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

Primary Purpose

Periodontal Pockets

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

: i-PRF

saline

About this trial

This is an interventional treatment trial for Periodontal Pockets focused on measuring periodontal pockets, injectable platelet-rich fibrin, saline

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Syrian Private University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

i-PRF (Test)

saline (Control)

Arm Description

injected subgingivally i-PRF after scaling and root planing

injected subgingivally saline after scaling and root planing

Outcomes

Primary Outcome Measures

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")

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")

Secondary Outcome Measures

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

0 No plaque Separate flecks of plaque at the cervical margin of the tooth A thin continuos band of plaque (up to one mm) at the cervical margin of the tooth A band of plaque wider than one mm but covering less than one-third of the crown of the tooth Plaque covering at least one-third but less than two-thirds of the crown of the tooth Plaque covering two-thirds or more of the crown of the tooth labial/ buccal and lingual surfaces are assessed after using disclosing solution. An index for the entire mouth is determined by dividing the total score by the number surfaces examined.

Modified Gingival Index (Trombelli et al. 2004)

0 = Normal gingiva; = Mild inflammation - slight change in color and slight edema; = Moderate inflammation - redness, edema and glazing; = Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. will be evaluated visually

Bleeding on probing (BOP)

All six sites of all teeth are assessed with regard to whether probing elicits bleeding (+) or not (-). The severity of gingivitis is expressed as a percentage. - no bleeding upon probing (not recorded) + bleeding upon probing Calculation: BOP= Number of bleeding sites x100/ Number of sites evaluated will be evaluated visually and used a UNC-15 mm "University of North Carolina" periodontal probe

Full Information

NCT ID

NCT03839849

First Posted

January 27, 2019

Last Updated

May 12, 2020

Sponsor

Syrian Private University

1. Study Identification

Unique Protocol Identification Number

NCT03839849

Brief Title

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

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

February 9, 2019 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syrian Private University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Pockets

Keywords

periodontal pockets, injectable platelet-rich fibrin, saline

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

i-PRF (Test)

Arm Type

Experimental

Arm Description

injected subgingivally i-PRF after scaling and root planing

Arm Title

saline (Control)

Arm Type

Active Comparator

Arm Description

injected subgingivally saline after scaling and root planing

Intervention Type

Procedure

Intervention Name(s)

: i-PRF

Intervention Description

The description of this intervention has been already given before

Intervention Type

Procedure

Intervention Name(s)

saline

Intervention Description

The description of this intervention has been already given before

Primary Outcome Measure Information:

Title

Clinical attachment level (CAL)

Description

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")

Time Frame

baseline, 2 months

Title

Probing pocket depth (PD)

Description

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")

Time Frame

baseline, 2 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

baseline, 2 months

Title

Modified Gingival Index (Trombelli et al. 2004)

Description

Time Frame

baseline, 2 months

Title

Bleeding on probing (BOP)

Description

Time Frame

baseline, 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hala Albonni, DDS MSc

Organizational Affiliation

Syrian Private University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hazem Sawaf, DDS MSc PhD

Organizational Affiliation

Syrian Private University

Official's Role

Study Chair

Facility Information:

Facility Name

Syrian Private University

City

Damascus

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28154995

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.

Results Reference

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PubMed Identifier

30003342

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.

Results Reference

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PubMed Identifier

28351189

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.

Results Reference

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PubMed Identifier

28165420

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.

Results Reference

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PubMed Identifier

30294166

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.

Results Reference

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

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