Decayed Teeth, Carious Lesion
Conditions
Keywords
primary molars, stainless steel crown, zirconia crown, bioflx crown, clinical evaluation
Brief summary
The purpose of this clinical trial was to compare clinically three different crowns for primary molars; stainless steel crown, zirconia crown and Bioflx crown. the main questions it aims to answer are: is Bioflex crown is an alternative to stainless steel crown and zirconia crown? Seventy-five patients their age range between 3 and 8 years participated in this study. The participants are divided into three groups representing group A for stainless steel crown (n=25), group B for zirconia crown (n=25) and group C for Bioflx crown (n=25). Plaque index, crown retentivity and gingival index will be evaluated at evaluated at baseline, 6 and 12 months.
Interventions
DEVICEstainless steel crown
Participants in this arm received a stainless steel crown for primary teeth restoration. The crowns were selected based on the clinical assessment of the patient's dental need.
DEVICEZirconia crown
Participants in this arm received a zirconia crown for primary teeth restoration. The crowns were selected to provide a more aesthetic and durable option compared to stainless steel.
DEVICEBioflx crown
Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.
Sponsors
Delta University for Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This research was designed as a randomized controlled trial conducted by a single operator to minimize operator-induced errors. A total sample of 75 primary molars was determined, allowing for potential dropouts, and was evenly distributed into three groups of 25. Each group recieved different crown, groups A for stianless steel crown, group B for zirconia crown and group C for Bioflx crown. At 6 and 12 months follow up, each crown was evaluated clinically such as plaque index , crown retentivity and gingival index.
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient within the age group of 3-8 years old. * Healthy children free of any systemic disease. * Pulpotomized or pulpectomized (endodontically treated) lower second primary molars. * Patients who have the behavioral rating of definitely positive or positive according to the frankl behaviour.
Exclusion criteria
* • Patient younger than 3 years old or older than 8 years old. * non-Healthy children or have any systemic disease. * primary molars with no pulpal treatment * Patients who have the behavioral rating of definitely negative or negative according to the frankl behaviour.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque accumulation | 6 months and 12 months | Measured using the Löe and Silness index, where each of the four surfaces of the crown (buccal, lingual, mesial, and distal) was scored from 0 to 3 (0 = no plaque, 3 = abundance of soft matter). The scores from the four areas were added and divided by four to obtain the plaque index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| crown retention | 6 months and 12 months | Assessed using the USPHS criteria, where Alpha indicated the crown was continuous with the existing anatomic form, Bravo indicated a missing part of the crown but not enough to expose the underlying dentin/base, and Charlie indicated sufficient loss of crown substance to expose the underlying dentin/base or complete loss of the crown |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gingival health | 6 months and 12 months | Evaluated using the bleeding index according to Löe and Silness (1963), with scores of 0 (no inflammation), 1 (mild inflammation), 2 (moderate inflammation), and 3 (severe inflammation). |
Countries
Egypt
Outcome results
None listed