Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer

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

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

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth; Decayed Teeth; Single Posterior Crowns
• Intervention / Treatment: Other: monolithic zirconia single posterior crowns with deep chamfer finish line; Other: monolithic zirconia single posterior crowns with vertical finish line

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 .

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patients in this study will be in the range of 18-50 years
2. Have no active periodontal or pulpal diseases, have teeth with good restorations
3. Psychologically and physically able to withstand conventional dental procedures
4. Able to return for follow-up examinations and evaluation
5. No tooth mobility or grade 1 can be accepted

6. Patients with teeth problems indicated for single posterior crowns:

   1. Badly decayed teeth
   2. Teeth restored with large filling restorations
   3. Endodontically treated teeth
   4. Malformed teeth
   5. Malposed teeth (Tilted, over-erupted, rotated, etc.)
   6. Spacing between posterior teeth

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: monolithic zirconia single posterior crowns with deep chamfer finish line; monolithic zirconia single posterior crowns with deep chamfer finish line fabricated by cad cam machine and cemented by self adhesive resin cement.	Other: monolithic zirconia single posterior crowns with deep chamfer finish line; 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
EXPERIMENTAL: monolithic zirconia single posterior crowns with vertical finish line; monolithic zirconia single posterior crowns with vertical finish line fabricated by cad cam machine and cemented by self adhesive resin cement.	Other: monolithic zirconia single posterior crowns with vertical finish line; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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;	1 year
Recurrent caries	Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No caries present Bravo (B) Caries present	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	VAS (Questionnaire) by Numerical (discrete) ("0" unsatisfied - "10" satisfied)	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Maha Taymour, PhD, Cairo university

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): March 1, 2021
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (ACTUAL): February 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Pulp Diseases; Dental Caries; Tooth, Nonvital
• Other Study ID Numbers: CEBD-CU-2019-9-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No