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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03691597
Other study ID # CEBD-CU-2018-09-41
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date July 15, 2021

Study information

Verified date September 2018
Source Cairo University
Contact Nihal NA haffour, M.D.s
Phone 01123788884
Email drhaffournihal2009@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date July 15, 2021
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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.

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms

  • Patient Satisfaction ,Marginal Integrity, Shade Match and Gingival Health

Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary margin integrity accuracy of adaptation of restoration and close marginal gap one year