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Completed

NCT Number: NCT03839849

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

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.

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Key information

Conditions

Periodontal Pockets Mouth Diseases Periodontal Diseases Periodontal Pocket Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syrian Private University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

: i-PRF

Procedure

The description of this intervention has been already given before

Saline

Procedure

The description of this intervention has been already given before

Primary outcomes

  1. Clinical attachment level (CAL)

    Time frame: baseline, 2 months

    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")

  2. Probing pocket depth (PD)

    Time frame: baseline, 2 months

    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 outcomes

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

    Time frame: baseline, 2 months

    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.

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

    Time frame: baseline, 2 months

    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

  3. Bleeding on probing (BOP)

    Time frame: baseline, 2 months

    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

Sponsors and collaborators

Lead sponsor

Syrian Private University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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