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NCT04729569 Clinical Trial

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

Gingival Recession, Localized Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04729569
Other study ID # 161020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date December 1, 2022

Study information
Verified date July 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

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.
• 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Other Marginal adaptation Evaluation using Modified USPHS criteria 1 year
Primary 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 Bleeding on probing Scoring following Ainamo and Bay gingival bleeding index 1 year
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