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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05252689
Other study ID # CEBD-CU-2019-9-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date July 1, 2021

Study information

Verified date April 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 .


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Intervention

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
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

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient satisfaction VAS (Questionnaire) by Numerical (discrete) ("0" unsatisfied - "10" satisfied) 1 year
Primary 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 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
Secondary 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
Secondary Recurrent caries Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No caries present Bravo (B) Caries present 1 year
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