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Dental Caries in ChildrenNCT06305845

Digital Crowns Versus Prefabricated Crowns on Primary Teeth

A study testing Digital crowns and zirconia crowns in people with Dental Caries in Children, run by National Research Centre, Egypt at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. Read more about this study

Who is it for?
Ages 4 to 10 years
Conditions the study is for
Dental Caries in Children
What is being tested?
Digital crowns and zirconia crowns
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteEgypt
Study dates
1 Jun 2023to 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 4 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients within the age group of 4-10years. Badly decayed or multi-surface affected primary teeth Healthy children free of any systemic disease Patients with cooperative behavior rating definitely positive or positive on the Frank rating scale

Who cannot join

  • Teeth with developmental disturbances
  • Teeth with poor prognosis as signs of necrosis, extensive pathological root resorption
  • patients with parafunctional habits

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • National Research Centre

    Cairo

Other trials in Egypt

About this study

Official title: Crowns Fabricated Digitally by CAD-CAM Technology Versus Prefabricated Crowns on Primary Teeth

Badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. For the intervention group, teeth will be prepared to receive the digital crown after intraoral scanning while for the control group, teeth will be prepared to receive the prefabricated zirconia crowns. Teeth will be followed up clinically for 1 year, at 1, 6 and 12 months.

Read the detailed description

This is a 12-month randomized, controlled, two parallel arms clinical trial. Patients aging from 4 to 10 years with multi-surface decay will be selected. After caries removal and pulp exposure, pulpotomy or partial pulpectomy technique will be performed,then the teeth will be randomized to the interventional group of digital crowns or to the control group of prefabricated zirconia crowns. For preparation of digital crowns, the occlusal reduction was done by 1.5-2 mm. The proximal contacts will be broken and the entire clinical crown structure was reduced by 0.8-1.0 mm , followed by a a subgingival finish line . For the scanning procedure, the upper and lower arches will be scanned with intra oral scanner, and making sure every point is well detailed . A third scan of the occlusal bite is then performed in order to establish the patient's occlusion.

For the milling procedure, Brilliant Crios composite the blocks will be used and milled with the CEREC MC X milling unit . The inner surface of the crown will be sandblasted with Al2O3 .

For zirconia crown preparation, occlusal reduction of 1.5-2mm will be performed by a football diamond bur. The occlusal third of the buccal and lingual surfaces will be also reduced . The whole crown will be reduced by 0.8-1.0 mm by means of a tapered diamond stone .A shoulder finish line will be created. The try in crown will be tested, then the shoulder finish line will be removed and the preparation will be extended subgingivally to feather-edge.

The crowns will then be cemented with the self-adhesive resin cement (Solocem, Coltene, Whaledent, Altstatten, Switzerland) .Light curing was performed while applying pressure on the crown and then waiting for 5 minutes for complete cementing

Being tested
Digital crowns, zirconia crowns
Keywords
digital crowns, zirconia crowns, primary teeth

What participants receive

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

  • Digital crownsProcedure or surgery

    Also called CAD-CAM fabricated crowns

    crowns fabricated digitally by CAD-CAM technology

  • zirconia crownsProcedure or surgery

    Also called prefabricated crowns

    crowns that are ready made for primary teeth

Study groups in NCT06305845
Study groupRoleWhat they receive
Digital crownsExperimentalCrowns that are fabricated digitally by mean of CAD-CAM technology will be placed after preparation. Tooth preparation will include 1.5-2 mm. occlusal reduction and proximal contacts will be opened and the entire clinical crown structure will be reduced by 0.8-1.0 mm.and the preparation will be finished with a subgingival finish line. Upper and lower arches will be scanned with an intra oral scanner. A third scan of the occlusal bite is then performed in order to establish the patient's occlusion. Brilliant Crios composite blocks will be milled with the CEREC MC X milling unit and the inner surface of the crown will be sandblasted followed by etching with 5% hydrofluoric acid for 60 seconds.
Receives: Procedure: Digital crowns
Zirconia crownsActive comparatorPrefabricated zirconia crowns that are ready made and supplied in kits with their try-ins will be used in this arm. Occlusal reduction of 1.5-2 mm. will be performed by a football diamond bur. The whole crown will be reduced by 0.8-1.0 mm by means of a tapered diamond stone. A shoulder finish line will be created. The try in crown will be tested. Then the shoulder finish line will be removed and the preparation will be extended subgingivally to a feather-edge.
Receives: Procedure: zirconia crowns

What is being measured

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

  1. Patient and parent satisfaction

    5-point Likert scale for patient and parent satisfaction.(1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)

    Measured: 1, 6 and 12 months

Secondary outcomes (4)

  1. Retention of the crowns

    It will be recorded by clinical examination as a binary outcome; Yes: if crown is retentive \& No: if crown is unretentive

    Measured: 1, 6 and 12 months

  2. Gingival inflammation

    It was measured by gently inserting the tip of a periodontal probe into the sulcus surrounding each crowned tooth. Scoring as follows:

    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

    Measured: 1, 6 and 12 months

  3. Color match

    The color match will be recorded in natural light with the patient in the upright position for 5 to 10 seconds. No noticeable difference from adjacent teeth, Slight shade mismatch , Obvious shade mismatch and will be recorded digitally by vita easy shade

    Measured: 1, 6 and 12 months

  4. Opposing tooth wear

    The wear of opposing teeth for the crowns placed will be measured by Smith and Knight Index and it will be measured digitally by a software

    Measured: 1, 6 and 12 month

Timeline

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

  1. First posted12 Mar 2024
  2. Study start1 Jun 2023
  3. Primary completion20 Sep 2023
  4. Study completionSep 2024 (estimated)

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
a randomized clinical trial with two parallel arms
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305845
Sponsor's protocol ID
152012023
Status last verified
Mar 2024
First submitted
5 Mar 2024
Last updated
31 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All required data will be published in the manuscript or upon request

Publications

  • Prabhu D, Anantharaj A, Praveen P, Rani SP, Sudhir R. A clinical and radiographic comparative evaluation of custom-made zirconia crowns using CAD-CAM and stainless steel crowns in primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):34-42. doi: 10.4103/jisppd.jisppd_269_21.

    PubMed 35439881

  • Holsinger DM, Wells MH, Scarbecz M, Donaldson M. Clinical Evaluation and Parental Satisfaction with Pediatric Zirconia Anterior Crowns. Pediatr Dent. 2016;38(3):192-7.

    PubMed 27306242

  • Mourouzis P, Arhakis A, Tolidis K. Computer-aided Design and Manufacturing Crown on Primary Molars: An Innovative Case Report. Int J Clin Pediatr Dent. 2019 Jan-Feb;12(1):76-79. doi: 10.5005/jp-journals-10005-1591.

    PubMed 31496579

  • 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.

    PubMed 33535245

Questions about this trial

What is this clinical trial studying?

A study testing Digital crowns and zirconia crowns in people with Dental Caries in Children, run by National Research Centre, Egypt 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 May 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?

Results are not available in the source record.

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?

Patient and parent satisfaction (time frame: 1, 6 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 NCT06305845, which also lists 4 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 31 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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