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
About this trial
This is an interventional treatment trial for Gingival Inflammation focused on measuring interleukin 1 beta, bacterial adhesion,monolithic zirconia
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
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
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
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Gingival Inflammatory Response,Bacterial Adhesion and Patient Satisfaction of Ceramo-metallic vs Zirconia Crowns
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