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

Primary Purpose

Gingival Inflammation, Oral Bacterial Infection

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ceramo-metallic crown prepartion
full anatomical monolithic zirconia crown
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Inflammation focused on measuring interleukin 1 beta, bacterial adhesion,monolithic zirconia

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ceramo-metallic crown

    monolithic zirconia crown

    Arm Description

    ceramo-metallic crown preparation

    monolithic zirconia crown preparation

    Outcomes

    Primary Outcome Measures

    Gingival inflammatory response
    presence and concentration of interleukin 1 -beta

    Secondary Outcome Measures

    bacterial adhesion
    colony forming unit

    Full Information

    First Posted
    August 19, 2019
    Last Updated
    August 30, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04077606
    Brief Title
    Gingival Inflammatory Response,Bacterial Adhesion and Patient Satisfaction of Ceramo-metallic vs Zirconia Crowns
    Acronym
    CairoU
    Official Title
    Gingival Inflammatory Response, Bacterial Adhesion And Patient Satisfaction Of Ceramo-Metallic Vs Zirconia Crowns (Randomized Clinical Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    December 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Inflammation, Oral Bacterial Infection
    Keywords
    interleukin 1 beta, bacterial adhesion,monolithic zirconia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ceramo-metallic crown
    Arm Type
    Active Comparator
    Arm Description
    ceramo-metallic crown preparation
    Arm Title
    monolithic zirconia crown
    Arm Type
    Active Comparator
    Arm Description
    monolithic zirconia crown preparation
    Intervention Type
    Other
    Intervention Name(s)
    ceramo-metallic crown prepartion
    Other Intervention Name(s)
    feldspathic porcelain fused to metal
    Intervention Description
    tooth will be prepared to receive ceramo-metallic crowns
    Intervention Type
    Other
    Intervention Name(s)
    full anatomical monolithic zirconia crown
    Other Intervention Name(s)
    katana zirconia, Kuraray Noritake , Japan
    Intervention Description
    tooth will be prepared to receive monolithic zirconia crowns
    Primary Outcome Measure Information:
    Title
    Gingival inflammatory response
    Description
    presence and concentration of interleukin 1 -beta
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    bacterial adhesion
    Description
    colony forming unit
    Time Frame
    12 weeks
    Other Pre-specified Outcome Measures:
    Title
    patient satisfaction
    Description
    patient satisfaction with yes or no
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17586152
    Citation
    Griggs JA. Recent advances in materials for all-ceramic restorations. Dent Clin North Am. 2007 Jul;51(3):713-27, viii. doi: 10.1016/j.cden.2007.04.006.
    Results Reference
    background
    PubMed Identifier
    25048249
    Citation
    Lekesiz H. Reliability estimation for single-unit ceramic crown restorations. J Dent Res. 2014 Sep;93(9):923-8. doi: 10.1177/0022034514544215. Epub 2014 Jul 21.
    Results Reference
    background
    PubMed Identifier
    25842099
    Citation
    Sailer I, Makarov NA, Thoma DS, Zwahlen M, Pjetursson BE. All-ceramic or metal-ceramic tooth-supported fixed dental prostheses (FDPs)? A systematic review of the survival and complication rates. Part I: Single crowns (SCs). Dent Mater. 2015 Jun;31(6):603-23. doi: 10.1016/j.dental.2015.02.011. Epub 2015 Apr 2. Erratum In: Dent Mater. 2016 Dec;32(12 ):e389-e390.
    Results Reference
    background
    PubMed Identifier
    4575207
    Citation
    Hobo S, Shillingburg HT Jr. Porcelain fused to metal: tooth preparation and coping design. J Prosthet Dent. 1973 Jul;30(1):28-36. doi: 10.1016/0022-3913(73)90075-9. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24762856
    Citation
    Sun T, Zhou S, Lai R, Liu R, Ma S, Zhou Z, Longquan S. Load-bearing capacity and the recommended thickness of dental monolithic zirconia single crowns. J Mech Behav Biomed Mater. 2014 Jul;35:93-101. doi: 10.1016/j.jmbbm.2014.03.014. Epub 2014 Apr 2.
    Results Reference
    background
    PubMed Identifier
    25985741
    Citation
    Baladhandayutham B, Lawson NC, Burgess JO. Fracture load of ceramic restorations after fatigue loading. J Prosthet Dent. 2015 Aug;114(2):266-71. doi: 10.1016/j.prosdent.2015.03.006. Epub 2015 May 16.
    Results Reference
    background
    PubMed Identifier
    9916767
    Citation
    Piconi C, Maccauro G. Zirconia as a ceramic biomaterial. Biomaterials. 1999 Jan;20(1):1-25. doi: 10.1016/s0142-9612(98)00010-6.
    Results Reference
    background
    PubMed Identifier
    18440062
    Citation
    Chen YM, Smales RJ, Yip KH, Sung WJ. Translucency and biaxial flexural strength of four ceramic core materials. Dent Mater. 2008 Nov;24(11):1506-11. doi: 10.1016/j.dental.2008.03.010. Epub 2008 Apr 25.
    Results Reference
    background
    PubMed Identifier
    18620748
    Citation
    Beuer F, Schweiger J, Eichberger M, Kappert HF, Gernet W, Edelhoff D. High-strength CAD/CAM-fabricated veneering material sintered to zirconia copings--a new fabrication mode for all-ceramic restorations. Dent Mater. 2009 Jan;25(1):121-8. doi: 10.1016/j.dental.2008.04.019. Epub 2008 Jul 11.
    Results Reference
    background
    PubMed Identifier
    11155185
    Citation
    Goldberg PV, Higginbottom FL, Wilson TG. Periodontal considerations in restorative and implant therapy. Periodontol 2000. 2001;25:100-9. doi: 10.1034/j.1600-0757.2001.22250108.x.
    Results Reference
    background
    PubMed Identifier
    11203559
    Citation
    Gunay H, Seeger A, Tschernitschek H, Geurtsen W. Placement of the preparation line and periodontal health--a prospective 2-year clinical study. Int J Periodontics Restorative Dent. 2000 Apr;20(2):171-81.
    Results Reference
    background
    PubMed Identifier
    15635955
    Citation
    Lang NP, Berglundh T, Heitz-Mayfield LJ, Pjetursson BE, Salvi GE, Sanz M. Consensus statements and recommended clinical procedures regarding implant survival and complications. Int J Oral Maxillofac Implants. 2004;19 Suppl:150-4. No abstract available.
    Results Reference
    background
    PubMed Identifier
    25882973
    Citation
    Zenthofer A, Ohlmann B, Rammelsberg P, Bomicke W. Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study. J Prosthet Dent. 2015 Jul;114(1):34-9. doi: 10.1016/j.prosdent.2015.02.006. Epub 2015 Apr 14.
    Results Reference
    background
    PubMed Identifier
    25515271
    Citation
    Kato A, Imai K, Ochiai K, Ogata Y. Prevalence and quantitative analysis of Epstein-Barr virus DNA and Porphyromonas gingivalis associated with Japanese chronic periodontitis patients. Clin Oral Investig. 2015 Sep;19(7):1605-10. doi: 10.1007/s00784-014-1387-y. Epub 2014 Dec 18.
    Results Reference
    background
    PubMed Identifier
    9151548
    Citation
    Reddy MS. The use of periodontal probes and radiographs in clinical trials of diagnostic tests. Ann Periodontol. 1997 Mar;2(1):113-22. doi: 10.1902/annals.1997.2.1.113.
    Results Reference
    background

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

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