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

Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession, Localized
• Intervention / Treatment: Procedure: Feather edge finish line preparation; Procedure: Deep chamfer finish line preparation

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tested finish line preparation; Feather edge finish line preparation (Intervention)	Procedure: Feather edge finish line preparation; Tooth preparation with feather edge finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.
Active Comparator: Comparator finish line preparation; Deep chamfer finish line preparation (Comparator)	Procedure: Deep chamfer finish line preparation; Tooth preparation with deep chamfer finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on probing	Scoring following Ainamo and Bay gingival bleeding index	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal adaptation	Evaluation using Modified USPHS criteria	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 161020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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