Clinical Effectiveness of Biologic Agents as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects

Summary

The aim of the present study is to clinically and radiographically compare the efficacy of recombinant human platelet-derived growth factor (rhPDGF), Leukocyte-Platelet Rich Fibrin (L-PRF) and Enamel Matrix Derivatives (EMD) in intrabony defects following minimally invasive non surgical peridoontal therapy (MINST).

This study will be designed as a randomized clinical trial of 12-month duration. A total of 88 patients (each with a single infrabony defect) will be recruited and randomly equally distributed into 4 groups: an experimental group treated with MINST and rhPDGF, a second group treated with MINST + L-PRF, a third group treated with MINST and EMD and and a control group treated with MINST alone.

Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following MINST experimental and control sites will be randomly chosen. The test sites will be treated by inserting a collagen plug soaked for at least 15 minutes in a 1.5cc solution containing hPDGF-BB. In the second group the infrabony defects will be treated with MINST and L-PRF. In the third group the infrabony defects will be treated with MINST and EMD. The control group will be treated with MINST alone.

Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.

Standardized radiographs of selected study sites will be taken at baseline and at the 6 and 12 months follow-up visits using the long-cone technique with a customized holder and a thermoplastic occlusal reference to allow reproducible positioning. All radiographs will be analysed by a dedicated dental software (Carestream Dental LLC Atlanta, GA, USA) to make linear measurements. The defect bone level (DBL), the defect angle (DA), the intra- and suprabony components of the defect and the radiographic defect area (RDA) will be evaluated.

Conditions

• Periodontal Diseases
• Periodontal Attachment Loss
• Pocket, Periodontal
• Intrabony Periodontal Defect

Interventions

PROCEDURE

SRP+rhPDGF

The infrabony defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of a collagen sponge soaked in rhPDGF.

PROCEDURE

SRP+L-PRF

The infrabony defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and will be treated with the application of a L-PRF membrane.

PROCEDURE

MINST alone

The infrabony defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed.

PROCEDURE

MINST+EMD

The infrabony defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and will be treated with the application of EMD gel.

Sponsors & Collaborators

• G. d'Annunzio University

  lead OTHER

Principal Investigators

• Michele Paolantonio, DDS, MD · University 'G. D'Annunzio' of Chieti

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-08

Primary Completion

2027-09-01

Completion

2027-09-01

Countries

• Albania

Study Locations