NCT02359539

Brief Summary

The use of autogenous graft materials has been recorded to be a gold standard in regenerative therapy. This study directed toward evaluation of two autogenous regenerative materials, marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers for treating intrabony defects. In spite of its reported significant clinical outcomes, the limited availability of the periosteum makes it necessary to evaluate other autogenous alternatives such as PRF that could offer predictable outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2009

Typical duration for phase_2

Status
completed

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

Study Start

First participant enrolled

August 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
Last Updated

February 10, 2015

Status Verified

November 1, 2014

Enrollment Period

2.7 years

First QC Date

November 16, 2014

Last Update Submit

February 9, 2015

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

  • Intrabony defect

    measurements of intrabony gain from CEJ to base of defect

    9 month after surgery

Study Arms (2)

PRF

EXPERIMENTAL

Platelets rich fibrin,

Procedure: Regenerative therapy

MPP

EXPERIMENTAL

Marginal periosteal pedicle

Procedure: Regenerative therapy

Interventions

Regenerative therapyPROCEDURE

Periosteal pedicle, Platelets rich fibrin

Also known as: Guided tissue regeneration
MPPPRF

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • No systemic diseases that could influence the outcome of therapy
  • Good compliance for plaque control instructions after initial therapy
  • Vital teeth
  • Had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth
  • Probing pocket depth (PPD)≥6 mm and clinical attachment level (CAL) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs,

You may not qualify if:

  • Pregnant females and patients presented with opened interproximal contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontal Pocket

Interventions

Guided Tissue Regeneration

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Periodontology Ain Shams University

Study Record Dates

First Submitted

November 16, 2014

First Posted

February 10, 2015

Study Start

August 1, 2009

Primary Completion

April 1, 2012

Study Completion

May 1, 2013

Last Updated

February 10, 2015

Record last verified: 2014-11