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

Not Applicable

Completed

• Conditions: Periodontal Pockets
• Interventions: Procedure: saline

• Registration Number: NCT03839849
• Lead Sponsor: Syrian Private University

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.

Study Timeline

• Study First Submitted: 2019-01-27
• Study Start: 2019-02-09
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline (Control)	saline	injected subgingivally saline after scaling and root planing

Primary Outcome Measures

Name	Time	Method
Probing pocket depth (PD)	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")
Clinical attachment level (CAL)	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")

Secondary Outcome Measures

Name	Time	Method
Bleeding on probing (BOP)	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
full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970)	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.
Modified Gingival Index (Trombelli et al. 2004)	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

Trial Locations

Locations (1)

Syrian Private University; 🇸🇾 Damascus, Syrian Arab Republic