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Not yet recruiting NCT07648979

3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars.

No phase Interventional Dental Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D printed resin based crowns, Prefabricated stainless steel crowns.
Who it may be relevant to
Registry conditions: Dental Caries. Basic parameters: 4 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Evaluation of 3D Printed Resin Based Crowns Versus Stainless Steel Crowns in Pulpotomized Primary Mandibular Molars : A Randomized Controlled Clinical Trial

Overview

The goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. The main questions it aims to answer are: Do 3D-printed resin-based crowns provide better gingival health than stainless steel crowns? Are there differences in plaque accumulation, crown retention, and child and parent satisfaction between the two crown types? Participants will: Receive either a 3D-printed resin-based crown or a stainless steel crown after pulpotomy. Attend follow-up visits for clinical evaluation over 12 months.

Detailed description

primary mandibular molars will be randomly assigned to receive either 3D-printed resin-based crowns or stainless steel crowns. Following pulp therapy and crown placement, participants will attend follow-up visits over a 12-month period. Clinical evaluation will be performed to assess gingival health, plaque accumulation, crown retention, and child and parent satisfaction, in order to determine whether 3D-printed resin-based crowns can be an effective esthetic alternative to stainless steel crowns.

Interventions

  • Device 3D printed resin based crowns
    1-Select an appropriately sized resin-based prefabricated crown based on the mesio-distal width of the tooth. 2-Perform occlusal reduction of approximately 1.5-2.0 mm following the natural occlusal anatomy. 3-Reduce buccal and lingual cusps, central groove, and marginal ridges to achieve adequate occlusal clearance. 4-Perform proximal reduction using a tapered fissure or diamond bur to eliminate mesial and distal contacts by approximately 1.0 mm. 5-Avoid creating ledges or damaging adjacent teet
  • Device Prefabricated stainless steel crowns
    1-Select an appropriately sized stainless steel crown based on the mesiodistal width of the tooth. 2-Perform minimal occlusal reduction (approximately 1.0-1.5 mm) following the anatomical occlusal contour to create suficient space for crown placement. 3-Lightly reduce proximal contacts to allow crown seating, without creating steps or excessive taper. 4-Perform minimal buccal and lingual reduction only if required to eliminate undercuts and facilitate passive seating. 5-Round sharp line angles a

Primary outcome measures

  • Gingival index [Time frame: baseline, 3 months, 6 months, 9 months, 12 months]
Secondary outcome measures (3)
  • Plaque accumulation [Time frame: baseline, 3 months, 6 months, 9 months, 12 months]
  • Child and parent satisfaction [Time frame: Immediately post operative]
  • Crown retention [Time frame: baseline, 3 months, 6 months, 9 months, 12 months]

Eligibility criteria

Inclusion criteria

Children aged 4 to 8 years. Cooperative children who are able to accept dental treatment. Teeth diagnosed with reversible pulpitis. Children in good general health with no systemic conditions affecting oral health.

Parents/guardians willing to provide written informed consent and attend follow-up visits.

Exclusion criteria

Teeth deemed non-restorable (e.g., gross carious destruction or fractures beyond restoration).

Parents/guardians unwilling to participate in the study or provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of dentistry — Cairo

Publications

  • Flores F, Silva A, Willig R, Reyes A, Serpa J, Marconcin P, Vieira F, Soares D, Casanova N. Exergames as an Effective Alternative to Real Environmental Tennis Training for Adolescents. Sports (Basel). 2024 Jun 17;12(6):168. doi: 10.3390/sports12060168. PMID 38921862

Identifiers

NCT: NCT07648979 · FDCU-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗