Periodontal DiseasesNCT05858411

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

A study testing SRP+rhPDGF, SRP+L-PRF and MINST alone in people with Periodontal Diseases and Periodontal Attachment Loss, run by G. d'Annunzio University at 1 site in Albania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Periodontal Diseases, Periodontal Attachment Loss, Pocket, Periodontal
What is being tested?: SRP+rhPDGF, SRP+L-PRF and MINST alone
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteAlbania
Study dates: 8 Jan 2023to 1 Sep 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;
3-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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michele Paolantonio, DDS, MD contact

3395204073

michelepaolantonio@gmail.com

Albania1 site, 1 recruiting

University of Medicine of Tirana
Tirana
Recruiting

Other trials in Albania

About this study

Official title: Evaluation of the Efficacy of rhPDGF, L-PRF and EMD as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects: a Randomized Controlled Clinical Trial

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
Being tested: SRP+rhPDGF, SRP+L-PRF, MINST alone, MINST+EMD
Keywords: rhPDGF, Growth factors, Periodontal regeneration, L-PRF, Enamel Matrix Derivatives
Medical subject headings: Periodontal Diseases, Periodontal Attachment Loss, Periodontal Pocket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SRP+rhPDGFProcedure or surgery
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+L-PRFProcedure or surgery
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.
MINST aloneProcedure or surgery
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.
MINST+EMDProcedure or surgery
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.

Study groups in NCT05858411
Study group	Role	What they receive
MINST+rhPDGF	Experimental	After MINST the infrabony defect will be filled with a collagen sponge soaked in rhPDGF. Receives: Procedure: SRP+rhPDGF
MINST+ L-PRF	Active comparator	After MINST the infrabony defect will be filled with a L-PRF membrane. Receives: Procedure: SRP+L-PRF
MINST alone	Active comparator	MINST alone will be performed. Receives: Procedure: MINST alone
MINST+EMD	Active comparator	After MINST the infrabony defect will be filled with EMD gel. Receives: Procedure: MINST+EMD

What is being measured

The primary outcome is the main question the study is designed to answer.

Defect Bone Level (DBL)
Distance between the cemento-enamel junction (CEJ) and the bottom of the defect (BD)
Measured: 12 months
Clinical Attachment Level (CAL)
Distance between the CEJ and the bottom of the pocket
Measured: 12 months

Secondary outcomes (4)

Pocket Probing Depth (PPD)
Distance between the gingival margin and the bottom of the pocket.
Measured: 12 months
Gingival Recession (GR)
Distance between the CEJ and the gingival margin.
Measured: 12 months
Defect Angle (DA)
Angle between the long axis of the tooth and the interproximal wall of the infrabony defect.
Measured: 12 months
Radiographic Defect Area
Area of the triangle defined by: side passing through the top of the interproximal ridge and perpendicular to the long axis of the tooth, side passing through the bottom of the defect and the intersection of the previous side with the root of the tooth, side passing through the top of the ridge and the bottom of the defect.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 20231 Sep 2027

First posted15 May 2023
Study start8 Jan 2023
Primary completion1 Sep 2027 (estimated)
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 88 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05858411
Sponsor's protocol ID: 21042023
Status last verified: May 2026
First submitted: 21 Apr 2023
Last updated: 28 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Michele Paolantonio, DDS, MD

3395204073

michelepaolantonio@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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