3D-printed Crowns Versus Zirconia Crowns for Primary Molars

NCT06068244 | Completed

• 1 other identifier: PED23-1D
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare between 3D-printed crowns and prefabricated zirconia crowns for restoring pulpally-treated primary molars regarding the following aspects:

1. 1.In vivo:
2. 2.In vitro:

Conditions

Dental Caries in Children

Keywords

"zirconia crowns"; "pulpotomy"; "3 dimension printed crowns"

Outcome Measures

Primary Outcomes (6)

• Gingival health (gingival index)

  Gingival index and plaque index A gingival index, based on the Loe and Silness scoring criteria (1963). It will be measured by gently inserting the tip of a periodontal probe into the sulcus surrounding each tooth. Scoring as followed: 0 = Normal (Absence of inflammation) 1. = Mild gingivitis (slight change in color, slight edema. No bleeding on probing) 2. = Moderate gingivitis (redness, edema and glazing. Bleeding on probing) 3. = Severe gingivitis (marked redness and edema; ulceration; tendency to spontaneous bleeding) * Gingival index and plaque index.

  1 year follow up for vivo part only

• plaque index

  Plaque index (PI) (Silness and Loe) PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically. PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental Plaque index (PI) (Silness and Loe) PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically. PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental

  1year follow up

• Marginal integrity

  by visual inspection and explorer Alfa: Explorer does not catch or has one way catch when drawn across the restoration/tooth interface. Bravo: Explorer falls into crevice when drawn across the restoration/tooth interface, Dentin is not exposed; clinically acceptable. Charlie: Dentin or base is exposed along the margin; clinically unacceptable.

  1yeat follow up

• crown retention

  Alpha: Bonded Bravo: Debonded Charlie: Lost

  one year follow up

• In vitro marginal gap

  micrometers

  Immediately after samples preparation

• in vitro fracture resistance

  newton

  Immediately after samples preparation

Secondary Outcomes (1)

• parent satisfaction

  immediately after cementation of crowns

Study Arms (2)

3D printed crowns

EXPERIMENTAL

Participants received 3D printed resin crowns

Other: 3D printed crowns

Zirconia crowns

ACTIVE COMPARATOR

Participants received ready made zirconia crowns

Other: Zirconia crowns

Interventions

3D printed crowns OTHER

3D printed crowns

3D printed crowns

Zirconia crowns OTHER

Nu smile zirconia crowns

Zirconia crowns

Eligibility Criteria

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

You may qualify if:

• Children included in the study should stratify to the following criteria:
• Age range of children from 4 -7 years.
• Having at least one vital primary molar with deep carious lesion indicated for pulpotomy or pulpectomy.
• The expected exfoliation date of the selected primary teeth must be more than 12 months from the start date of the study.

You may not qualify if:

• a) Uncooperative children who needs sedation or general anesthesia. b) Children with physical, intellectual disability or medical conditions that may complicate treatment.
• c) Teeth with poor prognosis due to the presence of an abscess or a sinus, mobility or advanced bone resorption.
• d) Presence of internal or external root resorption.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

Related Publications (9)

• Hamrah MH, Mokhtari S, Hosseini Z, Khosrozadeh M, Hosseini S, Ghafary ES, Hamrah MH, Narges Tavana. Evaluation of the Clinical, Child, and Parental Satisfaction with Zirconia Crowns in Maxillary Primary Incisors: A Systematic Review. Int J Dent. 2021 Jul 5;2021:7877728. doi: 10.1155/2021/7877728. eCollection 2021.

  PMID: 34285695 BACKGROUND

• Al-Halabi MN, Bshara N, Nassar JA, Comisi JC, Rizk CK. Clinical Performance of Two Types of Primary Molar Indirect Crowns Fabricated by 3D Printer and CAD/CAM for Rehabilitation of Large Carious Primary Molars. Eur J Dent. 2021 Jul;15(3):463-468. doi: 10.1055/s-0040-1721905. Epub 2021 Feb 3.

  PMID: 33535245 BACKGROUND

• Abuelniel G, Eltawil S. Clinical and Radiographic Evaluation of Stainless Steel versus Zirconia Crowns on Primary Molars: Randomized Controlled Trial. Egypt Dent J. 2018;64(2):977-89.

  BACKGROUND

• Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar.

  PMID: 32509626 BACKGROUND

• Ludwig KH, Fontana M, Vinson LA, Platt JA, Dean JA. The success of stainless steel crowns placed with the Hall technique: a retrospective study. J Am Dent Assoc. 2014 Dec;145(12):1248-53. doi: 10.14219/jada.2014.89.

  PMID: 25429038 BACKGROUND

• Attari N, Roberts JF. Restoration of primary teeth with crowns: a systematic review of the literature. Eur Arch Paediatr Dent. 2006 Jun;7(2):58-62; discussion 63. doi: 10.1007/BF03320816.

  PMID: 17140529 BACKGROUND

• Abdulhadi B, Abdullah M, Alaki S, Alamoudi N, Attar M. Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth. J Pediatr Dent. 2017;5(1):21.

  BACKGROUND

• Ashima G, Sarabjot KB, Gauba K, Mittal HC. Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. J Clin Pediatr Dent. 2014 Fall;39(1):18-22. doi: 10.17796/jcpd.39.1.t6725r5566u4330g.

  PMID: 25631720 BACKGROUND

• Schweiger J, Edelhoff D, Guth JF. 3D Printing in Digital Prosthetic Dentistry: An Overview of Recent Developments in Additive Manufacturing. J Clin Med. 2021 May 7;10(9):2010. doi: 10.3390/jcm10092010.

  PMID: 34067212 BACKGROUND

Study Officials

• Geham Gaber allam

  Assistant professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at pediatric dentistry and dental public health department

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 5, 2023
• Study Start: July 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)