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

NCT07648979 | Not Yet Recruiting

• 1 other identifier: FDCU-2026-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

Dental caries; 3D-Printed Resin Crowns; Primary Molars; Pulpotomy; Stainless Steel Crowns; crown retention; Gingival Health

Outcome Measures

Primary Outcomes (1)

• Gingival index

  The GI was measured by passing an explorer tip gently within the sulcus mesial, distal, buccal, and lingual surface of each crowned molar. it was scored on a scale of 0 to 3 0= no bleeding 1. only one bleeding point appearing someseconds after probing 2. bleeding points appearing immediately after probing 3. profuse bleeding appearing immediately after probing spreading towards the marginal gingiva

  baseline, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (3)

• Plaque accumulation

  baseline, 3 months, 6 months, 9 months, 12 months

• Child and parent satisfaction

  Immediately post operative

• Crown retention

  baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

3D printed resin crowns

EXPERIMENTAL

Children will receive indirect restorations using 3D-printed resin crowns on primary molars affected by reversible pulpitis

Device: 3D printed resin based crowns

Stainless steel crowns

ACTIVE COMPARATOR

Children will receive stainless steel crowns on primary molars affected by reversible pulpitis

Device: Prefabricated stainless steel crowns

Interventions

3D printed resin based crowns DEVICE

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 teeth during proximal reduction. 6-Slightly reduce buccal and lingual surfaces to eliminate undercuts and facilitate crown seating. 7-Round and smooth all sharp line angles and points of the preparation. 8-In cases with adjacent teeth, perform additional interproximal reduction if required for proper seating.9-Try-in the crown intraorally and seat it using firm pressure from lingual to buccal direction. 10-Check marginal adaptation, ensuring slight subgingival extension (approximately 0.5-1.0 mm).

3D printed resin crowns

Prefabricated stainless steel crowns DEVICE

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 and smooth rough surfaces to allow proper adaptation. 5-Verify adequate occlusal clearance and passive path of insertion. 6-Try-in the crown and adjustsize if necessary to ensure proper fit. 7-Trim and contour crown margins to achieve optimal gingival adaptation (if needed). 8-Seat the crown firmly using finger pressure to confirm complete seating. 9-Cement the crown with glass ionomer cement and remove excess cement after initial setting.

Stainless steel crowns

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry

Cairo, Egypt

Location

Related Publications (1)

• 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 BACKGROUND

Related Links

• Official ClinicalTrials.gov website providing information about clinical trial registration and study records.
• regarding 3D-printed resin-based dental restorative materials used in this study

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sherine Badr, PHD

  Cairo University

  STUDY CHAIR

• Nariman Osama, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hanna Abdel Moneim, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Nariman Osama, BDS

CONTACT

01010381531; Nareman.osama@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Principal Investigator (Resident in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.)

Model Details: Participants will be randomly assigned to one of two parallel groups. One group will receive 3D-printed resin-based crowns, while the other group will receive stainless steel crowns following pulpotomy of primary mandibular molars.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)