3D-printed Endocrowns Versus Prefabricated Zirconia Crowns in Pulpally-treated Primary Molars

NCT04909827 | Completed Phase 4

• 1 other identifier: PED 20-6D
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study : to compare between 3D printed microfilled hybrid composite endocrowns and prefabricated zirconia crowns for restoring pulpally treated primary molars regarding the following aspects: In Vivo aspects Patient satisfaction \*The esthetic, functional and biological performance according to FDI clinical criteria. At 3, 6 and 12 months In Vitro aspects:

• Marginal gap.
• Fracture resistance. Study methodology: This study is a combined randomized clinical trial and in vitro study .The study will be conducted at the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University as follows: In vivo comparison of the clinical performance of 3D printed Endocrowns versus prefabricated zirconia crowns regarding esthetic, functional and biological performance according to FDI clinical criteria. In vitro evaluation of the marginal gap and fracture resistance of both types of restorations.

Conditions

Pulpotomy; Tooth Restoration

Keywords

3D-printing; Endocrown; zirconia crown

Outcome Measures

Primary Outcomes (1)

• clinical performance

  Federation Dentaire international clinical assessment scale. Minimum value is 1 and highest value is 11. Higher values mean worst outcome.

  6 months

Secondary Outcomes (1)

• patient satisfaction

  6 months

Study Arms (2)

group A

EXPERIMENTAL

3D printed microfilled hybrid composite Endocrowns

Procedure: 3D-printed endocrown

group B

EXPERIMENTAL

prefabricated zirconia crowns

Procedure: Zirconia crown

Interventions

3D-printed endocrown PROCEDURE

pulpotomy and restoration with 3D-printed microfilled hybrid composite endocrown

group A

Zirconia crown PROCEDURE

pulpotomy and restoration with prefabricated zirconia crown

group B

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Having at least one vital primary molar with deep carious lesion indicated for pulpotomy or pulpectomy.
• The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.

You may not qualify if:

• Children who are uncooperative needing sedatin or general anasthesia.
• Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
• e) Teeth of poor prognosis due to th e presence of an abscess or a sinus, mobility, advanced bone or root resorption.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Abbasya, 4576, Egypt

Location

Related Publications (1)

• Abbas LH, Wassel MO, Hassan IT, El-Dimeery AG, Elghazawy RK. 3D printed endocrowns versus prefabricated zirconia crowns for pulpotomized primary molars: A randomized controlled trial. J Dent. 2025 Feb;153:105556. doi: 10.1016/j.jdent.2025.105556. Epub 2025 Jan 6.

  PMID: 39778737 DERIVED

Study Officials

• Mariem O Wassel, PhD

  Ainshams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: A total of thirty primary mandibular molars in healthy subjects will be selected. The molars will be randomly assigned equally into two treatment groups 1. Group A: 3D printed microfilled hybrid composite Endocrowns 2. Group B: pr efabricated zirconia crowns Pulpotomy

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 2, 2021
• Study Start: September 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)