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

The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration: A 5-year Retro-prospective Clinical Study

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

Study Overview

• Status: Completed
• Conditions: Dental Caries; Caries; Dentin
• Intervention / Treatment: Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars

Detailed Description

comparing the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bahçeşehir University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients aged 5-8 years treated with preformed metal crowns using Hall Technique and compomer restoration

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The survival rate of Hall Technique and Compomer Restorations	Successful: restoration satisfactory, no additional treatment required, no clinical sign and symptoms of pulpal pathology or tooth exfoliated,; Minor failure: restoration wear/fracture/loss (restorable) or crown perforation, secondary caries or new caries, reversible pulpitis treated without requiring extraction or pulpotomy,; 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.; The survival analysis: the restorations are assessed as successful or failure.	5 year

Collaborators and Investigators

• Sponsor: Bahçeşehir University
• Investigators: Principal Investigator: Betul Sen Yavuz, Bahçeşehir University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2021
• Primary Completion (ACTUAL): October 3, 2021
• Study Completion (ACTUAL): December 10, 2021

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (ACTUAL): March 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 441555555

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No