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Periodontal PocketsNCT03839849

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

A study testing : i-PRF and saline in people with Periodontal Pockets, run by Syrian Private University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Periodontal Pockets
What is being tested?
: i-PRF and saline
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSyria
Study dates
9 Feb 2019to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Syrian Private University

    Damascus

Other trials in Syria

About this study

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

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.

Read the 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.

Being tested
: i-PRF, saline
Keywords
periodontal pockets, injectable platelet-rich fibrin, saline
Medical subject headings
Periodontal Pocket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • : i-PRFProcedure or surgery

    The description of this intervention has been already given before

  • salineProcedure or surgery

    The description of this intervention has been already given before

Study groups in NCT03839849
Study groupRoleWhat they receive
i-PRF (Test)Experimentalinjected subgingivally i-PRF after scaling and root planing
Receives: Procedure: : i-PRF
saline (Control)Active comparatorinjected subgingivally saline after scaling and root planing
Receives: Procedure: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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")

    Measured: baseline, 2 months

  2. 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")

    Measured: baseline, 2 months

Secondary outcomes (3)

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

    0 No plaque

    1. Separate flecks of plaque at the cervical margin of the tooth
    2. A thin continuos band of plaque (up to one mm) at the cervical margin of the tooth
    3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
    4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth
    5. 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.

    Measured: baseline, 2 months

  2. Modified Gingival Index (Trombelli et al. 2004)

    0 = Normal gingiva;

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

    Measured: baseline, 2 months

  3. 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

    Measured: baseline, 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start9 Feb 2019
  3. Primary completion30 Sep 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03839849
Sponsor's protocol ID
SPU-DN-Perio-1
Status last verified
Apr 2024
First submitted
27 Jan 2019
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28154995

  • 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.

    PubMed 30003342

  • 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.

    PubMed 28351189

  • 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.

    PubMed 28165420

  • 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.

    PubMed 30294166

Questions about this trial

What is this clinical trial studying?

A study testing : i-PRF and saline in people with Periodontal Pockets, run by Syrian Private University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical attachment level (CAL) (time frame: baseline, 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03839849, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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