Back to resultsClinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer
Primary Purpose
Single Posterior Crowns, Endodontically Treated Teeth, Decayed Teeth
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
monolithic zirconia single posterior crowns with deep chamfer finish line
monolithic zirconia single posterior crowns with vertical finish line
Sponsored by
About this trial
This is an interventional treatment trial for Single Posterior Crowns
Eligibility Criteria
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
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
monolithic zirconia single posterior crowns with deep chamfer finish line
monolithic zirconia single posterior crowns with vertical finish line
Arm Description
monolithic zirconia single posterior crowns with deep chamfer finish line fabricated by cad cam machine and cemented by self adhesive resin cement.
monolithic zirconia single posterior crowns with vertical finish line fabricated by cad cam machine and cemented by self adhesive resin cement.
Outcomes
Primary Outcome Measures
Marginal adaptation
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 Outcome Measures
Fracture of the restoration
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
gingival inflammation
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;
Recurrent caries
Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No caries present Bravo (B) Caries present
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05252689
Brief Title
Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer
Official Title
Clinical Evaluation of Teeth Prepared With Vertical Preparation Technique Versus Deep Chamfer for Monolithic Zirconia Crowns
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Posterior Crowns, Endodontically Treated Teeth, Decayed Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
monolithic zirconia single posterior crowns with deep chamfer finish line
Arm Type
Active Comparator
Arm Description
monolithic zirconia single posterior crowns with deep chamfer finish line fabricated by cad cam machine and cemented by self adhesive resin cement.
Arm Title
monolithic zirconia single posterior crowns with vertical finish line
Arm Type
Experimental
Arm Description
monolithic zirconia single posterior crowns with vertical finish line fabricated by cad cam machine and cemented by self adhesive resin cement.
Intervention Type
Other
Intervention Name(s)
monolithic zirconia single posterior crowns with deep chamfer finish line
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
monolithic zirconia single posterior crowns with vertical finish line
Intervention Description
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 Outcome Measure Information:
Title
Marginal adaptation
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Fracture of the restoration
Description
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
Time Frame
1 year
Title
gingival inflammation
Description
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;
Time Frame
1 year
Title
Recurrent caries
Description
Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No caries present Bravo (B) Caries present
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
Description
VAS (Questionnaire) by Numerical (discrete) ("0" unsatisfied - "10" satisfied)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Taymour, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer
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