An interventional study of Preformed 3D-Printed Resin Crown and Bioflx Crown in Dental Restorations in Children and Pediatric Dentistry, sponsored by Faculty of Dental Medicine for Girls. Not yet recruiting. Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment
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.
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.
Faculty of Dental Medicine for Girls is the lead sponsor of 54 studies on the registry; 6 are open to participants now.
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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.
Preformed 3D-printed resin crowns will be used to restore pulp-treated primary molars requiring full coronal coverage. In this randomized split-mouth study, each participant will receive this crown on one of two comparable contralateral primary molars. The side receiving this crown will be determined by a computer-generated random sequence.
Device: Preformed 3D-Printed Resin Crown
Bioflx crowns will be used to restore pulp-treated primary molars requiring full coronal coverage. In this randomized split-mouth study, each participant will receive this crown on the contralateral primary molar. The side receiving this crown will be determined by a computer-generated random sequence.
Device: Bioflx 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.
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.
Crown Survival
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.
Time frame: 12 months after crown placement
Modified Plaque Index
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.
Time frame: 1 week and 3, 6, and 12 months after crown placement
Modified Gingival Index
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.
Time frame: 1 week and 3, 6, and 12 months after crown placement
Occlusal Wear
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.
Time frame: 3, 6, and 12 months after crown placement
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Faculty of Dental Medicine for Girls