An interventional study of SRP+rhPDGF and SRP+L-PRF in Periodontal Diseases, Periodontal Attachment Loss and Pocket, Periodontal, sponsored by G. d'Annunzio University. Recruiting at 1 site in Albania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment
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.
867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 88 is above the median of 45 across 557 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →G. d'Annunzio University is the lead sponsor of 67 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After MINST the infrabony defect will be filled with a collagen sponge soaked in rhPDGF.
Procedure: SRP+rhPDGF
After MINST the infrabony defect will be filled with a L-PRF membrane.
Procedure: SRP+L-PRF
MINST alone will be performed.
Procedure: MINST alone
After MINST the infrabony defect will be filled with EMD gel.
Procedure: MINST+EMD
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.
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.
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.
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.
Defect Bone Level (DBL)
Distance between the cemento-enamel junction (CEJ) and the bottom of the defect (BD)
Time frame: 12 months
Clinical Attachment Level (CAL)
Distance between the CEJ and the bottom of the pocket
Time frame: 12 months
Pocket Probing Depth (PPD)
Distance between the gingival margin and the bottom of the pocket.
Time frame: 12 months
Gingival Recession (GR)
Distance between the CEJ and the gingival margin.
Time frame: 12 months
Defect Angle (DA)
Angle between the long axis of the tooth and the interproximal wall of the infrabony defect.
Time frame: 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.
Time frame: 12 months
Plan to share: No
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Started Jan 2023 (actual). Primary completion is estimated for Sep 2027, 55 months after the start.
Of 312 non-industry interventional studies with no phase under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's planned 55 months is above that.
Counting every sponsor, half of 331 studies reached it within 13 months; a quarter within 8 and three quarters within 26.
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G. d'Annunzio University