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

• Sponsor: Bahçeşehir University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04818658
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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	Phase
Dental Caries; Caries; Dentin	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 Design

• Study Type: Observational
• Actual Enrollment: 26 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: Mar 8, 2021
• Actual Primary Completion Date: Oct 3, 2021
• Actual Study Completion Date: Dec 10, 2021

Arms and Interventions

Arm	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

Primary Outcome Measures

1. The survival rate of Hall Technique and Compomer Restorations [5 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Bahcesehir University	Istanbul		Turkey

Sponsors and Collaborators

• Bahçeşehir University

Investigators

• Principal Investigator: Betul Sen Yavuz, Bahçeşehir University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Betul Sen Yavuz, Assistant Professor, Bahçeşehir University
• ClinicalTrials.gov Identifier: NCT04818658
• Other Study ID Numbers: 441555555
• First Posted: Mar 26, 2021
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Jul 21, 2022