Caries, DentalNCT03889535
Anterior Zirconia vs. Resin Strip Crowns
A study testing Resin strip crowns and Zirconia crowns in people with Caries, Dental, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 months
- Conditions the study is for
- Caries, Dental
- What is being tested?
- Resin strip crowns and Zirconia crowns
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Anterior Pediatric Zirconia Crowns and Bonded Composite Resin Strip Crowns: A One-year Feasibility Study
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.
Read the 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:
- To statistically compare the one-year survival of resin composite strip crowns and zirconia crowns in primary maxillary incisors.
- To statistically compare the frequency of pulp therapy required for placement of zirconia crowns and resin composite strip crowns in primary maxillary incisors.
- 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.
- Conditions
- Caries, Dental
- Being tested
- Resin strip crowns, Zirconia crowns
- Keywords
- primary maxillary incisors, crowns, bonded composite resin strip crowns, zirconia crowns, one-year survival
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin strip crownsDevice
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
Zirconia crownsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Resin strip crowns | Active comparator | Current standard full coverage restoration provided for primary incisors. Please see intervention section for detailed description of technique. Receives: 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. Receives: Device: Zirconia crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Frequency of pulp therapy
On the day of treatment under general anesthesia, the treating dentist, the dental assistant or the nurse will fill out the pulpotomy data collection form. Each treated tooth will be marked as having received a pulpotomy (P), or not having received a pulpotomy (X).
Measured: 1 day (Day of crown restoration)
Treatment plan alteration
On the day of treatment under general anesthesia, the treating dentist, the dental assistant or the nurse will fill out the restorative treatment data collection form. Each form will be filled with the randomly assigned treatment and the completed treatment: zirconia crowns (ZC) or composite resin strip crowns (CRSC). It will be determined if patient received the treatment originally assigned and reason for deviation from randomly selected treatment.
Measured: 1 day (Day of crown restoration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start11 Apr 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Casas, The Hospital for Sick Children
- Investigators
- Michael J Casas, DDS, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889535
- Sponsor's protocol ID
- 1000062660
- Status last verified
- May 2022
- First submitted
- 21 Mar 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient Data (IPD) will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Anterior Pediatric Zirconia Crowns and Bonded Composite Resin Strip Crowns: A One-year Feasibility Study
- ClinicalTrials.gov ID
- NCT03889535
- Acronym / sponsor ID
- 1000062660
- Conditions
- Caries, Dental
- Keywords
- primary maxillary incisors, crowns, bonded composite resin strip crowns, zirconia crowns, one-year survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To statistically compare the one-year survival of resin composite strip crowns and zirconia crowns in primary maxillary incisors.
- To statistically compare the frequency of pulp therapy required for placement of zirconia crowns and resin composite strip crowns in primary maxillary incisors.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin strip crowns | Active comparator | Device: Resin strip crownsCurrent standard full coverage restoration provided for primary incisors. Please see intervention section for detailed description of technique. |
| Zirconia crowns | Experimental | Device: Zirconia crownsExperimental treatment under study. Zirconia crowns are an alternative restorative option. Please see intervention section for detailed description of technique. |
Who may qualify
- Ages
- 18 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resin strip crownsTechnique: 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 | Device | Resin strip crowns |
| Zirconia crownsI.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 | Device | Zirconia crowns |
Primary outcome
Survival outcome
Time frame: 12 months
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.
2 secondary outcomes
Frequency of pulp therapy
Time frame: 1 day (Day of crown restoration)
Treatment plan alteration
Time frame: 1 day (Day of crown restoration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No. Individual Patient Data (IPD) will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Casas, DDS principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin strip crowns and Zirconia crowns in people with Caries, Dental, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.