Dental Caries in ChildrenNCT04574180
Can Zirconia Crown be the First Choice for Primary Teeth?
A study testing Dental Crown in people with Dental Caries in Children, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Objective: Early loss of primary teeth due to caries, can cause occlusion disorders, aesthetic problems, nutritional problems, abnormal language habits, speech disorders and psychological problems temporary or permanent. Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Dental Crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 9 Sep 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 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients without systemic disease The American Society of Anesthesiologists (ASA)1-2,
- Patients under 10 years old to perform endodontic treatment for adequate root support
- Clinical and radiographically confirmed dental caries scored international caries detection and assessment system(icdas) criteria 4-5.
- Patient/parent approve
Who cannot join
- Patients with systemic and mental diseases
- Acute abscess or mobility
- Internal or external resorption
- Inadequate oral hygiene after oral health motivation that contraindicate root canal treatment
- Need for endocarditis prophylaxis
- Temporomandibular joint(TMJ) disorders, bruxism
- Absence of antagonistic teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Zirconia Crown be the First Restorative Choice After Endodontic Treatment for Primary Teeth?
Objective: Early loss of primary teeth due to caries, can cause occlusion disorders, aesthetic problems, nutritional problems, abnormal language habits, speech disorders and psychological problems temporary or permanent. The purpose of this study was to evaluate the success of using prefabricated aesthetic crowns for the restoration of excessive tooth loss.
Study design: In this randomized, non-blinded clinical study a total of 45 teeth were included, primary molars and anterior teeth and requiring restoration after root canal treatment. Stainless steel(SCC), zirconia(ZC) and strip(S) crowns compared clinically, radiographically and periodontally during follow up period for 6 months. Parents were asked to fill out questionnaire at the 1st and 6th months to evaluate the satisfaction level. In addition, patients' pain and discomfort level was assessed using the visual analogue scale (VAS) scale.
Read the detailed description
The color of crowns made it impossible to blind during clinical assessment. Thus, this study was a non-blinded, randomised, and prospective clinical trial.
Sample size: This study included 20 maxillary anterior and 25 posterior teeth that required restoration due to excessive material loss. The study groups were:
Zirconia crown(ZC) restoration on the primary central and lateral tooth with root canal treatment (n = 10), strip crown(S) restoration on the primary central and lateral tooth with root canal treatment (n = 10), Zirconia crown(ZC) restoration on primary teeth with root canal treatment (n = 12), Stainless-steel crown(SSC) restoration on primary teeth with root canal treatment (n = 13).
Clinical Procedure:
Assessment
Clinical assesment: Table 1 Gingival scores: Löe and Silness Gingival Index(GI)[Löe, 1967].
Periapical radiographic evaluation: Preoperative and every follow up visit. (Radiographic assesment: Table 2)
Intraoral photos (standard method): before treatment, after treatment and at every follow-up visit.
Crown restoration: All caries were removed after administration of local anaesthesia and proper isolation. Calcium hydroxide/iodoform paste (Vitapex®) pulpectomy was performed according to the guideline. Teeth were restored with a composite resin Nova Resin (IMICRYL®, Konya, Turkey) and glass ionomer cement (MERON®, Voco, Germany) was used as a base material. Strip Crown Forms (3M-ESPE, St. Paul,Minnesota, USA) were used to restore teeth group SC. ZC group (NuSmile, Houston, Tex. the USA) and SCC(3M ESPE, Minnesota, USA) used.
Visual analogue scale(VAS): 0-2: no pain/discomfort 4-6:moderate 8-10: high pain/discomfort.
The child was asked to choose his/her feelings about the tooth after the procedure and in follow-up appointments. Parents were asked to complete their satisfaction surveys, including the post-op and 6-month controls for patient satisfaction assessment.
Statistical Method:
IBM® SPSS® Statistics V23 analysed data. The Mann-Whitney U and Chi-square tests were used for intergroup comparisons within the anterior and posterior regions. The Friedman and Cochrane Q tests were used for intra-group time-wise comparisons. Analysis results were presented as the median (q1-q3) and frequency (percentage). P<0.05 was considered statistically significant.
Table 1: Clinical assesment
Crown retention 0= yes 1= no
Individual modified gingival index 0= healthy 1= mild gingival bleeding with a papillus 2= severe inflammation
Plaque index 0= no plaque
- = presence of plaque as a film in the gingival margin
- = presence of moderate plaque
- = plaque covering a large number of surfaces
Color change 0 = no coloring
- = minor coloration
- = noticeable coloration
Buccal strip crown surface 0 = no loss 1 = less than 50% loss 2 = more than 50% loss 4 = loss of the entire surface
Surface abrasion of the antagonist teeth 0= no abrasion
- abrasion started on the incisal surface of the casps
- abrasion more than on the casps
Position of the crowns regarding gingival margin 0= subgingival
1= supragingival
Occlusion 0= contact (marked or superficial) 1= no contact
Condition of the antagonistic tooth 0= natural tooth
- restored tooth
- stainless steel crown
- aesthetic crowns
Location on the arch curve 0= normal alignment
- with rotation
- wrong position
Proximal contacts 0= good (floss passing)
1= weak, no contact
Table 2. Postoperative Radiographic Evaluation Criteria and Scores Radiographic evaluation of crown margins 0=good adaptation, continuity in crown contractions
- small radiolucent area under the restoration
- huge openings
- loss of restoration
Radiographic evaluation 0= healthy, no pathology
- presence of a pathology that does not require immediate treatment
- presence of pathology requiring immediate treatment
Radiographic evaluation of pulpal treatment 0=appropriate root treatment
- short or overflowed root treatment
- failed pulpal treatment
- tooth with no pulpal treatment
- Conditions
- Dental Caries in Children
- Being tested
- Dental Crown
- Keywords
- zirconia, crown, endodontic, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental CrownOther
Also called Zirconia Crown (NuSmile, Houston, Texas, USA), Stainless Steel Crown (3M-ESPE, St. Paul, Minnesota, USA), Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)
Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Zirconia crown anterior (NuSmile, Houston, Texas, USA). Receives: Other: Dental Crown |
| Group 2 | Active comparator | Zirconia crown posterior (NuSmile, Houston, Texas, USA). Receives: Other: Dental Crown |
| Group 3 | Active comparator | Stainless steel crown (3M-ESPE, St. Paul, Minnesota, USA) Receives: Other: Dental Crown |
| Group 4 | Active comparator | Strip Crown (3M-ESPE, St. Paul, Minnesota, USA) Receives: Other: Dental Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual examination
The incidence of crown retention, gingival index, marginal crown localisation
Measured: 6 months follow up period
Radiographic evaluation
Periapical film: the rate of radiolucency. According to the index, each tooth was categorized as having a normal periapical structure (score 1), small changes in bone structure (score 2), changes in bone structure with some mineral loss (score 3), periodontitis with well-defined radiolucent areas (score 4), or severe apical periodontitis with exacerbating features (score 5)
Measured: 6 months follow up period
Secondary outcomes (1)
Questionaire
A Visual Analogue Scale (VAS): no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: 6 months follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2017
- Primary completion9 Mar 2018
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Aslı GÜÇLÜ, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574180
- Sponsor's protocol ID
- TSA-2017-6723
- Status last verified
- Feb 2023
- First submitted
- 15 Sep 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) that underlie results
Publications
Walia T, Brigi C, KhirAllah ARMM. Comparative evaluation of surface roughness of posterior primary zirconia crowns. Eur Arch Paediatr Dent. 2019 Feb;20(1):33-40. doi: 10.1007/s40368-018-0382-4. Epub 2018 Oct 20.
PubMed 30343392Seminario AL, Garcia M, Spiekerman C, Rajanbabu P, Donly KJ, Harbert P. Survival of Zirconia Crowns in Primary Maxillary Incisors at 12-, 24- and 36-Month Follow-Up. Pediatr Dent. 2019 Sep 15;41(5):385-390.
PubMed 31648670El Makawi Y, Khattab N. In Vitro Comparative Analysis of Fracture Resistance of Lithium Disilicate Endocrown and Prefabricated Zirconium Crown in Pulpotomized Primary Molars. Open Access Maced J Med Sci. 2019 Dec 13;7(23):4094-4100. doi: 10.3889/oamjms.2019.864. eCollection 2019 Dec 15.
PubMed 32165959Sonbol HN, Al-Bitar ZB, Shraideh AZ, Al-Omiri MK. Parental-caregiver perception of child oral-health related quality of life following zirconia crown placement and non-restoration of carious primary anterior teeth. Eur J Paediatr Dent. 2018 Mar;19(1):21-28. doi: 10.23804/ejpd.2018.19.01.04.
PubMed 29569449Lee JH. Guided tooth preparation for a pediatric zirconia crown. J Am Dent Assoc. 2018 Mar;149(3):202-208.e2. doi: 10.1016/j.adaj.2017.08.048. Epub 2018 Feb 1.
PubMed 29395008
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Zirconia Crown be the First Restorative Choice After Endodontic Treatment for Primary Teeth?
- ClinicalTrials.gov ID
- NCT04574180
- Acronym / sponsor ID
- TSA-2017-6723
- Conditions
- Dental Caries in Children
- Keywords
- zirconia, crown, endodontic, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 5 Oct 2020 (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.
Objective: Early loss of primary teeth due to caries, can cause occlusion disorders, aesthetic problems, nutritional problems, abnormal language habits, speech disorders and psychological problems temporary or permanent. The purpose of this study was to evaluate the success of using prefabricated aesthetic crowns for the restoration of excessive tooth loss.
Study design: In this randomized, non-blinded clinical study a total of 45 teeth were included, primary molars and anterior teeth and requiring restoration after root canal treatment. Stainless steel(SCC), zirconia(ZC) and strip(S) crowns compared clinically, radiographically and periodontally during follow up period for 6 months. Parents were asked to fill out questionnaire at the 1st and 6th months to evaluate the satisfaction level. In addition, patients' pain and discomfort level was assessed using the visual analogue scale (VAS) scale.
Detailed description
The color of crowns made it impossible to blind during clinical assessment. Thus, this study was a non-blinded, randomised, and prospective clinical trial.
Sample size: This study included 20 maxillary anterior and 25 posterior teeth that required restoration due to excessive material loss. The study groups were:
Zirconia crown(ZC) restoration on the primary central and lateral tooth with root canal treatment (n = 10), strip crown(S) restoration on the primary central and lateral tooth with root canal treatment (n = 10), Zirconia crown(ZC) restoration on primary teeth with root canal treatment (n = 12), Stainless-steel crown(SSC) restoration on primary teeth with root canal treatment (n = 13).
Clinical Procedure:
Assessment
Clinical assesment: Table 1 Gingival scores: Löe and Silness Gingival Index(GI)[Löe, 1967].
Periapical radiographic evaluation: Preoperative and every follow up visit. (Radiographic assesment: Table 2)
Intraoral photos (standard method): before treatment, after treatment and at every follow-up visit.
Crown restoration: All caries were removed after administration of local anaesthesia and proper isolation. Calcium hydroxide/iodoform paste (Vitapex®) pulpectomy was performed according to the guideline. Teeth were restored with a composite resin Nova Resin (IMICRYL®, Konya, Turkey) and glass ionomer cement (MERON®, Voco, Germany) was used as a base material. Strip Crown Forms (3M-ESPE, St. Paul,Minnesota, USA) were used to restore teeth group SC. ZC group (NuSmile, Houston, Tex. the USA) and SCC(3M ESPE, Minnesota, USA) used.
Visual analogue scale(VAS): 0-2: no pain/discomfort 4-6:moderate 8-10: high pain/discomfort.
The child was asked to choose his/her feelings about the tooth after the procedure and in follow-up appointments. Parents were asked to complete their satisfaction surveys, including the post-op and 6-month controls for patient satisfaction assessment.
Statistical Method:
IBM® SPSS® Statistics V23 analysed data. The Mann-Whitney U and Chi-square tests were used for intergroup comparisons within the anterior and posterior regions. The Friedman and Cochrane Q tests were used for intra-group time-wise comparisons. Analysis results were presented as the median (q1-q3) and frequency (percentage). P<0.05 was considered statistically significant.
Table 1: Clinical assesment
Crown retention 0= yes 1= no
Individual modified gingival index 0= healthy 1= mild gingival bleeding with a papillus 2= severe inflammation
Plaque index 0= no plaque
- = presence of plaque as a film in the gingival margin
- = presence of moderate plaque
- = plaque covering a large number of surfaces
Color change 0 = no coloring
- = minor coloration
- = noticeable coloration
Buccal strip crown surface 0 = no loss 1 = less than 50% loss 2 = more than 50% loss 4 = loss of the entire surface
Surface abrasion of the antagonist teeth 0= no abrasion
- abrasion started on the incisal surface of the casps
- abrasion more than on the casps
Position of the crowns regarding gingival margin 0= subgingival
1= supragingival
Occlusion 0= contact (marked or superficial) 1= no contact
Condition of the antagonistic tooth 0= natural tooth
- restored tooth
- stainless steel crown
- aesthetic crowns
Location on the arch curve 0= normal alignment
- with rotation
- wrong position
Proximal contacts 0= good (floss passing)
1= weak, no contact
Table 2. Postoperative Radiographic Evaluation Criteria and Scores Radiographic evaluation of crown margins 0=good adaptation, continuity in crown contractions
- small radiolucent area under the restoration
- huge openings
- loss of restoration
Radiographic evaluation 0= healthy, no pathology
- presence of a pathology that does not require immediate treatment
- presence of pathology requiring immediate treatment
Radiographic evaluation of pulpal treatment 0=appropriate root treatment
- short or overflowed root treatment
- failed pulpal treatment
- tooth with no pulpal treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Dental CrownZirconia crown anterior (NuSmile, Houston, Texas, USA). |
| Group 2 | Active comparator | Other: Dental CrownZirconia crown posterior (NuSmile, Houston, Texas, USA). |
| Group 3 | Active comparator | Other: Dental CrownStainless steel crown (3M-ESPE, St. Paul, Minnesota, USA) |
| Group 4 | Active comparator | Other: Dental CrownStrip Crown (3M-ESPE, St. Paul, Minnesota, USA) |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients without systemic disease The American Society of Anesthesiologists (ASA)1-2,
- Patients under 10 years old to perform endodontic treatment for adequate root support
- Clinical and radiographically confirmed dental caries scored international caries detection and assessment system(icdas) criteria 4-5.
- Patient/parent approve
Key exclusion criteria (7 listed)
- Patients with systemic and mental diseases
- Acute abscess or mobility
- Internal or external resorption
- Inadequate oral hygiene after oral health motivation that contraindicate root canal treatment
- Need for endocarditis prophylaxis
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 |
|---|---|---|
| Dental CrownAlso: Zirconia Crown (NuSmile, Houston, Texas, USA), Stainless Steel Crown (3M-ESPE, St. Paul, Minnesota, USA), Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Visual examination
Time frame: 6 months follow up period
The incidence of crown retention, gingival index, marginal crown localisation
Radiographic evaluation
Time frame: 6 months follow up period
Periapical film: the rate of radiolucency. According to the index, each tooth was categorized as having a normal periapical structure (score 1), small changes in bone structure (score 2), changes in bone structure with some mineral loss (score 3), periodontitis with well-defined radiolucent areas (score 4), or severe apical periodontitis with exacerbating features (score 5)
1 secondary outcome
Questionaire
Time frame: 6 months follow up period
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 21 Feb 2023.
- Background: PubMed 30343392Walia T, Brigi C, KhirAllah ARMM. Comparative evaluation of surface roughness of posterior primary zirconia crowns. Eur Arch Paediatr Dent. 2019 Feb;20(1):33-40. doi: 10.1007/s40368-018-0382-4. Epub 2018 Oct 20.
- Background: PubMed 31648670Seminario AL, Garcia M, Spiekerman C, Rajanbabu P, Donly KJ, Harbert P. Survival of Zirconia Crowns in Primary Maxillary Incisors at 12-, 24- and 36-Month Follow-Up. Pediatr Dent. 2019 Sep 15;41(5):385-390.
- Background: PubMed 32165959El Makawi Y, Khattab N. In Vitro Comparative Analysis of Fracture Resistance of Lithium Disilicate Endocrown and Prefabricated Zirconium Crown in Pulpotomized Primary Molars. Open Access Maced J Med Sci. 2019 Dec 13;7(23):4094-4100. doi: 10.3889/oamjms.2019.864. eCollection 2019 Dec 15.
- Background: PubMed 29569449Sonbol HN, Al-Bitar ZB, Shraideh AZ, Al-Omiri MK. Parental-caregiver perception of child oral-health related quality of life following zirconia crown placement and non-restoration of carious primary anterior teeth. Eur J Paediatr Dent. 2018 Mar;19(1):21-28. doi: 10.23804/ejpd.2018.19.01.04.
- Background: PubMed 29395008Lee JH. Guided tooth preparation for a pediatric zirconia crown. J Am Dent Assoc. 2018 Mar;149(3):202-208.e2. doi: 10.1016/j.adaj.2017.08.048. Epub 2018 Feb 1.
- Individual participant dataSharing planned: No. individual participant data (IPD) that underlie results
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Crown in people with Dental Caries in Children, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 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 21 Feb 2023. 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 Turkey (Türkiye). 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?
Visual examination (time frame: 6 months follow up period). The study lists 2 primary outcomes in all. 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 NCT04574180, which also lists 5 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 21 Feb 2023.