Dental Restorations in Children, Pediatric Dentistry
Conditions
Keywords
3D-printed resin crowns, Bioflx crowns, Primary molars, Pulp therapy, Crown survival
Brief summary
This randomized comparative clinical trial will evaluate and compare the clinical performance of preformed three-dimensional (3D)-printed resin crowns and Bioflx crowns in children with pulp-treated primary molars requiring full coronal restoration. The study will use a split-mouth design in which eligible children have two comparable contralateral primary molars treated with the two crown types, with the crown allocation to the right or left tooth determined by a computer-generated random sequence. Crown survival will be the primary outcome. Secondary outcomes will include the modified plaque index, modified gingival index, and occlusal wear. Clinical assessments are planned at one week and at 3, 6, and 12 months after treatment.
Detailed description
This randomized comparative clinical trial will evaluate the clinical performance of preformed three-dimensional (3D)-printed resin crowns compared with Bioflx crowns for the restoration of pulp-treated primary molars in children. The study will use a randomized split-mouth design. Eligible children aged 3-9 years who require pulp therapy and full coronal restoration of at least two comparable contralateral primary molars will receive both crown types. One molar will be restored with a preformed 3D-printed resin crown, and the contralateral molar will be restored with a Bioflx crown. The allocation of crown type to the right or left side will be determined using a computer-generated random sequence. The primary outcome will be crown survival at 12 months, defined as the crown remaining present and functional without requiring replacement. Crown loss or replacement will be considered treatment failure. Secondary outcomes will include the modified plaque index, modified gingival index, and occlusal wear. Clinical assessments are planned at one week and at 3, 6, and 12 months after crown placement. The study will be conducted at the outpatient pediatric dentistry clinic of the Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt. The anticipated enrollment is 18 children, contributing 36 primary molars in total.
Interventions
DEVICEPreformed 3D-Printed Resin Crown
Preformed three-dimensional (3D)-printed resin crowns will be used for full coronal restoration of pulp-treated primary molars in children aged 3-9 years. The clinical performance of these crowns will be evaluated in a randomized split-mouth design, with each participant receiving a 3D-printed resin crown on one primary molar and a Bioflx crown on the contralateral molar. Outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment.
DEVICEBioflx Crown
Bioflx crowns will be used as the comparison intervention for full coronal restoration of pulp-treated primary molars in children aged 3-9 years. In this randomized split-mouth study, each participant will receive a Bioflx crown on one primary molar and a preformed 3D-printed resin crown on the contralateral molar. Outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment.
Sponsors
Faculty of Dental Medicine for Girls
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be unaware of which crown type is placed on each tooth. The outcome assessor will also be blinded to crown allocation during clinical evaluations.
Intervention model description
This study uses a randomized split-mouth design. Each eligible child will receive both interventions on two comparable contralateral primary molars requiring pulp therapy and full coronal coverage. One molar will be restored with a preformed 3D-printed resin crown, and the other with a Bioflx crown. A computer-generated random sequence will determine which crown type is placed on the right or left molar. Clinical outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment.
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
Children of both sexes aged 3-9 years. Systemically healthy children. Children with at least two comparable contralateral primary molars requiring pulp therapy and full coronal coverage. Children with a Frankl behavior rating of definitely positive or positive.
Exclusion criteria
Children with disabilities or systemic diseases. Primary molars with pathological discrepancies in root resorption. Primary molars with furcation inflammation. Children with oral parafunctional habits. Primary molars with root caries. Children with temporomandibular joint disorders. Primary molars expected to undergo physiological exfoliation within 24 months. Children with a Frankl behavior rating of negative or definitely negative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crown Survival | 12 months after crown placement | Crown survival will be evaluated based on whether the crown remains present and functional without requiring replacement. A crown will be considered a failure if it is lost or requires replacement. Survival will be compared between preformed 3D-printed resin crowns and Bioflx crowns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Plaque Index | 1 week and 3, 6, and 12 months after crown placement | Oral plaque accumulation around the crowns will be assessed using the modified plaque index specified in the study protocol. Scores will be compared between the two crown types. |
| Modified Gingival Index | 1 week and 3, 6, and 12 months after crown placement | Gingival health around the restored primary molars will be evaluated using the modified gingival index specified in the study protocol. Scores will be compared between the two crown types. |
| Occlusal Wear | 3, 6, and 12 months after crown placement | Occlusal wear of the crowns will be evaluated clinically according to the assessment method specified in the study protocol. Findings will be compared between preformed 3D-printed resin crowns and Bioflx crowns. |
Contacts
CONTACTSomaya MA Kahwa, Doctor
CONTACTSomaya Kahwa
PRINCIPAL_INVESTIGATORSomaya MA Kahwa, Doctor
Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
Outcome results
None listed