Evaluation of Adjunctive Injectable PRF Therapy Used in Conjunction With Scaling and Root Planning

NCT03839849 | Completed DMC

• 1 other identifier: SPU-DN-Perio-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical evaluation of local administration of injectable PRF (injectable platelet-rich fibrin) in periodontal pockets as adjunctive therapy to scaling and root planing. 15 periodontal patients will receive a through traditional mechanical treatment (scaling and root planing). Each patient will receive subgingival i-PRF injected in half mouth and the opposite side will be injected with saline, immediately after the deep scaling session.

Conditions

Periodontal Pockets

Keywords

periodontal pockets; injectable platelet-rich fibrin; saline

Outcome Measures

Primary Outcomes (2)

• Clinical attachment level (CAL)

  measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")

  baseline, 2 months

• Probing pocket depth (PD)

  measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")

  baseline, 2 months

Secondary Outcomes (3)

• full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970)

  baseline, 2 months

• Modified Gingival Index (Trombelli et al. 2004)

  baseline, 2 months

• Bleeding on probing (BOP)

  baseline, 2 months

Study Arms (2)

i-PRF (Test)

EXPERIMENTAL

injected subgingivally i-PRF after scaling and root planing

Procedure: : i-PRF

saline (Control)

ACTIVE COMPARATOR

injected subgingivally saline after scaling and root planing

Procedure: saline

Interventions

: i-PRF PROCEDURE

The description of this intervention has been already given before

i-PRF (Test)

saline PROCEDURE

The description of this intervention has been already given before

saline (Control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are in general good health.
• Patients are from both gender and are adult.
• A sign informed consent from participation and permission to use obtained data for research purposes.
• They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
• Presence of bilateral periodontal pockets (≥5 mm) on the minimum of 2 teeth in each side.

You may not qualify if:

• Patients less than 18 years' old
• Immunosuppressive systemic diseases (like cancer, AIDS, diabetes…)
• clotting and Hematological disorders
• Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use
• The teeth with poor bad filling and poorly fitted restorations

Sponsors & Collaborators

• Syrian Private University: lead

Study Sites (1)

Syrian Private University

Damascus, Syria

Location

Related Publications (5)

• Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.

  PMID: 28154995 BACKGROUND

• Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.

  PMID: 30003342 BACKGROUND

• Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Effects of an injectable platelet-rich fibrin on osteoblast behavior and bone tissue formation in comparison to platelet-rich plasma. Platelets. 2018 Jan;29(1):48-55. doi: 10.1080/09537104.2017.1293807. Epub 2017 Mar 29.

  PMID: 28351189 BACKGROUND

• Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Behavior of Gingival Fibroblasts on Titanium Implant Surfaces in Combination with either Injectable-PRF or PRP. Int J Mol Sci. 2017 Feb 4;18(2):331. doi: 10.3390/ijms18020331.

  PMID: 28165420 BACKGROUND

• Kour P, Pudakalkatti PS, Vas AM, Das S, Padmanabhan S. Comparative Evaluation of Antimicrobial Efficacy of Platelet-rich Plasma, Platelet-rich Fibrin, and Injectable Platelet-rich Fibrin on the Standard Strains of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S325-S330. doi: 10.4103/ccd.ccd_367_18.

  PMID: 30294166 BACKGROUND

MeSH Terms

Conditions

Periodontal Pocket

Interventions

proliferation regulatory factors, human urine; Sodium Chloride

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hala Albonni, DDS MSc

  Syrian Private University

  PRINCIPAL INVESTIGATOR

• Hazem Sawaf, DDS MSc PhD

  Syrian Private University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: February 15, 2019
• Study Start: February 9, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)