Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect (RCT)

June 15, 2021 updated by: malak mohamed shoukheba, Tanta University

Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.

Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

: Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 020
        • Malak Mohamed Shoukheba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Presence of at least one tooth with PPD and CAL loss of ≥ 5 mm associated with an intra-bony defect of ≥ 2 mm according to Cortellini and Tonetti, 2007

Exclusion Criteria:

  • Patients with uncontrolled or poorly controlled diabetes, life-threatening conditions, or requiring antibiotic prophylaxis were excluded.
  • Smokers
  • Pregnant patients.
  • Patients with aggressive periodontitis.
  • Patients with multiple interconnected vertical defect walls.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: treated by using Minimally invasive flap only.
7 sites treated with Minimally invasive flap only
Procedure: Minimal invasive flap technique
contained defect treated with Minimally invasive flap
Other Names:
  • regenerative surgery
Experimental: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .
7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft
Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin
contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft
Other Names:
  • regenerative surgery
Experimental: MIST with root conditioning (EDTA) and GEM 21S .
7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S
Combination product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S
contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect
Other Names:
  • regenerative surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in probing pocket depth
Time Frame: 9 months
the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe
9 months
the change bleeding on probing score
Time Frame: 9 months
the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period
9 months
the change Clinical attachment level
Time Frame: 9 months
the change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe
9 months
Cone beam radiograph
Time Frame: 9 months
Cone beam radiograph for measuring the change in area of the defect, depth of the depth and bone density at baseline, 3, 6 and 9 month post operative treatment using OnDemand software of cone beam
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: malak m shoukheba, phd, tanta university faculty of dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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