NCT03007069

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.

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

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

First Submitted

Initial submission to the registry

December 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 25, 2016

Last Update Submit

December 30, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire.

    5 months

Secondary Outcomes (1)

  • Stability of dental implants , this will be measured using Ostell device in ISQ units.

    5 months.

Study Arms (2)

Autogenous bone graft (Gold Standard).

EXPERIMENTAL

Patients with defective maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and collagen membrane to be used for bone augmentation around exposed threads of inserted dental implants.

Other: Autogenous bone graft (gold standard).

MPM Augmentation.

ACTIVE COMPARATOR

Mineralized plasmatic matrix (MPM) to be used without collagen membrane to augment the defect in the maxillary bone and cover the exposed threads of the dental implants.

Other: Mineralized plasmatic matrix (MPM).

Interventions

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, for 10 minutes , Which will result if sticky bone graft consistency after mixing.

Also known as: Sticky bone graft.
MPM Augmentation.

Exposed implant threads are to be covered with autogenous bone and collagen membrane.

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

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically free patients.
  • Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
  • Patients with Anterior maxillary defective partially edentulous ridge.
  • Age between 18 and 40 years.
  • Both sexes.
  • Patients physically able to tolerate surgical and restorative procedures.
  • Patients with an opposing tooth to the pre-implant site.
  • Good oral hygiene.
  • Highly motivated patients.

You may not qualify if:

  • Patients allergic to local anesthetic agent.
  • Pregnant or lactating females.
  • Presence of any pathosis in the pre-implant site.
  • Presence of any mucosal disease.
  • Presence of parafunctional habits.
  • 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

Interventions

1-methyl-1-piperidinomethane sulfonate

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

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

December 25, 2016

First Posted

January 2, 2017

Study Start

January 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

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