Clincosm LogoSign in Get a demo

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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04786327
Collaborator
(none)
21
Enrollment
1
Location
3
Arms
21
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Minimal invasive flap technique
  • Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin
  • Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the change in probing pocket depth [9 months]

      the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe

    2. the change bleeding on probing score [9 months]

      the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period

    3. the change Clinical attachment level [9 months]

      the change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe

    4. Cone beam radiograph [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Malak Mohamed Shoukheba Tanta Egypt 020

    Sponsors and Collaborators

    • Tanta University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    malak mohamed shoukheba, associate prof, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04786327
    Other Study ID Numbers:
    • 4
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by malak mohamed shoukheba, associate prof, Tanta University
    Chronic periodontitis
    Intra-bony defects
    Minimally invasive surgical technique
    Platelet rich fibrin,
    Growth factor enhanced matrix 21S
    Additional relevant MeSH terms:
    Edetic Acid
    Mitogens
    Pentetic Acid

    Study Results

    No Results Posted as of Jun 18, 2021