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

NCT04786327 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 4
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic periodontitis; Intra-bony defects; Minimally invasive surgical technique; Platelet rich fibrin,; Growth factor enhanced matrix 21S

Outcome Measures

Primary Outcomes (4)

• the change in probing pocket depth

  the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe

  9 months

• the change bleeding on probing score

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

  9 months

• the change Clinical attachment level

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

  9 months

• Cone beam radiograph

  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

  9 months

Study Arms (3)

treated by using Minimally invasive flap only.

PLACEBO COMPARATOR

7 sites treated with Minimally invasive flap only

Procedure: Minimal invasive flap technique

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

Minimal invasive flap technique PROCEDURE

contained defect treated with Minimally invasive flap

Also known as: regenerative surgery

treated by using Minimally invasive flap only.

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

Also known as: regenerative surgery

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 COMBINATION_PRODUCT

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

Also known as: regenerative surgery

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

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Malak Mohamed Shoukheba

Tanta, 020, Egypt

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Edetic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• malak m shoukheba, phd

  tanta university faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate prof

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 8, 2021
• Study Start: January 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)