Can Zirconia Crown be the First Choice for Primary Teeth?
Primary Purpose
Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dental Crown
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children focused on measuring zirconia, crown, endodontic, pediatric
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Erciyes University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Zirconia crown anterior (NuSmile, Houston, Texas, USA).
Zirconia crown posterior (NuSmile, Houston, Texas, USA).
Stainless steel crown (3M-ESPE, St. Paul, Minnesota, USA)
Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)
Outcomes
Primary Outcome Measures
Visual examination
The incidence of crown retention, gingival index, marginal crown localisation
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)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04574180
First Posted
September 15, 2020
Last Updated
February 20, 2023
Sponsor
TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT04574180
Brief Title
Can Zirconia Crown be the First Choice for Primary Teeth?
Official Title
Can Zirconia Crown be the First Restorative Choice After Endodontic Treatment for Primary Teeth?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
September 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
zirconia, crown, endodontic, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Zirconia crown anterior (NuSmile, Houston, Texas, USA).
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Zirconia crown posterior (NuSmile, Houston, Texas, USA).
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Stainless steel crown (3M-ESPE, St. Paul, Minnesota, USA)
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)
Intervention Type
Other
Intervention Name(s)
Dental Crown
Other Intervention Name(s)
Zirconia Crown (NuSmile, Houston, Texas, USA), Stainless Steel Crown (3M-ESPE, St. Paul, Minnesota, USA), Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)
Intervention Description
Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function.
Primary Outcome Measure Information:
Title
Visual examination
Description
The incidence of crown retention, gingival index, marginal crown localisation
Time Frame
6 months follow up period
Title
Radiographic evaluation
Description
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)
Time Frame
6 months follow up period
Secondary Outcome Measure Information:
Title
Questionaire
Description
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)
Time Frame
6 months follow up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Erciyes University
City
Kayseri̇
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
individual participant data (IPD) that underlie results
Citations:
PubMed Identifier
30343392
Citation
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.
Results Reference
background
PubMed Identifier
31648670
Citation
Seminario 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.
Results Reference
background
PubMed Identifier
32165959
Citation
El 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.
Results Reference
background
PubMed Identifier
29569449
Citation
Sonbol 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.
Results Reference
background
PubMed Identifier
29395008
Citation
Lee 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.
Results Reference
background
Learn more about this trial
Can Zirconia Crown be the First Choice for Primary Teeth?
We'll reach out to this number within 24 hrs