Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedApril 26, 2022
April 1, 2022
1 year
February 14, 2022
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (3)
Fracture of the restoration
1 year
gingival inflammation
1 year
Recurrent caries
1 year
Other Outcomes (1)
Patient satisfaction
1 year
Study Arms (2)
monolithic zirconia single posterior crowns with deep chamfer finish line
ACTIVE COMPARATORmonolithic 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
EXPERIMENTALmonolithic zirconia single posterior crowns with vertical finish line fabricated by cad cam machine and cemented by self adhesive resin cement.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maha Taymour, PhD
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
February 14, 2022
First Posted
February 23, 2022
Study Start
March 1, 2020
Primary Completion
March 1, 2021
Study Completion
July 1, 2021
Last Updated
April 26, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share