NCT04729569

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

January 24, 2021

Last Update Submit

July 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Bleeding on probing

    1 year

Other Outcomes (1)

  • Marginal adaptation

    1 year

Study Arms (2)

Tested finish line preparation

OTHER

Feather edge finish line preparation (Intervention)

Procedure: Feather edge finish line preparation

Comparator finish line preparation

ACTIVE COMPARATOR

Deep chamfer finish line preparation (Comparator)

Procedure: Deep chamfer finish line preparation

Interventions

Tooth preparation with feather edge finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.

Tested finish line preparation

Tooth preparation with deep chamfer finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.

Comparator finish line preparation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • El-Khayat H, Anwar EM, Nabil O, Aboushahba M. Gingival Recession and Marginal Adaptation of Zirconia Crowns with Two Subgingival Margin Designs: A Randomized Clinical Trial. J Contemp Dent Pract. 2025 Aug 1;26(8):767-775. doi: 10.5005/jp-journals-10024-3932.

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2021

First Posted

January 28, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR