Efficacy of rhPDGF as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects

NCT05858411 | Unknown

• 1 other identifier: 21042023
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to clinically and radiographically evaluate the efficacy of recombinant human platelet-derived growth factor (rhPDGF) in intrabony defects following scaling and root planing (SRP). This study will be designed as a randomized clinical trial of 12-month duration. A total of 51 patients (each with a single infrabony defect) will be recruited and randomly equally distributed into 3 groups: an experimental group treated with SRP and rhPDGF, a first control group treated with SRP and collagen sponge and a second control group treated with SRP 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 SRP, 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 first control group the infrabony defects will be treated with SRP and a collagen sponge soaked in saline solution. In the second control sites no further treatment will be carried out. 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) and the radiographic defect area (RDA) will be evaluated.

Conditions

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

Keywords

rhPDGF; Growth factors; Periodontal regeneration

Outcome Measures

Primary Outcomes (2)

• Defect Bone Level (DBL)

  Distance between the cemento-enamel junction (CEJ) and the bottom of the defect (BD)

  12 months

• Clinical Attachment Level (CAL)

  Distance between the CEJ and the bottom of the pocket

  12 months

Secondary Outcomes (4)

• Pocket Probing Depth (PPD)

  12 months

• Gingival Recession (GR)

  12 months

• Defect Angle (DA)

  12 months

• Radiographic Defect Area

  12 months

Study Arms (3)

SRP+rhPDGF

EXPERIMENTAL

After SRP the infrabony defect will be filled with a collagen sponge soaked in rhPDGF.

Procedure: SRP+rhPDGF

SRP+ collagen sponge

ACTIVE COMPARATOR

After SRP the infrabony defect will be filled with a collagen sponge soaked in saline solution.

Procedure: SRP+collagen sponge

SRP alone

ACTIVE COMPARATOR

SRP alone will be performed.

Procedure: SRP alone

Interventions

SRP+rhPDGF PROCEDURE

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.

SRP+rhPDGF

SRP+collagen sponge PROCEDURE

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 collagen sponge soaked in saline solution.

SRP+ collagen sponge

SRP alone PROCEDURE

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.

SRP alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of periodontitis stage III or IV (grades A to C),
• non-smokers or former smokers who quit at least 1 year ago, and
• had not received any periodontal treatment in the 3 months prior to recruitment;
• Presence of at least 1 Infrabony defect (PPD ≥ 5 mm with infrabony defect depth of ≥3mm at screening radiograph);
• One and two wall infrabony defects at screening radiograph and periodontal charting.
• Signed informed consent.

You may not qualify if:

• Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C\>7%, rheumatoid arthritis or any form of immunosuppression;
• Subjects requiring antibiotic prophylaxis;
• wall infrabony defects;
• Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment;
• Presence of furcation defect;
• Chronic intake of NSAIDs or steroids, currently;
• Patients undergoing orthodontic treatment, having removable prosthetic appliances, pregnancy, tumors of the oral cavity or the presence of any psychiatric condition that could affect participation.

Sponsors & Collaborators

• G. d'Annunzio University: lead

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Attachment Loss; Periodontal Pocket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Periodontitis

Study Officials

• Michele Paolantonio, DDS, MD

  University 'G. D'Annunzio' of Chieti

  STUDY CHAIR

Central Study Contacts

Michele Paolantonio, DDS, MD

CONTACT

3395204073; michelepaolantonio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time professor

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 15, 2023
• Study Start: May 8, 2023
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share