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OpenTrials
Completed

NCT Number: NCT05252689

Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer

It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and post-operative sensitivity. In comparison with the vertical preparation technique, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

A healthy relationship between dental restorations and the periodontium is of prime importance for the clinical longevity and esthetic harmony of full coverage restorations . One of the Most Common complications, derived from fixed prostheses is gingival recession, which constitutes an important clinical concern. This problem is largely associated with iatrogenic effects produced during dental preparation or as a result of poor prosthetic fit which can cause chronic inflammation leading to gingival margin recession around the restoration .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients in this study will be in the range of 18-50 years
  • Have no active periodontal or pulpal diseases, have teeth with good restorations
  • Psychologically and physically able to withstand conventional dental procedures
  • Able to return for follow-up examinations and evaluation
  • No tooth mobility or grade 1 can be accepted
  • Patients with teeth problems indicated for single posterior crowns:
  • Badly decayed teeth
  • Teeth restored with large filling restorations
  • Endodontically treated teeth
  • Malformed teeth
  • Malposed teeth (Tilted, over-erupted, rotated, etc.)
  • Spacing between posterior teeth

Exclusion criteria

  • Patients under the age of 18 or being incapable of taking out a contract
  • Patient with active resistant periodontal diseases
  • Patients with any medical condition that impaired correct oral hygiene
  • a conspicuous medical or psychological history
  • bruxism, or known allergic reaction to the materials used.
  • pregnant female patients

Treatment and study plan

monolithic zirconia single posterior crowns with deep chamfer finish line

Other

deep chamfer of 1 mm average thickness for cervical finish line, a convergence angle of 6-12° on each side and up to 20° total, in some studies, is acceptable and occlusal reduction of 1,5-2 mm

monolithic zirconia single posterior crowns with vertical finish line

Other

using special round-ended 2 degrees tapered diamond burs a non-working tip (batt bur). It has coronal diameter of 1.2 mm, apical diameter of 0.7 mm, and non- cutting end of 1 mm, which reduces or avoids damage to the connective attachment and allows a tooth-guided preparation procedure

Primary outcomes

  1. Marginal adaptation

    Time frame: 1 year

    Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.

    Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.

    Charlie (C) Visible evidence of crevice and penetration of the explorer.

Secondary outcomes

  1. Fracture of the restoration

    Time frame: 1 year

    Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) Smooth surface of the restoration (shiny after air drying)

    Bravo (B) Dull surface and/or chipping of porcelain that does not impair function

    Charlie (C) Chipping of veneering material impairing esthetics and function and/or exposing framework material

  2. gingival inflammation

    Time frame: 1 year

    Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) Normal gingiva

    Bravo (B) Mild inflammation - slight change in color and slight edema but no bleeding on probing;

    Charlie (C) Moderate inflammation redness, edema, and glazing, bleeding on probing;

  3. Recurrent caries

    Time frame: 1 year

    Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No caries present Bravo (B) Caries present

Other outcomes

  1. Patient satisfaction

    Time frame: 1 year

    VAS (Questionnaire) by Numerical (discrete) ("0" unsatisfied - "10" satisfied)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Teeth Prepared With Vertical Preparation Technique Versus Deep Chamfer for Monolithic Zirconia Crowns

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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