Clinical trial NCT03839849: Evaluation of Adjunctive Injectable PRF Therapy Used in Conjunction With Scaling and Root Planning
Official title: Clinical Effectiveness of a Topical Subgingival Application of Injectable Platelet-rich Fibrin as Adjunctive Therapy to Scaling and Root Planing. A Double-blind Split Mouth Randomized Prospective Comparative Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Pockets
Keywords: periodontal pockets
injectable platelet-rich fibrin
saline
Lead sponsor: Syrian Private University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The aim of the study is to evaluate the efficacy of i-PRF subgingival injection right after scaling and root planing as adjunctive therapy to traditional mechanical therapy. 15 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. I-PRF will be applied subgingivally in the deep pockets in a half mouth design. The injected half mouth (study group) for each patient will be allocated randomly. The opposite side will be injected with saline (control group). Clinical parameters will be evaluated: plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL). Clinical measurements will be performed at baseline and at 8 weeks.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: baseline, 2 months
measure: Probing pocket depth (PD)
timeFrame: baseline, 2 months
Secondary outcomes:
measure: full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970)
timeFrame: baseline, 2 months
measure: Modified Gingival Index (Trombelli et al. 2004)
timeFrame: baseline, 2 months
measure: Bleeding on probing (BOP)
timeFrame: baseline, 2 months
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Syrian Private University
Study officials:
affiliation: Syrian Private University
name: Hala Albonni, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Syrian Private University
name: Hazem Sawaf, DDS MSc PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.