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

NCT04786327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-06-18

No results posted yet for this study

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

Conditions

  • Periodontal Regeneration

Interventions

PROCEDURE

Minimal invasive flap technique

contained defect treated with Minimally invasive flap

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

COMBINATION_PRODUCT

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • malak m shoukheba, phd · tanta university faculty of dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-10-01
Completion
2019-10-01
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786327 on ClinicalTrials.gov