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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03333889
Other study ID # CEBD-CU-2017-11-02
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 2, 2017
Last updated November 5, 2017
Start date January 2018
Est. completion date April 2019

Study information

Verified date November 2017
Source Cairo University
Contact Inas Mahmoud, assistant lecturer
Phone +201008402645
Email inas.adel@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T: Time: 12 months S :Randomized controlled trial research question:For patients receiving implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid abutment crown offer better patient satisfaction , less bone loss and better peri-implant clinical parameters when compared to lithium disilicate hybrid abutment crowns?


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date April 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

1. Patients above 18 years old.

2. Patients able to read and sign the informed consent document.

3. Medically free patients or with controlled systemic disease.

4. Patients with good bone quality and quantity evaluated using C.B.C.T.

5. Patients willing to return for follow-up examinations and evaluation.

6. Patients having single missing recently extracted premolar tooth.

Exclusion Criteria:

1. Young patients in growth stage.

2. Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)

3. Pregnant women to avoid any complication that may occur in dental office.

4. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)

5. Psychiatric problems or unrealistic expectations.

6. Multiple adjacent missing teeth.

7. Patients with bad oral hygiene. -

Study Design


Related Conditions & MeSH terms

  • Hybrid Crowns on Single Implants in Esthetic Zone

Intervention

Other:
Vita Enamic hybrid crown
hybrid ceramic material in the form of mesoblocks where the ceramic block is attached to a ti base .The whole assembly is screw retained superstructure.
emax hybrid crown
high srength glass ceramic that can be milled in sections up to 1mm .

Locations

Country Name City State
Egypt Inas adel mahmoud Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient satisfaction using visual analogue scale (o-unsatisfied up to max 10 satisfied) 12 months
Secondary crestal bone loss using digital subtraction technique 12 months