Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars

NCT06706167 | Completed DMC

• 1 other identifier: DU0240721024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial was to compare clinically three different crowns for primary molars; stainless steel crown, zirconia crown and Bioflx crown. the main questions it aims to answer are: is Bioflex crown is an alternative to stainless steel crown and zirconia crown? Seventy-five patients their age range between 3 and 8 years participated in this study. The participants are divided into three groups representing group A for stainless steel crown (n=25), group B for zirconia crown (n=25) and group C for Bioflx crown (n=25). Plaque index, crown retentivity and gingival index will be evaluated at evaluated at baseline, 6 and 12 months.

Conditions

Decayed Teeth; Carious Lesion

Keywords

primary molars; stainless steel crown; zirconia crown; bioflx crown; clinical evaluation

Outcome Measures

Primary Outcomes (1)

• Plaque accumulation

  Measured using the Löe and Silness index, where each of the four surfaces of the crown (buccal, lingual, mesial, and distal) was scored from 0 to 3 (0 = no plaque, 3 = abundance of soft matter). The scores from the four areas were added and divided by four to obtain the plaque index

  6 months and 12 months

Secondary Outcomes (1)

• crown retention

  6 months and 12 months

Other Outcomes (1)

• Gingival health

  6 months and 12 months

Study Arms (3)

stainless steel crown

ACTIVE COMPARATOR

Participants in this arm will receive stainless steel crowns for primary teeth.

Device: stainless steel crown; Device: Zirconia crown; Device: Bioflx crown

zirconia crown

EXPERIMENTAL

Participants in this arm will receive zirconia crowns for primary teeth.

Device: stainless steel crown; Device: Zirconia crown; Device: Bioflx crown

Bioflx crown

EXPERIMENTAL

Participants in this arm will receive Bioflex crowns for primary teeth.

Device: stainless steel crown; Device: Zirconia crown; Device: Bioflx crown

Interventions

stainless steel crown DEVICE

Participants in this arm received a stainless steel crown for primary teeth restoration. The crowns were selected based on the clinical assessment of the patient's dental need.

Bioflx crown; stainless steel crown; zirconia crown

Zirconia crown DEVICE

Participants in this arm received a zirconia crown for primary teeth restoration. The crowns were selected to provide a more aesthetic and durable option compared to stainless steel.

Bioflx crown; stainless steel crown; zirconia crown

Bioflx crown DEVICE

Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.

Bioflx crown; stainless steel crown; zirconia crown

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient within the age group of 3-8 years old.
• Healthy children free of any systemic disease.
• Pulpotomized or pulpectomized (endodontically treated) lower second primary molars.
• Patients who have the behavioral rating of definitely positive or positive according to the frankl behaviour.

You may not qualify if:

• Patient younger than 3 years old or older than 8 years old.
• non-Healthy children or have any systemic disease.
• primary molars with no pulpal treatment
• Patients who have the behavioral rating of definitely negative or negative according to the frankl behaviour.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Delta University For Science and Technology

Gamasa, El Dakhleia, 11152, Egypt

Location

Related Publications (11)

• 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 RESULT

• Uhlen MM, Tseveenjav B, Wuollet E, Furuholm J, Ansteinsson V, Mulic A, Valen H. Stainless-steel crowns in children: Norwegian and Finnish dentists' knowledge, practice and challenges. BMC Oral Health. 2021 Apr 12;21(1):190. doi: 10.1186/s12903-021-01556-6.

  PMID: 33845821 RESULT

• Schuler IM, Hiller M, Roloff T, Kuhnisch J, Heinrich-Weltzien R. Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study. J Dent. 2014 Nov;42(11):1396-403. doi: 10.1016/j.jdent.2014.06.009. Epub 2014 Jun 30.

  PMID: 24994618 RESULT

• Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60.

  PMID: 25905656 RESULT

• Dimitrov E, Georgieva M, Andreeva RJM. Indications for use of performed crowns in pediatric dentistry. 2016;2:439-45.

  RESULT

• Katz CR, de Andrade Mdo R, Lira SS, Ramos Vieira EL, Heimer MV. The concepts of minimally invasive dentistry and its impact on clinical practice: a survey with a group of Brazilian professionals. Int Dent J. 2013 Apr;63(2):85-90. doi: 10.1111/idj.12018. Epub 2013 Mar 12.

  PMID: 23550521 RESULT

• Aggarwal P, Goyel V, Mathur S, Sachdev V. Effect of Stainless-Steel Crown and Preformed Zirconia Crown on the Periodontal Health of Endodontically Treated Primary Molars Correlating with IL-1beta: An In Vivo Study. J Clin Pediatr Dent. 2022 May 1;46(3):199-203. doi: 10.17796/1053-4625-46.3.5.

  PMID: 35830632 RESULT

• Kaptan A, Korkmaz E. Evaluation of success of stainless steel crowns placed using the hall technique in children with high caries risk: A randomized clinical trial. Niger J Clin Pract. 2021 Mar;24(3):425-434. doi: 10.4103/njcp.njcp_112_20.

  PMID: 33723119 RESULT

• Smail-Faugeron V, Porot A, Muller-Bolla M, Courson F. Indirect pulp capping versus pulpotomy for treating deep carious lesions approaching the pulp in primary teeth: a systematic review. Eur J Paediatr Dent. 2016 Jun;17(2):107-12.

  PMID: 27377108 RESULT

• Kopczynski K, Meyer BD. Examining Parental Treatment Decisions Within a Contemporary Pediatric Dentistry Private Practice. Patient Prefer Adherence. 2021 Mar 25;15:645-652. doi: 10.2147/PPA.S300684. eCollection 2021.

  PMID: 33790544 RESULT

• Abdelhafez A, Dhar V. Comparative clinical performance of stainless steel, zirconia, and Bioflx crowns in primary molars: a randomized controlled trial. BMC Oral Health. 2025 Apr 18;25(1):585. doi: 10.1186/s12903-025-05869-8.

  PMID: 40251538 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This research was designed as a randomized controlled trial conducted by a single operator to minimize operator-induced errors. A total sample of 75 primary molars was determined, allowing for potential dropouts, and was evenly distributed into three groups of 25. Each group recieved different crown, groups A for stianless steel crown, group B for zirconia crown and group C for Bioflx crown. At 6 and 12 months follow up, each crown was evaluated clinically such as plaque index , crown retentivity and gingival index.

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

EG (1)