Primary TeethNCT03740308
Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth
A study testing Locally Made Zirconia Crowns and ZR Zirconia Crwons NuSmile ® Crowns in people with Primary Teeth, run by Damascus University at 1 site in Syria.
Trial summary
This randomized clinical trial aims to compare the clinical outcomes of two full-coronal-coverage restorations (locally-made preformed Zirconia crowns [LMP] and NuSmile Zirconia crowns [Nu/ZR]) in treating carious primary teeth. Read more about this study
- Who is it for?
- Ages 5 to 5 years
- Conditions the study is for
- Primary Teeth
- What is being tested?
- Locally Made Zirconia Crowns and ZR Zirconia Crwons NuSmile ® Crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- 17 May 2018to 1 Aug 2019
- 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 5 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients within the age group of 4 to 8 years of age.
- Patients with good oral hygiene.
- Healthy children, i.e. free of any systematic diseases or any developmental disturbances of the teeth and jaws
- A minimal of two surfaces of caries in the targeted tooth
- Corresponding treated teeth has not got any crown earlier
- Patients with ECC as defined by the American Academy for Pediatric Dentistry.
- Cooperative patients who have a dental behavioral assessment of "definitely positive" according to Frankl behavior classification scale.
Who cannot join
- No patient is excluded by gender, race, or due to socio-economic backgrounds.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized clinical trial aims to compare the clinical outcomes of two full-coronal-coverage restorations (locally-made preformed Zirconia crowns [LMP] and NuSmile Zirconia crowns [Nu/ZR]) in treating carious primary teeth. Amongst the children attending the clinics of the Dental School at Damascus University, the ones having an indication for crowns restorations will be screened and if they are conformant to the inclusion criteria then they will be recruited until 60 teeth are reached (30 teeth for LMP/ZR restorations and 30 for Nu/ZR restorations).
Read the detailed description
This randomized clinical trial compares the clinical outcomes of using two full-coronal zirconia restorations (locally-made preformed zirconia crowns, and NuSmile zirconia crowns) in treating carious primary teeth. Children attending to the clinics of the Faculty of Dentistry - Damascus University and who happen to be in need for dental restorations will be screened for the study's inclusion criteria till 60 teeth are recruited (30 teeth for locally made preformed zirconia crowns restorations and 30 for NuSmile zirconia crowns restorations). One crown only will be used for each patient (totally 60 patients) to ensure equalizing the variables for both groups. The randomization will be done using SPSS software version 20.0 (Armonk, NY; IBM Corp., USA). The study is going to be a double-blinded study (Patients blinding and Outcomes-assessor blinding). Simple descriptive statistics will be used for the analysis, also using Wilcoxon Signed-Rank test. The level of significance will be set at (α = 0.05) and the level of confidence at (95%). The intervention is preparing primary molars which have one or more indications for crowning, and according to manufacturer instructions. Then following up the treated primary molars for 1 month, 3 months, and 6 months intervals. The main goals are measuring and comparing the status of the gingiva and any improvements in the gingival health relative to the intervention, the plaque retention in regard to the gingival response to the material of restoration, and also the crowns resistance to changes, despite its high cost.
- Conditions
- Primary Teeth
- Being tested
- Locally Made Zirconia Crowns, ZR Zirconia Crwons NuSmile ® Crowns
- Keywords
- Primary posterior teeth, zirconia crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locally Made Zirconia CrownsDevice
Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. Locally Made Zirconia Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).
ZR Zirconia Crwons NuSmile ® CrownsDevice
Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. ZR Zirconia Crwons NuSmile ® Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).
| Study group | Role | What they receive |
|---|---|---|
| Locally Made Zirconia Crowns | Active comparator | One operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions. Receives: Device: Locally Made Zirconia Crowns |
| ZR Zirconia Crwons NuSmile ® Crowns | Experimental | One operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions. (Same as Arm 1 Description) Receives: Device: ZR Zirconia Crwons NuSmile ® Crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of crowns integrity
Crowns integrity changes will be measured with the naked eye and the light cure device. The scores are as follows: (0 = No crack, No fracture, No chip) (1 = Chip) (2 = Crack) (3 = Fracture). (Cvar and Rygp 2005)
Measured: Evaluating after 1 month, 3 months, 6 months
Secondary outcomes (2)
Changes of gingival index
is measured by passing the periodontal probe tip gently within the sulcus around each crowned tooth. The scores are as follows: (0 = normal gingiva) (1= mild inflammation) (2 = Moderate inflammation) (3 = severe inflammation). (Loe and Silness 1963)
Measured: Evaluating after 1 month, 3 months, 6 months
Changes of crown marginal adaptation
Crown marginal adaptation will be measured at the buccal and lingual walls and will be referred to as either good for crowns with sealed margins or poor when the explorer detects an open margin. (Farsi and Sharaf 2004)
Measured: Evaluating after 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start17 May 2018
- Primary completion1 Dec 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Primary TeethStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed AlTinawi, PhD., Study director, Professor - Pediatric Dentistry Department - Faculty of Dentistry - Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740308
- Sponsor's protocol ID
- UDDS-Pedo-01-2018
- Status last verified
- Jan 2020
- First submitted
- 24 Aug 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual participant data will be only available for the researchers in the department of Pedodontics, Damascus University
Publications
Aiem E, Smail-Faugeron V, Muller-Bolla M. Aesthetic preformed paediatric crowns: systematic review. Int J Paediatr Dent. 2017 Jul;27(4):273-282. doi: 10.1111/ipd.12260. Epub 2016 Aug 17.
PubMed 27532506Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
PubMed 16315023Fuks AB, Ram D, Eidelman E. Clinical performance of esthetic posterior crowns in primary molars: a pilot study. Pediatr Dent. 1999 Nov-Dec;21(7):445-8.
PubMed 10633519Sharaf AA, Farsi NM. A clinical and radiographic evaluation of stainless steel crowns for primary molars. J Dent. 2004 Jan;32(1):27-33. doi: 10.1016/s0300-5712(03)00136-2.
PubMed 14659715Mittal HC, Goyal A, Gauba K, Kapur A. Clinical Performance of Indirect Composite Onlays as Esthetic Alternative to Stainless Steel Crowns for Rehabilitation of a Large Carious Primary Molar. J Clin Pediatr Dent. 2016;40(5):345-52. doi: 10.17796/1053-4628-40.5.345.
PubMed 27617373Croll TP, Helpin ML. Preformed resin-veneered stainless steel crowns for restoration of primary incisors. Quintessence Int. 1996 May;27(5):309-13.
PubMed 8941812Shah PV, Lee JY, Wright JT. Clinical success and parental satisfaction with anterior preveneered primary stainless steel crowns. Pediatr Dent. 2004 Sep-Oct;26(5):391-5.
PubMed 15460292
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth
- ClinicalTrials.gov ID
- NCT03740308
- Acronym / sponsor ID
- UDDS-Pedo-01-2018
- Conditions
- Primary Teeth
- Keywords
- Primary posterior teeth, zirconia crown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 14 Nov 2018 (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 randomized clinical trial aims to compare the clinical outcomes of two full-coronal-coverage restorations (locally-made preformed Zirconia crowns [LMP] and NuSmile Zirconia crowns [Nu/ZR]) in treating carious primary teeth. Amongst the children attending the clinics of the Dental School at Damascus University, the ones having an indication for crowns restorations will be screened and if they are conformant to the inclusion criteria then they will be recruited until 60 teeth are reached (30 teeth for LMP/ZR restorations and 30 for Nu/ZR restorations).
Detailed description
This randomized clinical trial compares the clinical outcomes of using two full-coronal zirconia restorations (locally-made preformed zirconia crowns, and NuSmile zirconia crowns) in treating carious primary teeth. Children attending to the clinics of the Faculty of Dentistry - Damascus University and who happen to be in need for dental restorations will be screened for the study's inclusion criteria till 60 teeth are recruited (30 teeth for locally made preformed zirconia crowns restorations and 30 for NuSmile zirconia crowns restorations). One crown only will be used for each patient (totally 60 patients) to ensure equalizing the variables for both groups. The randomization will be done using SPSS software version 20.0 (Armonk, NY; IBM Corp., USA). The study is going to be a double-blinded study (Patients blinding and Outcomes-assessor blinding). Simple descriptive statistics will be used for the analysis, also using Wilcoxon Signed-Rank test. The level of significance will be set at (α = 0.05) and the level of confidence at (95%). The intervention is preparing primary molars which have one or more indications for crowning, and according to manufacturer instructions. Then following up the treated primary molars for 1 month, 3 months, and 6 months intervals. The main goals are measuring and comparing the status of the gingiva and any improvements in the gingival health relative to the intervention, the plaque retention in regard to the gingival response to the material of restoration, and also the crowns resistance to changes, despite its high cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locally Made Zirconia Crowns | Active comparator | Device: Locally Made Zirconia CrownsOne operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions. |
| ZR Zirconia Crwons NuSmile ® Crowns | Experimental | Device: ZR Zirconia Crwons NuSmile ® CrownsOne operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions. (Same as Arm 1 Description) |
Who may qualify
- Ages
- 5 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients within the age group of 4 to 8 years of age.
- Patients with good oral hygiene.
- Healthy children, i.e. free of any systematic diseases or any developmental disturbances of the teeth and jaws
- A minimal of two surfaces of caries in the targeted tooth
- Corresponding treated teeth has not got any crown earlier
Key exclusion criteria (1 listed)
- No patient is excluded by gender, race, or due to socio-economic backgrounds.
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 |
|---|---|---|
| Locally Made Zirconia CrownsOcclusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. Locally Made Zirconia Crowns are fixed using Glass Ionomer cement (Fuji- Jaban). | Device | Locally Made Zirconia Crowns |
| ZR Zirconia Crwons NuSmile ® CrownsOcclusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. ZR Zirconia Crwons NuSmile ® Crowns are fixed using Glass Ionomer cement (Fuji- Jaban). | Device | ZR Zirconia Crwons NuSmile ® Crowns |
Primary outcome
Changes of crowns integrity
Time frame: Evaluating after 1 month, 3 months, 6 months
Crowns integrity changes will be measured with the naked eye and the light cure device. The scores are as follows: (0 = No crack, No fracture, No chip) (1 = Chip) (2 = Crack) (3 = Fracture). (Cvar and Rygp 2005)
2 secondary outcomes
Changes of gingival index
Time frame: Evaluating after 1 month, 3 months, 6 months
Changes of crown marginal adaptation
Time frame: Evaluating after 1 month, 3 months, 6 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 5 Feb 2020.
- Results publication: PubMed 27532506Aiem E, Smail-Faugeron V, Muller-Bolla M. Aesthetic preformed paediatric crowns: systematic review. Int J Paediatr Dent. 2017 Jul;27(4):273-282. doi: 10.1111/ipd.12260. Epub 2016 Aug 17.
- Results publication: PubMed 16315023Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
- Results publication: PubMed 10633519Fuks AB, Ram D, Eidelman E. Clinical performance of esthetic posterior crowns in primary molars: a pilot study. Pediatr Dent. 1999 Nov-Dec;21(7):445-8.
- Results publication: PubMed 14659715Sharaf AA, Farsi NM. A clinical and radiographic evaluation of stainless steel crowns for primary molars. J Dent. 2004 Jan;32(1):27-33. doi: 10.1016/s0300-5712(03)00136-2.
- Results publication: PubMed 27617373Mittal HC, Goyal A, Gauba K, Kapur A. Clinical Performance of Indirect Composite Onlays as Esthetic Alternative to Stainless Steel Crowns for Rehabilitation of a Large Carious Primary Molar. J Clin Pediatr Dent. 2016;40(5):345-52. doi: 10.17796/1053-4628-40.5.345.
- Results publication: PubMed 8941812Croll TP, Helpin ML. Preformed resin-veneered stainless steel crowns for restoration of primary incisors. Quintessence Int. 1996 May;27(5):309-13.
- Results publication: PubMed 15460292Shah PV, Lee JY, Wright JT. Clinical success and parental satisfaction with anterior preveneered primary stainless steel crowns. Pediatr Dent. 2004 Sep-Oct;26(5):391-5.
- Individual participant dataSharing planned: No. The Individual participant data will be only available for the researchers in the department of Pedodontics, Damascus University
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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.
Mohamed AlTinawi, PhD. study director
Professor - Pediatric Dentistry Department - Faculty of Dentistry - Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locally Made Zirconia Crowns and ZR Zirconia Crwons NuSmile ® Crowns in people with Primary Teeth, run by Damascus University at 1 site in Syria.
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 7 inclusion and 1 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 Feb 2020. 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 Syria. 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?
Changes of crowns integrity (time frame: Evaluating after 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740308, which also lists 7 linked publications.
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 Feb 2020.