NCT03757195

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

November 27, 2017

Last Update Submit

November 27, 2018

Conditions

Alveolar Ridge Abnormality of Maxilla

Keywords

Mineralized plasmatic matrixsticky boneplasmaautogeous fibrin glue

Outcome Measures

Primary Outcomes (1)

  • amount of bone loss

    amount of bone loss after xenograft by CBCT

    change from baseline at 6 months

Study Arms (1)

augmentation by xenograft

EXPERIMENTAL

xenograft mixed with plasma extracted from blood

Procedure: Augmentation

Interventions

AugmentationPROCEDURE

combination product

augmentation by xenograft

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo Univerisity

Cairo, Egypt

RECRUITING

Cairo University

Cairo, Egypt

NOT YET RECRUITING

Study Officials

  • Tarek I. Abdallah, P.H.D

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Hany M Ahmed, B.D.S

CONTACT

00201091971228hanyyusf4@gmail.com

Tarek I Abdallah, P.H.D

CONTACT

01282931864t_ghareeb@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Oral Surgery in Nahda University

Study Record Dates

First Submitted

November 27, 2017

First Posted

November 28, 2018

Study Start

November 15, 2018

Primary Completion

July 29, 2020

Study Completion

October 25, 2020

Last Updated

November 28, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)