Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05252689
Collaborator
(none)
40
1
2
16
2.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: monolithic zirconia single posterior crowns with deep chamfer finish line
  • Other: monolithic zirconia single posterior crowns with vertical finish line
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
double blind
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Teeth Prepared With Vertical Preparation Technique Versus Deep Chamfer for Monolithic Zirconia Crowns
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Marginal adaptation [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 Outcome Measures

  1. Fracture of the restoration [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 [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 [1 year]

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

Other Outcome Measures

  1. Patient satisfaction [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  7. Badly decayed teeth

  8. Teeth restored with large filling restorations

  9. Endodontically treated teeth

  10. Malformed teeth

  11. Malposed teeth (Tilted, over-erupted, rotated, etc.)

  12. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo University Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Maha Taymour, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mai Salah Ibrahim Afifi Elgohary, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT05252689
Other Study ID Numbers:
  • CEBD-CU-2019-9-2
First Posted:
Feb 23, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022