Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs

Not Applicable

• Conditions: Gingival Recession, Localized
• Interventions: Procedure: Deep chamfer finish line preparation; Procedure: Feather edge finish line preparation

• Registration Number: NCT04729569
• Lead Sponsor: Cairo University

Brief Summary

The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.

Detailed Description

The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.

Gingival bleeding on probing will be evaluated before treatment. Preparation for all ceramic full coverage restoration will be performed according to manufacturer instructions by one operator. Type of finish line (whether feather edge or deep chamfer finish line) will be selected randomly according to a computer generated randomization list. Restorative margins will be placed subgingivally. Zirconia crowns will be fabricated for the prepared teeth and cemented using resin luting agent. At 6 months and 12 months after the cementation, restorative margin position relative to the gingival margin will be recorded. Bleeding on probing and marginal adaptation will also be recorded.

Study Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28
• Study Start: 2021-11-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients 18 years to 50 years old
• Dentate patients planned for a single full coverage restoration in the posterior area.
• Patients with no active periodontal disease.
• >2mm of keratinized tissue

Exclusion Criteria

• Smoking (>10 cigarettes a day)
• Substance abuse history
• Patients with poor oral hygiene and high caries index
• Patients suffering from abnormal occlusal habits for example clenching or bruxism
• Local or systemic disease (endocrine, renal, hematologic, hepatic, immunosuppressive)
• Current steroid/chemotherapy
• Head and neck irradiation
• Pregnancy
• Inability or unwillingness to return for follow up visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator finish line preparation	Deep chamfer finish line preparation	Deep chamfer finish line preparation (Comparator)
Tested finish line preparation	Feather edge finish line preparation	Feather edge finish line preparation (Intervention)

Primary Outcome Measures

Name	Time	Method
Position of the margin of the restoration in relation to the gingival margin position	1 year	Scoring proposed by Paniz et al classified into either subgingival (not visible), equigingival (slightly visible) and supragingival (visible)

Secondary Outcome Measures

Name	Time	Method
Bleeding on probing	1 year	Scoring following Ainamo and Bay gingival bleeding index