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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04786327
Acronym
RCT
Enrollment
21
Registered
2021-03-08
Start date
2018-01-01
Completion date
2019-10-01
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Regeneration

Keywords

Chronic periodontitis, Intra-bony defects, Minimally invasive surgical technique, Platelet rich fibrin,, Growth factor enhanced matrix 21S

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

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.

Interventions

PROCEDUREMinimal invasive flap technique

contained defect treated with Minimally invasive flap

PROCEDUREMinimally 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

COMBINATION_PRODUCTminimally 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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
the change in probing pocket depth9 monthsthe change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe
the change bleeding on probing score9 monthsthe change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period
the change Clinical attachment level9 monthsthe change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe
Cone beam radiograph9 monthsCone 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026