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Completed

NCT Number: NCT04786327

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

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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Key information

Conditions

Periodontal Regeneration Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Malak Mohamed Shoukheba

Tanta, 020, Egypt

About this study

: 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimal invasive flap technique

Procedure

contained defect treated with Minimally invasive flap

Other names: regenerative surgery

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

Procedure

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

Other names: regenerative surgery

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

Combination Product

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

Other names: regenerative surgery

Primary outcomes

  1. the change in probing pocket depth

    Time frame: 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

    Time frame: 9 months

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

  3. the change Clinical attachment level

    Time frame: 9 months

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

  4. Cone beam radiograph

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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