Gingival Inflammatory Response,Bacterial Adhesion and Patient Satisfaction of Ceramo-metallic vs Zirconia Crowns (CairoU)

August 30, 2019 updated by: Nashwa Yehia Abd El Badee Hefnawy, Cairo University

Gingival Inflammatory Response, Bacterial Adhesion And Patient Satisfaction Of Ceramo-Metallic Vs Zirconia Crowns (Randomized Clinical Study)

Ceramo metallic restoration has proved high success rate over past years as considered to be the gold standard while Monolithic zirconia as fixed dental prostheses have gained attention because of their good fracture strength, low wear of the enamel antagonist and pleasant color .Material composition will affect gingival health and biofilm formation which initiate caries and periodontal diseases.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

For years, the ceramo-metal restoration has been the gold standard in crown and bridge procedures .They have been used for many years and studied extensively. Studies have demonstrated a 94% success rate over a 10-year period and good long-term clinical reliability. Although chipping of veneering porcelain is a possible complication, fracture of the metal framework is uncommon . They require sufficient tooth reduction to allow space for at least 0.3 mm of metal coping and 0.7 mm of veneering porcelain, and a minimum facial reduction of 1.2 mm according to Hobo and Shillingburg. When comparing ceramo-metallic crowns to zirconia crowns, several points are noteworthy. Laboratory testing has determined that the fracture strength of a ceramo-metallic crown using 1.5 mm reduction is similar to zirconia crowns with only 1 mm of reduction5. Some manufacturers have even suggested a 0.6 mm minimum reduction for posterior zircona crowns. Which has led some dentists to prescribe all-zirconia restorations to preserve tooth structure6 Zirconia became popular in dentistry because of the material's excellent mechanical properties which include high strength, fracture toughness and biocompatibility.New monolithic CAD/CAM restorative materials are designed to improve the optical and mechanical properties of the avoid veneering failure .To increase translucency and aesthetics of full-contour zirconia ,some modifications ,such as sintering temperature ,fabrication processes and addition of colouring liquids have been applied. These modifications may affect the mechanical and autocatalytic surface-transformation ((low-temperature degradation (LTD)) properties of zirconia.) The primary etiologic factor of gingival inflammation is a plaque, and by inadequate crown shape its accumulation can be facilitated . A single crown can cause inflammation of the periodontal tissue, if the hygienic principles have not been observed during its production. If the finish line of the artificial crown disrupts the biologic width and is placed in the connective tissue attachment area, the inflammation may occur. Even with increased hygiene, the gingival inflammation can occur, if the crown preparation margin is located deeply subgingivally Taking care of the periodontal tissue health the precision of the preparation margin, tightness of proximal contacts, conformity of the tooth crown anatomic shape, occlusal morphology and surface smoothness must be checked . The contact of the crown and the tooth must be tight and uniform .

While choosing material for crown production it must be taken into account that the bacterial adhesive capacity of the prosthetic material is affected by the surface roughness .asperities, free energy of the surface and composition of materials (it is the lowest for ceramic, but the highest for acrylates).Early-colonizing bacteria play a pivotal role for the subsequent adhesion of cariogenic microorganisms such as Streptococcus mutans and periodontal pathogens such as Tannerella forsythensis, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, which may induce gingival and periodontal inflammation Periodontal diagnosis generally requires measurement of periodontal tissue destruction (e.g., probing pocket depth [PPD] and clinical attachment level [CAL]) and gingival inflammation (e.g., bleeding on probing [BOP] and gingival index [GI]). Although the techniques used are straightforward and noninvasive. These parameters are static and thus reflect disease history and not present disease activity .Therefore, it is necessary to develop diagnostic tests that can identify active periodontal sites, predict future disease progression, and assess response to periodontal treatment. Periodontopathic bacteria increase the risk of periodontitis, and immune responses against bacterial products and subsequent secretion of proinflammatory cytokines are crucial in periodontal tissue destruction .Interleukin-1β (IL-1β) is an important mediator of inflammatory response and is involved in cell proliferation, differentiation, and apoptosis, and in the pathophysiology of periodontitis.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

inclusion criteria

  • Patient age range from 20-50 to be able to read and write in order to sign the informed consent document.
  • Patients physically and psychologically able to tolerate conventional restorative procedures.
  • Patients with no active periodontal and or pulpal diseases, having teeth with good restorations.
  • Patients with root canal treated teeth requiring full coverage restorations.
  • Patients indicated for full coverage (e.g. moderate to severe discoloration, coronal fracture).
  • Patients didn't take antibiotics or anti-inflammatory in the past three months.
  • Surfaces with an adjacent probing pocket depth exceeding 3mm were not included
  • Patients willing to return for follow-up examinations and assessments.

Exclusion criteria:

  • Patients in the growth stage with partially erupted teeth.
  • Patient with poor oral hygiene.
  • Patients with psychiatric problems or unrealistic expectations
  • Patient with no opposite occluding dentition in the area intended for restoration.
  • Patient suffering from Para functional habits.
  • Patient with diabetes mellitus, hypertension and gingivitis or periodontitis which has impact on gingival cervicular fluid level

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ceramo-metallic crown
ceramo-metallic crown preparation
Other: ceramo-metallic crown prepartion
tooth will be prepared to receive ceramo-metallic crowns
Other Names:
  • feldspathic porcelain fused to metal
Other: full anatomical monolithic zirconia crown
tooth will be prepared to receive monolithic zirconia crowns
Other Names:
  • katana zirconia, Kuraray Noritake , Japan
Active Comparator: monolithic zirconia crown
monolithic zirconia crown preparation
Other: ceramo-metallic crown prepartion
tooth will be prepared to receive ceramo-metallic crowns
Other Names:
  • feldspathic porcelain fused to metal
Other: full anatomical monolithic zirconia crown
tooth will be prepared to receive monolithic zirconia crowns
Other Names:
  • katana zirconia, Kuraray Noritake , Japan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival inflammatory response
Time Frame: 12 weeks
presence and concentration of interleukin 1 -beta
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bacterial adhesion
Time Frame: 12 weeks
colony forming unit
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: 12 weeks
patient satisfaction with yes or no
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoUniversity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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