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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04077606
Recruitment Status : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Nashwa Yehia Abd El Badee Hefnawy, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gingival Inflammation Oral Bacterial Infection Other: ceramo-metallic crown prepartion Other: full anatomical monolithic zirconia crown Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Double blind (trial participants and outcome assessors). Each participant included in this study will be blinded (without knowing type of intervention received).

Blinded assessors :blinding to the laboratory assessors is done by not involving them in sequence generation or allocation concealment or treatment options.

Primary Purpose: Treatment
Official Title: Gingival Inflammatory Response, Bacterial Adhesion And Patient Satisfaction Of Ceramo-Metallic Vs Zirconia Crowns (Randomized Clinical Study)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Zirconium

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 Name: feldspathic porcelain fused to metal

Other: full anatomical monolithic zirconia crown
tooth will be prepared to receive monolithic zirconia crowns
Other Name: 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 Name: feldspathic porcelain fused to metal

Other: full anatomical monolithic zirconia crown
tooth will be prepared to receive monolithic zirconia crowns
Other Name: katana zirconia, Kuraray Noritake , Japan

Primary Outcome Measures :
  1. Gingival inflammatory response [ Time Frame: 12 weeks ]
    presence and concentration of interleukin 1 -beta

Secondary Outcome Measures :
  1. bacterial adhesion [ Time Frame: 12 weeks ]
    colony forming unit

Other Outcome Measures:
  1. patient satisfaction [ Time Frame: 12 weeks ]
    patient satisfaction with yes or no

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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


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Responsible Party: Nashwa Yehia Abd El Badee Hefnawy, Nashwa hefnawy, Cairo University Identifier: NCT04077606     History of Changes
Other Study ID Numbers: CairoUniversity
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nashwa Yehia Abd El Badee Hefnawy, Cairo University:
interleukin 1 beta, bacterial adhesion,monolithic zirconia
Additional relevant MeSH terms:
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Bacterial Infections
Tissue Adhesions
Pathologic Processes
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases