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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03757195
Other study ID # CEBC-CU-2017-11-16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2018
Est. completion date October 25, 2020

Study information

Verified date November 2018
Source Cairo University
Contact Hany M Ahmed, B.D.S
Phone 00201091971228
Email hanyyusf4@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A new technique of grafting introduce called Mineralized plasmatic matrix. This technique can be used in grafting in anterior zone giving a good results and bone substitution occur using allograft or xenograft.

The bone graft have a good consistency when it mixed with plasma give easy application, strength and stability of the graft. Also plasma rich with CGF (Cellular growth factors).


Description:

Patients suffering from anterior maxillary vertical and horizontal bone loss will be treated using a xeno-graft mixed with the same patient plasma that extracted from his own blood during the operation this graft will be stabilized by collagen membrane and surgical tags.

Patients will be follow up for 6 months to measure amount of bone loss of the xeno-graft during this period post operative using C.B.C.T


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date October 25, 2020
Est. primary completion date July 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Age: from 20 to 40 years old

- no history of previous grafting.

- no History of previous implant placement

- Medically Free e.g no debilitating diseases

Exclusion Criteria:

- Smoker patients.

- Alcoholic patients

- Pregnant.

- Drug Abusers.

- Hypertensive , Diabetic, having Problems or disease in Kidney and/or liver.

- Thyroid Disease.

- Problem in Vit.D absorption or in calcitonin hormone secretion.

- History of blood transfusion or donating blood less than 4 months.

- Patient under Corticosteroid therapy.

- Neurologicaly unstable patients.

- History of radiotherapy or chemo-therapy.

- Patient undergo Spect C.T Scan less than 4 Months .

Study Design


Related Conditions & MeSH terms

  • Alveolar Ridge Abnormality of Maxilla

Intervention

Procedure:
Augmentation
combination product

Locations

Country Name City State
Egypt Cairo Univerisity Cairo
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary amount of bone loss amount of bone loss after xenograft by CBCT change from baseline at 6 months