Clinical trial NCT03889535: Anterior Zirconia vs. Resin Strip Crowns
Official title: A Comparison of Anterior Pediatric Zirconia Crowns and Bonded Composite Resin Strip Crowns: A One-year Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries, Dental
Keywords: primary maxillary incisors
crowns
bonded composite resin strip crowns
zirconia crowns
one-year survival
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: To assess the clinical outcome of pediatric zirconia crowns and to provide evidence-based treatment, a prospective, well controlled study would be beneficial. Due to a lack of existing outcome data for bonded resin strip crowns and zirconia crowns, a feasibility study is indicated to establish the basis for randomized controlled trial design. The goal of this feasibility study is to compare the clinical outcomes of the zirconia crowns and bonded composite resin strip crowns in primary maxillary incisors. Therefore the aims of the research study is as follows:

1. To statistically compare the one-year survival of resin composite strip crowns and zirconia crowns in primary maxillary incisors.
2. To statistically compare the frequency of pulp therapy required for placement of zirconia crowns and resin composite strip crowns in primary maxillary incisors.
3. To measure the frequency at which teeth randomized to zirconia crowns are deemed restorable with strip crowns and not zirconia crowns, and vice versa.

After induction of general anesthesia, following the confirmation that incisor(s) can be restored by the treating dentist, each study participant will be randomly allocated to either the strip crown or the zirconia crown group. The assignment will be done using a computer-generated simple random number sequence with a one to one allocation ratio. The treatment will be consistent for each patient for all eligible teeth, although the experimental unit is the incisor.

Each research participant will be reassessed clinically at 6 and 12 months after treatment. Follow-up appointments will be scheduled by the Department of Dentistry at the Hospital for Sick Children (SickKids). Clinical reassessment will be conducted by one investigator. Intra-oral photographs will be acquired at 6 months and at 12 months. All photographs will be taken by the same investigator, using a standardized imaging format. Two photographs per patient will be acquired: one extra-oral photograph, limited to the maxillary right cuspid (tooth 53) to left cuspid (tooth 63); and one extra-oral maxillary occlusal photograph, limited to the maxillary right cuspid (tooth 53) to left cuspid (tooth 63). Photographs will be taken with a Canon Rebel XSi and a Canon ring flash Macro Ring Lite MR-14EX II.

Parents will also take 2 photographs of their child's teeth using their own camera or phone. They will be provided with an example of how to take those photographs. They will send the photographs to the investigators via a secured SickKids e-mail. Only the research investigators and the research coordinator will have access to the secured e-mail. Pictures sent by the parents will be stored on a the photograph and X-ray database at SickKids. A reminder to take the pictures at 6 and 12 months after the surgery will be sent using the secured e-mail. Photographs taken by the parents will be used for the photographic assessment if clinical photographs are unsuccessful at the follow-ups and if they are of sufficient quality for assessment based on the investigators' judgment.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patient is classified as American Society of Anesthesiologists (ASA) III or higher
2. Caries associated with signs and symptoms of irreversible pulpitis and/or clinical evidence of an odontogenic infection
3. 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
4. Patient has non-English speaking parents.

Primary outcomes:
measure: Survival outcome
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of pulp therapy
timeFrame: 1 day (Day of crown restoration)
measure: Treatment plan alteration
timeFrame: 1 day (Day of crown restoration)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Michael Joseph Casas
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Michael J Casas, DDS
role: PRINCIPAL_INVESTIGATOR
References: