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Decayed TeethNCT06706167

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

A study testing stainless steel crown, Zirconia crown and Bioflx crown in people with Decayed Teeth and Carious Lesion, run by Delta University for Science and Technology at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Decayed Teeth, Carious Lesion
What is being tested?
stainless steel crown, Zirconia crown and Bioflx crown
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteEgypt
Study dates
1 Sep 2023to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Delta University For Science and Technology

    Gamasa, El Dakhleia, 11152

Other trials in Egypt

About this study

Official title: Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars: Randomized Control Trial

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.

Being tested
stainless steel crown, Zirconia crown, Bioflx crown
Keywords
primary molars, stainless steel crown, zirconia crown, bioflx crown, clinical evaluation
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stainless steel crownDevice

    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.

  • Zirconia crownDevice

    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 crownDevice

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

Study groups in NCT06706167
Study groupRoleWhat they receive
stainless steel crownActive comparatorParticipants in this arm will receive stainless steel crowns for primary teeth.
Receives: Device: stainless steel crown; Device: Zirconia crown; Device: Bioflx crown
zirconia crownExperimentalParticipants in this arm will receive zirconia crowns for primary teeth.
Receives: Device: stainless steel crown; Device: Zirconia crown; Device: Bioflx crown
Bioflx crownExperimentalParticipants in this arm will receive Bioflex crowns for primary teeth.
Receives: Device: stainless steel crown; Device: Zirconia crown; Device: Bioflx crown

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months and 12 months

Secondary outcomes (1)

  1. crown retention

    Assessed using the USPHS criteria, where "Alpha" indicated the crown was continuous with the existing anatomic form, "Bravo" indicated a missing part of the crown but not enough to expose the underlying dentin/base, and "Charlie" indicated sufficient loss of crown substance to expose the underlying dentin/base or complete loss of the crown

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06706167
Sponsor's protocol ID
DU0240721024
Status last verified
Nov 2024
First submitted
23 Nov 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We are currently reviewing the potential for sharing individual participant data (IPD) following the completion of the study. Factors such as data privacy, participant consent, and regulatory guidelines are being considered. A final decision on data sharing will be made at the conclusion of the study, and the IPD sharing plan will be updated accordingly

Publications

  • 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.

    PubMed 25631720

  • 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.

    PubMed 33845821

  • 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.

    PubMed 24994618

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

    PubMed 25905656

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

  • 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.

    PubMed 23550521

  • 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.

    PubMed 35830632

  • 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.

    PubMed 33723119

  • 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.

    PubMed 27377108

  • 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.

    PubMed 33790544

  • 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.

    PubMed 40251538

Questions about this trial

What is this clinical trial studying?

A study testing stainless steel crown, Zirconia crown and Bioflx crown in people with Decayed Teeth and Carious Lesion, run by Delta University for Science and Technology at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque accumulation (time frame: 6 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06706167, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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