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Polynucleotide and Hyaluronic Acid-based Gel as Adjunctive Therapy to Non- Surgical Treatment of Intraosseous Peri-implant Defect. A Randomized Clinical Trial
Sponsor: Universitat Internacional de Catalunya
Summary
This randomized, placebo-controlled clinical trial evaluates the efficacy of a polynucleotide and hyaluronic acid-based gel (PN-HA) as adjunctive therapy to non-surgical flapless treatment of peri-implantitis. The main goal is to assess probing pocket depth (PPD) reduction after 6 months compared to placebo. Study Design: * Type: Interventional (Clinical Trial) * Allocation: Randomized (computer-generated blocks) * Intervention Model: Parallel assignment * Masking: Single-blind (examiner-blinded) * Primary Purpose: Treatment * Estimated Enrollment: 32 participants * Duration: 6 month follow-up
Official title: Polynucleotide and Hyaluronic Acid-based Gel as Adjunctive Therapy to Non- Surgical Treatment of Intraosseous Peri-implant Defect. A 6-month Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-09-20
Completion Date
2026-06-01
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight > 1500 kDa (10 mg/ml, 1%)
At the end of the standardized peri-implant non-surgical therapy a viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight \> 1500 kDa (10 mg/ml, 1%) (REGENFASTe, Mastelli S.r.l., Sanremo, Italy) will be injected in the peri-implant sulcus.
Non-Surgical Intervention
Standardized peri-implant non-surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing
Locations (2)
Clinica Universitaria ́̀ d'Odontologia - UIC Barcelona at the Periodontology Department
Sant Cugat del Vallès, Barcelona, Spain
08195
Sant Cugat del Vallès, Bracelona, Spain