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

NCT ID: NCT03691597

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-07-15

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

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

Conditions

Patient Satisfaction ,Marginal Integrity, Shade Match and Gingival Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Adhesive resin cement

type of cement used for cementation of crowns have a good adhesion bond

Group Type: ACTIVE_COMPARATOR

improved patient satisfaction ,marginal integrity, shade match and gingival health

Intervention Type: DIAGNOSTIC_TEST

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

Bioactive cement

recent cement improve the marginal integrity

Group Type: EXPERIMENTAL

improved patient satisfaction ,marginal integrity, shade match and gingival health

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

" Healthy appearance of adjacent gingiva.

-

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nihal anwar Mohamed haffour

Assistant lecturer ,fixed prosthodontics department,faculty of oral and dental medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gihan GN elnagar, professor

Role: STUDY_DIRECTOR

faculty of oral and dental medicine Cairo university

Central Contacts

Nihal NA haffour, M.D.s

Role: CONTACT

drhaffournihal2009@yahoo.com

01123788884

Gihan GN Elnagar, professor

Role: CONTACT

; drgigielnagar@yahoo.com

01006607978

Other Identifiers

CEBD-CU-2018-09-41

Identifier Type: -

Identifier Source: org_study_id