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

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

Study Overview

• Status: Unknown
• Conditions: Patient Satisfaction ,Marginal Integrity, Shade Match and Gingival Health
• Intervention / Treatment: Diagnostic test: improved patient satisfaction ,marginal integrity, shade match and gingival health

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

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nihal NA haffour, M.D.s; Phone Number: 01123788884; Email: drhaffournihal2009@yahoo.com
• Study Contact Backup: Name: Gihan GN Elnagar, professor; Phone Number: 01006607978; Email: ; drgigielnagar@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Patient satisfaction will be performed according to questionnaire after One year.Questionnaire will contain several questions that evaluate patient satisfaction.; The color will be measured using spectrophotometer Vita easy shade in the same delivery visit ,after 6months and after one year .; 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); Images will be analyzed using imageJ software to measure marginal gap.; 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: Patient satisfaction will be performed according to questionnaire after One year.Questionnaire will contain several questions that evaluate patient satisfaction.; The color will be measured using spectrophotometer Vita easy shade in the same delivery visit ,after 6months and after one year .; 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); Images will be analyzed using imageJ software to measure marginal gap.; Gingival health will be measured using G

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
margin integrity	accuracy of adaptation of restoration and close marginal gap	one year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Gihan GN elnagar, professor, Faculty of Oral and Dental Medicine Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): July 15, 2021

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2018-09-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No