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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Periodontal Regeneration

Treatments: Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin; Procedure: Minimal invasive flap technique; Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S

Study type: Interventional

Funder types: Other

Identifiers

NCT04786327

4

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups, including a placebo group

treated by using Minimally invasive flap only.

Placebo Comparator group

Description:

7 sites treated with Minimally invasive flap only

Treatment:

Procedure: Minimal invasive flap technique

Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .

Experimental group

Description:

7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft

Treatment:

Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin

MIST with root conditioning (EDTA) and GEM 21S .

Experimental group

Description:

7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S

Treatment:

Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S