored and trim the selected crown form to fit. IV.Remove decay with slow speed round bur. Perform pulp therapy, if indicated. V.Reduce incisal edge by 1.5 mm VI.Reduce interproximal surfaces by 0.5 to 1.0 mm with feather edge at gingival margin. The interproximal walls should be approximately parallel. VII.Reduce buccal surface by 1.0 mm and lingual surface by 0.5 mm with feather edge at gingival margins. VIII. Round line angles IX.Etch for 15 to 20 seconds, rinse and air dry X. Apply bond and polymerise XI. Fill crown form to 2/3 full with composite resin and seat onto the tooth. Remove excess material with hand instrument. Polymerise. XII. Remove celluloid crown form with scaler XIII. Finish and polish

Resin strip crowns

Zirconia crowns DEVICE

I.Choose appropriately sized crown based on tooth's dimension; evaluate occlusion. II.Rubber dam isolation. III.Remove decay, perform pulp therapy if indicated. IV.Prep mesial half of incisal edge to complete thickness of 001 donut bur. V.Prep and blend distal half of incisal edge to create uniform incisal reduction. VI. Create chamfer margin at gum line at least half the thickness of bur tip. VII. Taper incisal half lingually to create a thin incisal edge. VIII. Remove cingulum and 0.75-1.25mm of lingual enamel; blend together forming smooth, slightly concave surface extending to tissue. IX. Thin incisal half. X.With 004 flame bur, remove chamfer margin at tissue level. Keep bur parallel to long axis of tooth. Remove chamfer in incremental steps, XI. Extend tip of bur full 2mm subgingivally. While hugging bur axially along root surface, make 3 circumferential passes. XII.Clean tooth and control bleeding. XIII.Cement crown with pure glass ionomer cement

Zirconia crowns

Eligibility Criteria

• Age: 18 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Incisors with large carious lesions not restorable with intra-coronal restorations
• Incisors that have received pulp therapy
• Incisors that have been fractured and have lost an appreciable amount of tooth structure
• Incisors with multiple hypoplastic defects or developmental disturbances
• Incisors with small interproximal lesions with large areas of cervical decalcification

You may not qualify if:

• Patient is classified as American Society of Anesthesiologists (ASA) III or higher
• Caries associated with signs and symptoms of irreversible pulpitis and/or clinical evidence of an odontogenic infection
• There is radiographic evidence of pathological root resorption, root fracture secondary to trauma or periapical radiolucency, iv) lacking adequate dental coronal structure to allow restoration with full coverage restoration
• Patient has non-English speaking parents.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Michael Joseph Casas

Toronto, Ontario, M9A 4E6, Canada

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Michael J Casas, DDS

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist-in-Chief

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 26, 2019
• Study Start: April 11, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)