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

April 15, 2024 updated by: Hala Albonni, Syrian Private University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: i-PRF (Test)
injected subgingivally i-PRF after scaling and root planing
Procedure: : i-PRF
The description of this intervention has been already given before
Active Comparator: saline (Control)
injected subgingivally saline after scaling and root planing
Procedure: saline
The description of this intervention has been already given before

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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")
baseline, 2 months
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")
baseline, 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970)
Time Frame: baseline, 2 months

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.
baseline, 2 months
Modified Gingival Index (Trombelli et al. 2004)
Time Frame: baseline, 2 months

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
baseline, 2 months
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
baseline, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syrian Private University

Investigators

  • Principal Investigator: Hala Albonni, DDS MSc, Syrian Private University
  • Study Chair: Hazem Sawaf, DDS MSc PhD, Syrian Private University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

January 27, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPU-DN-Perio-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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