NCT03008538

Brief Summary

Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for 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 P25-P50 for phase_1

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2016

Completed
7 days 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

1 year

First QC Date

December 26, 2016

Last Update Submit

December 30, 2016

Conditions

Bone Graft; Complications

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction regarding function, to be measured using patient questionnaire.

    3 Months.

Secondary Outcomes (1)

  • Comparative histomorphometric analysis, to be measured using a digital software called (leica QWin 500) and unit of measurements are to be (Pixels).

    3 Months.

Study Arms (2)

Mineralized Plasmatic Matrix

EXPERIMENTAL

MPM(Mineralized plasmatic matrix) insertion in extraction sockets for socket preservation for later implant placement and histomorphometric analysis.

Other: MPM(Mineralized plasmatic matrix).

Autogenous Bone Graft (Gold Standards).

ACTIVE COMPARATOR

Socket preservation using Autogenous bone graft for later implant placement and histomorphometric analysis.

Other: Autogenous Bone Graft

Interventions

MPM(Mineralized plasmatic matrix).OTHER

Preparation of sticky bone graft by addition of growth factors obtained from patient's vebous blood.

Also known as: Sticky bone graft.
Mineralized Plasmatic Matrix
Autogenous Bone GraftOTHER

Socket preservation using autogenous bone graft for preservation of bone width and height for future implant insertion.

Also known as: Gold Standards
Autogenous Bone Graft (Gold Standards).

Eligibility Criteria

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

You may qualify if:

  • Medically free patients.
  • Patients with mandibular anterior and premolar hopeless teeth indicated for extraction.
  • Evaluated bone height on X.Ray to be (0-4 mm buccal bone dehiscence).
  • Age between 18 and 40 years.
  • Both sexes.
  • Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
  • Highly motivated patients.

You may not qualify if:

  • Smokers.
  • Pregnant or lactating females.
  • Presence of any pathosis in the pre-implant site.
  • Presence of Para functional habits.
  • History of oral radiotherapy.
  • History of prolonged steroids use
  • Psychological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist Msc

Study Record Dates

First Submitted

December 26, 2016

First Posted

January 2, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

January 2, 2017

Record last verified: 2016-12