Dental Caries in Children
Conditions
Keywords
digital crowns, zirconia crowns, primary teeth
Brief summary
Badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. For the intervention group, teeth will be prepared to receive the digital crown after intraoral scanning while for the control group, teeth will be prepared to receive the prefabricated zirconia crowns. Teeth will be followed up clinically for 1 year, at 1, 6 and 12 months.
Detailed description
This is a 12-month randomized, controlled, two parallel arms clinical trial. Patients aging from 4 to 10 years with multi-surface decay will be selected. After caries removal and pulp exposure, pulpotomy or partial pulpectomy technique will be performed,then the teeth will be randomized to the interventional group of digital crowns or to the control group of prefabricated zirconia crowns. For preparation of digital crowns, the occlusal reduction was done by 1.5-2 mm. The proximal contacts will be broken and the entire clinical crown structure was reduced by 0.8-1.0 mm , followed by a a subgingival finish line . For the scanning procedure, the upper and lower arches will be scanned with intra oral scanner, and making sure every point is well detailed . A third scan of the occlusal bite is then performed in order to establish the patient's occlusion. For the milling procedure, Brilliant Crios composite the blocks will be used and milled with the CEREC MC X milling unit . The inner surface of the crown will be sandblasted with Al2O3 . For zirconia crown preparation, occlusal reduction of 1.5-2mm will be performed by a football diamond bur. The occlusal third of the buccal and lingual surfaces will be also reduced . The whole crown will be reduced by 0.8-1.0 mm by means of a tapered diamond stone .A shoulder finish line will be created. The try in crown will be tested, then the shoulder finish line will be removed and the preparation will be extended subgingivally to feather-edge. The crowns will then be cemented with the self-adhesive resin cement (Solocem, Coltene, Whaledent, Altstatten, Switzerland) .Light curing was performed while applying pressure on the crown and then waiting for 5 minutes for complete cementing
Interventions
PROCEDUREDigital crowns
crowns fabricated digitally by CAD-CAM technology
PROCEDUREzirconia crowns
crowns that are ready made for primary teeth
Sponsors
National Research Centre, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
participants will not be informed of which crown they will receive
Intervention model description
a randomized clinical trial with two parallel arms
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Patients within the age group of 4-10years. Badly decayed or multi-surface affected primary teeth Healthy children free of any systemic disease Patients with cooperative behavior rating definitely positive or positive on the Frank rating scale
Exclusion criteria
* Teeth with developmental disturbances * Teeth with poor prognosis as signs of necrosis, extensive pathological root resorption * patients with parafunctional habits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and parent satisfaction | 1, 6 and 12 months | 5-point Likert scale for patient and parent satisfaction.(1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention of the crowns | 1, 6 and 12 months | It will be recorded by clinical examination as a binary outcome; Yes: if crown is retentive & No: if crown is unretentive |
| Gingival inflammation | 1, 6 and 12 months | It was measured by gently inserting the tip of a periodontal probe into the sulcus surrounding each crowned tooth. Scoring as follows: 0 = Normal (Absence of inflammation) 1. = Mild gingivitis (slight change in color, slight edema. No bleeding on probing) 2. = Moderate gingivitis (redness, edema and glazing. Bleeding on probing) 3. = Severe gingivitis (marked redness and edema; ulceration;tendency to spontaneous bleeding |
| Color match | 1, 6 and 12 months | The color match will be recorded in natural light with the patient in the upright position for 5 to 10 seconds. No noticeable difference from adjacent teeth, Slight shade mismatch , Obvious shade mismatch and will be recorded digitally by vita easy shade |
| Opposing tooth wear | 1, 6 and 12 month | The wear of opposing teeth for the crowns placed will be measured by Smith and Knight Index and it will be measured digitally by a software |
Countries
Egypt
Outcome results
None listed