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NOT YET RECRUITING
NCT07902570
NA

3D-Printed Resin Crowns Versus Bioflx Crowns in Primary Molars

Sponsor: Faculty of Dental Medicine for Girls

View on ClinicalTrials.gov

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.

Official title: Clinical Performance of Preformed 3D-Printed Resin Crowns Versus Bioflx Crowns Following Pulp Therapy of Primary Molars

Key Details

Gender

All

Age Range

3 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-11-01

Completion Date

2028-03

Last Updated

2026-10-29

Healthy Volunteers

Yes

Interventions

DEVICE

Preformed 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.

DEVICE

Bioflx 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.