NCT03014388

Brief Summary

Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 9, 2017

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

January 5, 2017

Last Update Submit

January 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction regarding aesthetic results will be measured using questionnaire.

    outcome will be measure using questionnaire.

    9 months

Secondary Outcomes (1)

  • Stability of dental implants.

    5 months

Study Arms (2)

Autogenous bone graft (Gold Standard).

EXPERIMENTAL

Patients with defective posterior maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and to be used for bone augmentation with sinus lift.

Other: autogenous bone

Mineralized Plasmatic Matrix (MPM)

EXPERIMENTAL

Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix.

Other: Mineralized plasmatic matrix

Interventions

Autogenous bone graft (gold standard). sinus lift with autogenous bone.

Also known as: Autobone
Autogenous bone graft (Gold Standard).

By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM.

Also known as: MPM
Mineralized Plasmatic Matrix (MPM)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients systemically free.
  • Patients with posterior maxillary defective ridges indicated for sinus lift procedure.
  • Cases with 5 mm bone height or less are included in the study.
  • Age between 18 and 50 years.
  • Both sexes.
  • Patients physically able to tolerate surgical and restorative procedures.
  • Good oral hygiene.
  • Highly motivated patients.

You may not qualify if:

  • Patients allergic to local anesthetic agent.
  • Medium and heavy smokers.
  • Pregnant females.
  • Presence of any pathosis in the pre-implant site.
  • Presence of any mucosal disease.
  • History of oral radiotherapy.
  • History of prolonged steroids use.
  • Psychological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Cairo University CBE

    Cairo University - Ethics Committee.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

refaat ragab, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist at menistry of health

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 9, 2017

Study Start

January 1, 2017

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

January 9, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.