Deep CariesNCT03993431
Influence of Luting Cement on the Clinical Outcomes of Zirconia Pediatric Crowns
A study testing Bio-active cement and Packable glass ionomer in people with Deep Caries, run by Fayoum University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Bio-active cement and Packable glass ionomer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2018
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-7 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Deep Caries
- Being tested
- Bio-active cement, Packable glass ionomer
- Keywords
- Cementation, Zirconia crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-active cementDrug
Also called Bio-cem
A cement used for crown cementation, specially recommended for pediatric esthetic crowns
Packable glass ionomerDrug
Also called Fuji IX, High viscosity glass ionomer
Glass ionomer cement with improved mechanical properties usually used for restoration of simple small cavities and in Atraumatic Restorative Treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Packable glass ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 1 week
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 1 month
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 3 months
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 6 months
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 9 months
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 12 months
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 18 months
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 24 months
Number of debonded crowns
Binary outcome (debonded/not debonded), assessed by examination
Measured: 36 months
Secondary outcomes (1)
Number of fractured crowns
Binary outcome (Fractured/not fractured), assessed by examination
Measured: 1 week, 1, 3, 6, 9, 12, 18, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study startJul 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe 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
- Model description
- split mouth
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Moussa Azab, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993431
- Sponsor's protocol ID
- Zirconia crowns cementation
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Luting Cement on the Clinical Outcomes of Zirconia Pediatric Crowns. A 3 Year Split-Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03993431
- Acronym / sponsor ID
- Zirconia crowns cementation
- Conditions
- Deep Caries
- Keywords
- Cementation, Zirconia crowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Jun 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- split mouth
| Arm | Type | Receives |
|---|---|---|
| Bio-active cement | Experimental | Drug: Bio-active cementBio-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. |
| Packable glass ionomer | Active comparator | Drug: Packable glass ionomerDentin 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 4-7 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Bio-active cementAlso: Bio-cemA cement used for crown cementation, specially recommended for pediatric esthetic crowns | Drug | Bio-active cement |
| Packable glass ionomerAlso: Fuji IX, High viscosity glass ionomerGlass ionomer cement with improved mechanical properties usually used for restoration of simple small cavities and in Atraumatic Restorative Treatment | Drug | Packable glass ionomer |
Primary outcome
Number of debonded crowns
Time frame: 1 week
Binary outcome (debonded/not debonded), assessed by examination
Number of debonded crowns
Time frame: 1 month
Binary outcome (debonded/not debonded), assessed by examination
Number of debonded crowns
Time frame: 3 months
Binary outcome (debonded/not debonded), assessed by examination
Number of debonded crowns
Time frame: 6 months
Binary outcome (debonded/not debonded), assessed by examination
Number of debonded crowns
Time frame: 9 months
Binary outcome (debonded/not debonded), assessed by examination
Number of debonded crowns
Time frame: 12 months
Binary outcome (debonded/not debonded), assessed by examination
Number of debonded crowns
Time frame: 18 months
Binary outcome (debonded/not debonded), assessed by examination
Number of debonded crowns
Time frame: 24 months
Binary outcome (debonded/not debonded), assessed by examination
Number of debonded crowns
Time frame: 36 months
Binary outcome (debonded/not debonded), assessed by examination
1 secondary outcome
Number of fractured crowns
Time frame: 1 week, 1, 3, 6, 9, 12, 18, 24 and 36 months
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 20 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-active cement and Packable glass ionomer in people with Deep Caries, run by Fayoum University.
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 6 inclusion and 7 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 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of debonded crowns (time frame: 1 week). The study lists 9 primary outcomes in all. 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 20 Jun 2019.