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Trial record 73 of 119 for:    ZIRCONIUM

Patient Satisfaction ,Marginal Integrity ,Shade Matching and Gingival Health of Zirconia Reinforced Lithium Silicate Bridges Cemented Using Bioactive Cement and Adhesive Resin Cement

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ClinicalTrials.gov Identifier: NCT03691597
Recruitment Status : Not yet recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Nihal anwar Mohamed haffour, Cairo University

Brief Summary:
Bioactive cement have been introduced recently into the market according to the manufacture it is assumed that it stimulates mineral apatite formation and the natural remineralization process at the material-tooth interface that knits together the restoration and the tooth, penetrates and fills micro-gaps, reduces sensitivity, guards against secondary caries, and seals margins against microleakage

Condition or disease Intervention/treatment Phase
Patient Satisfaction ,Marginal Integrity, Shade Match and Gingival Health Diagnostic Test: improved patient satisfaction ,marginal integrity, shade match and gingival health Not Applicable

Detailed Description:

To evaluate the cement type (bioactive cement and adhesive resin cement ) on Patient satisfaction ,marginal integrity ,shade matching and gingival health of cemented zirconia reinforced lithium silicate restoration .

PICOTS:

P: patients with missing anterior teeth that needs fixed restoration . I: Bioactive cement. C: adhesive resin cement. O: patient satisfaction ,margin integrity ,shade matching and gingival health T: 1 year


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Satisfaction ,Marginal Integrity ,Shade Matching and Gingival Health of Zirconia Reinforced Lithium Silicate Bridges Cemented Using Bioactive Cement and Adhesive Resin Cement
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Adhesive resin cement
type of cement used for cementation of crowns have a good adhesion bond
Diagnostic Test: improved patient satisfaction ,marginal integrity, shade match and gingival health

For both groups N.Awill make a recall visit after6 months and after 12 months:

  1. Patient satisfaction will be performed according to questionnaire after One year.Questionnaire will contain several questions that evaluate patient satisfaction.
  2. The color will be measured using spectrophotometer Vita easy shade in the same delivery visit ,after 6months and after one year .
  3. Images will be captured using digital handheld light microscope (Celestron 5 Megapixel Resolution, USA) that is fixed on a film holder on a specific distance for the standardization of all the images will be captured by the microscope for all the patients.(22)
  4. Images will be analyzed using imageJ software to measure marginal gap.
  5. Gingival health will be measured using G

Experimental: Bioactive cement
recent cement improve the marginal integrity
Diagnostic Test: improved patient satisfaction ,marginal integrity, shade match and gingival health

For both groups N.Awill make a recall visit after6 months and after 12 months:

  1. Patient satisfaction will be performed according to questionnaire after One year.Questionnaire will contain several questions that evaluate patient satisfaction.
  2. The color will be measured using spectrophotometer Vita easy shade in the same delivery visit ,after 6months and after one year .
  3. Images will be captured using digital handheld light microscope (Celestron 5 Megapixel Resolution, USA) that is fixed on a film holder on a specific distance for the standardization of all the images will be captured by the microscope for all the patients.(22)
  4. Images will be analyzed using imageJ software to measure marginal gap.
  5. Gingival health will be measured using G




Primary Outcome Measures :
  1. margin integrity [ Time Frame: one year ]
    accuracy of adaptation of restoration and close marginal gap



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:" Permanent anterior teeth. " Vital teeth with Absence of clinical diagnosis of pulp exposure, periapical pathosis, fistula, swelling of periodontal tissues, abnormal tooth mobility, and history of spontaneous pain or sensitivity to pressure.

" Healthy appearance of adjacent gingiva.

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Exclusion Criteria:

  • Periapical pathosis, Signs of pulpal pathology, Severe periodontal affection these cases are not indicated for full coverage restoration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691597


Contacts
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Contact: Nihal NA haffour, M.D.s 01123788884 drhaffournihal2009@yahoo.com
Contact: Gihan GN Elnagar, professor 01006607978 ; drgigielnagar@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Gihan GN elnagar, professor faculty of oral and dental medicine Cairo university

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Responsible Party: Nihal anwar Mohamed haffour, Assistant lecturer ,fixed prosthodontics department,faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03691597     History of Changes
Other Study ID Numbers: CEBD-CU-2018-09-41
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Bioactive cement have been introduced recently into the market according to the manufacture it is assumed that it stimulates mineral apatite formation and the natural remineralization process at the material-tooth interface that knits together the restoration and the tooth, penetrates and fills micro-gaps, reduces sensitivity, guards against secondary caries, and seals margins against microleakage

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs