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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-10-01

Brief Summary

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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

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: 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.

Conditions

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Periodontal Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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treated by using Minimally invasive flap only.

7 sites treated with Minimally invasive flap only

Group Type PLACEBO_COMPARATOR

Minimal invasive flap technique

Intervention Type PROCEDURE

contained defect treated with Minimally invasive flap

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft

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

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect

Interventions

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Minimal invasive flap technique

contained defect treated with Minimally invasive flap

Intervention Type 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

Intervention Type PROCEDURE

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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regenerative surgery regenerative surgery regenerative surgery

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes