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The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04818658
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Betul Sen Yavuz, Bahçeşehir University

Study Description
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Brief Summary:
The aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

Condition or disease Intervention/treatment
Dental Caries Caries; Dentin Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration: A 5-year Retro-prospective Clinical Study
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Preformed Metal Crowns using Hall Technique Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars
Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.
Compomer Restoration Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars
Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.


Outcome Measures
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Primary Outcome Measures :
  1. The survival rate of Hall Technique and Compomer Restorations [ Time Frame: 5 year ]
    1. Successful: restoration satisfactory, no additional treatment required, no clinical sign and symptoms of pulpal pathology or tooth exfoliated,
    2. Minor failure: restoration wear/fracture/loss (restorable) or crown perforation, secondary caries or new caries, reversible pulpitis treated without requiring extraction or pulpotomy,
    3. Major failure: the tooth is broken down (unrestorable), inter-radicular radiolucency or internal root resorption, signs or symptoms of irreversible pulpitis requiring extraction or pulpotomy.
    4. The survival analysis: the restorations are assessed as successful or failure.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients aged 5-8 years treated with preformed metal crowns using Hall Technique and compomer restoration
Criteria

Inclusion Criteria:

  • patients aged five to eight years at the time of dental treatment,
  • patients attending follow-up appointments
  • patients with compomer restoration and Hall restoration in their teeth
  • patients with matching the extent of caries in the two groups

Exclusion Criteria:

  • patients not attending follow-up appointments
  • patients without both treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818658


Locations
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Turkey
Bahcesehir University
Istanbul, Turkey
Sponsors and Collaborators
Bahçeşehir University
More Information
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Responsible Party: Betul Sen Yavuz, Assistant Professor, Bahçeşehir University
ClinicalTrials.gov Identifier: NCT04818658    
Other Study ID Numbers: 441555555
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases