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Crown of Tooth With Poor ContourNCT06456879

Clinical Performance and Convenience of Four Types of Crowns for Primary Molars

A study testing extra-coronal restoration type in people with Crown of Tooth With Poor Contour, run by Mansoura University at 2 sites 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

This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars: The prefabricated commercially available zirconia crowns (NuSmile®) (NZC). Read more about this study

Who is it for?
Ages 4 to 8 years, women only
Conditions the study is for
Crown of Tooth With Poor Contour
What is being tested?
extra-coronal restoration type
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesEgypt
Study dates
5 Feb 2022to 17 May 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 8 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • Children between 4-8 years old.
  • Definitely positive or positive behavior according to Frankl behavior rating scale.
  • The lower second primary molar with one or more indications for crown restoration.

Who cannot join

  • The child does not have occlusal problems or periodontal diseases
  • The child does not take medications that lead to symptoms of periodontal diseases.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • Faculty of Dentistry, Mansoura University

    Al Mansurah, Dakahlia Governorate, 002

  • Mansoura university

    Al Mansurah, Dakahlya, 002

Other trials in Egypt

About this study

Official title: Clinical Performance and Convenience of Three Types of Crowns as Esthetic Alternatives to Stainless Steel Crowns for Primary Molars

This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars:

  • The prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
  • The locally manufactured zirconia crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCZC).
  • The locally manufactured hybrid ceramic crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCHC).
Read the detailed description

Eighty lower second primary molars will be divided into 4 groups:

  • Group 1(n=20): receive 3M™ ESPE™ Stainless Steel crowns for Primary Molars.
  • Group 2 (n=20): receive the prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
  • Group 3 (n=20): receive the locally manufactured zirconia crowns created via (CAD/CAM) system (CCZC).
  • Group 4 (n=20): receive the locally manufactured hybrid ceramic crowns created via (CAD/CAM) system (CCHC).

Clinical and radiographic examination of the primary molar will be conducted to ensure compliance with the study criteria. Oral health instructions will be given to the child and parents then the application of local anesthesia.

  1. Stainless steel crowns: Reduction of occlusal surface by about 1.5 mm using a flame shaped diamond bur to produce a uniform occlusal reduction. Proximal reduction using a long and tapered diamond bur to allow the probe to pass through the contact area. An appropriate size will be selected according to mesiodistal width of the prepared tooth and a trial fit will be carried out before cementation. The crown should remain no more than 1 mm subgingivally.(21)
  2. Zirconia and hybrid ceramic crowns: The appropriate size of the posterior crown will be selected for the tooth chosen for treatment. The occlusal surface will be reduced by 1-2 mm by using a flame bur after evaluation of the occlusal relationships. The interproximal areas will be opened followed by reduction of the crown dimensions by 0.5-1.25 mm using a tapered diamond bur making the contour of the prepared tooth consistent with the natural contour. The prepared tooth walls will be finished with a 1-2 mm subgingival feather-edge preparation using a thinner pointed tapered diamond bur. The selected crown will be tested for appropriate fit before the final cementation. Finally, the prepared tooth will be cleaned from saliva, blood, and the remnants of preparation and ready for cementation.(15) The selected crown will be cleaned and then filled with resin modified glass ionomer cement. The crown will be applied with no resistance to the fully seated position on the tooth (Passive Fit) since forcing the crown to place can produce micro-fractures in the zirconia structure. Excess cement will be removed using a dental probe and dental floss. Clinical evaluation:
  • Evaluation criteria concerning the clinical performance are
  1. The Gingival Index (GI)(22) will be measured by the William Gingival Probe with a blunt-ended instrument gently placed within the gingival gutter around each tooth to be crowned/previously crowned, and the values will be as follows: 0 = normal gingiva
  2. = mild inflammation: a slight change in color, slight edema, no bleeding on probing
  3. = moderate inflammation: redness, edema, and glazing, or bleeding on probing
  4. =severe inflammation: marked redness and edema, a tendency toward spontaneous bleeding, ulceration.
  5. Plaque Index (PI)(22) will be measured by passing the gingival probe around each tooth to be crowned/previously crowned, and the values will be as follows: 0 = no plaque

1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.

Crown retention (23) will be measured as follows:

0 = present.

1 = absent.

Crown integrity(24) will be measured as follows:

0 = intact.

  1. = crack present.
  2. = fracture present.
  3. = crown lost.

Marginal adaptation will be measured clinically and radiographically:

  1. All crowns will be evaluated clinically at baseline, 3rd, 6th, 9th and 12th months and scored as follows:(25) 0 = Margin not discernible, probe does not catch.
  2. = Probe catches on margin but no gap on probing.
  3. = Probe catches on margin and a gap on probing.
  4. = Crown fractured or missing. 2) All crowns will be evaluated radiographically at baseline, 6th, and 12th months to check the marginal adaptation.

Color stability(26) will be measured as follows:

0 = Unchanged.

1 = Minor deviation from original. Wear of the antagonistic natural enamel. To evaluate the wear of the antagonistic natural enamel of primary molar, a rubber base impressions will be made immediately (baseline) and at 1 year after cementation. The resulting casts will be scanned (using a 3D scanner), and 3D softare will be used to calculate the maximum amount of linear wear. (27)

  • Evaluation criteria regarding the crown convenience: Time elapsed since the start of tooth preparation till the crown cementation. Anxiety using the Facial Image Scale (FIS).(28) The Facial image scale comprises a row of five faces ranging from very happy to very unhappy. The children were asked to point at which face they felt most like at that moment. The scale is scored by giving a value of one to the most positive affect face and five to the most negative affect face. Facial Image Scale has a fixed number of faces (not a continuous line) for the children to choose from, thus making it easier to score in a clinical situation, and easier for very young children to understand.
Being tested
extra-coronal restoration type
Keywords
crowns, molars, wear, zirconia, hybrid

What participants receive

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

  • extra-coronal restoration typeOther

    primary molar crown type

Study groups in NCT06456879
Study groupRoleWhat they receive
Stainless Steel CrownActive comparatorcrown
Receives: Other: extra-coronal restoration type
• NuSmile zirconia crownActive comparatorcrown
Receives: Other: extra-coronal restoration type
• CAD CAM zirconia crownActive comparatorcrown
Receives: Other: extra-coronal restoration type
• CAD CAM hybrid crownActive comparatorcrown
Receives: Other: extra-coronal restoration type

What is being measured

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

  1. the gingival index

    0 = normal gingiva

    1. = mild inflammation
    2. = moderate inflammation
    3. = severe inflammation

    Measured: 12 months

  2. Crown retention

    0 = present.

    1 = absent.

    Measured: 12 months

  3. Crown integrity

    0 = intact.

    1. = crack present.
    2. = fracture present.
    3. = crown lost.

    Measured: 12 months

  4. Color stability

    0 = Unchanged.

    1. = Minor deviation from original.
    2. = Unacceptable discoloration.

    Measured: 12 months

  5. Plaque Index

    0 = no plaque

    1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.

    Measured: 12 months

Secondary outcomes (1)
  1. wear of opposing natural teeth.

    To evaluate the wear of the antagonistic natural enamel of primary molar, the upper arch was scanned using an intraoral scanner immediately, (6 months and 1 year after cementation. Both 3d images were placed in the same position and compared using the CAD software to calculate the amount of linear wear on millimeters.

    Measured: 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 posted13 Jun 2024
  2. Study start5 Feb 2022
  3. Primary completion17 Jan 2024
  4. Study completion17 May 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
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06456879
Sponsor's protocol ID
M01010222
Status last verified
Mar 2024
First submitted
19 May 2024
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amer DM, Abdellatif AM. In vivo evaluation of the enamel wear of primary molar against four types of crowns using the intra-oral scanner. BMC Oral Health. 2024 Nov 27;24(1):1438. doi: 10.1186/s12903-024-05206-5.

    PubMed 39604941

Questions about this trial

What is this clinical trial studying?

A study testing extra-coronal restoration type in people with Crown of Tooth With Poor Contour, run by Mansoura University at 2 sites 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 3 inclusion and 2 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

the gingival index (time frame: 12 months). The study lists 5 primary outcomes in all. 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 NCT06456879, which also lists 1 linked publication.

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 13 Jun 2024.

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