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

NCT ID: NCT03839849

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-09

Study Completion Date

2019-12-30

Brief Summary

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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

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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.

Conditions

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Periodontal Pockets

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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i-PRF (Test)

injected subgingivally i-PRF after scaling and root planing

Group Type EXPERIMENTAL

: i-PRF

Intervention Type PROCEDURE

The description of this intervention has been already given before

saline (Control)

injected subgingivally saline after scaling and root planing

Group Type ACTIVE_COMPARATOR

saline

Intervention Type PROCEDURE

The description of this intervention has been already given before

Interventions

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: i-PRF

The description of this intervention has been already given before

Intervention Type PROCEDURE

saline

The description of this intervention has been already given before

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syrian Private University

OTHER

Sponsor Role lead

Responsible Party

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Hala Albonni

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala Albonni, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

Syrian Private University

Hazem Sawaf, DDS MSc PhD

Role: STUDY_CHAIR

Syrian Private University

Locations

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Syrian Private University

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 28154995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30003342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28351189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28165420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30294166 (View on PubMed)

Other Identifiers

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SPU-DN-Perio-1

Identifier Type: -

Identifier Source: org_study_id

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