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

NCT04786327 — Phase 2, Completed, 21 participants, Tanta University

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

RegistryNCT04786327, acronym RCT
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment21 (Actual)
SponsorTanta University (Other)
ConditionsPeriodontal Regeneration
InterventionsMinimal invasive flap technique, Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin, minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S (Procedure, combination product)
Datesstart 2018-01-01, primary completion 2019-10-01, completion 2019-10-01, first posted 2021-03-08, last updated 2021-06-18
Locations1 site in Egypt

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-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
treated by using Minimally invasive flap only.Placebo comparatorProcedure: Minimal invasive flap technique7 sites treated with Minimally invasive flap only
Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .ExperimentalProcedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft
MIST with root conditioning (EDTA) and GEM 21S .ExperimentalCombination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S
  • Minimal invasive flap technique (Procedure), also known as regenerative surgery: contained defect treated with Minimally invasive flap
  • Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin (Procedure), also known as regenerative surgery: contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft
  • minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S (Combination product), also known as regenerative surgery: contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect

+Outcome measures

Primary outcomes

  • 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
  • the change bleeding on probing score [9 months]: the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period
  • 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
  • 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

Sex: All, ages: 30 Years to 55 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Malak Mohamed ShoukhebaTantaEgypt

+Investigators

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

My Notes