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Clinical Trials in Spain / NCT06914518
Starting soon Not applicable

Polynucleotide and Hyaluronic Acid-based Gel as Adjunctive Therapy to Non- Surgical Treatment of Intraosseous Peri-implant Defect. A Randomized Clinical Trial

NCT06914518 · tracked via the Priya Life Science Spain tracker
Sponsor
Universitat Internacional de Catalunya
Phase
Not applicable
Started
2025-09-20
Last updated
2025-09-23

Condition(s) studied

Peri-implantitis

Investigational drug(s) / intervention(s)

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%)Non-Surgical Intervention

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Subjects with (I) ≥ 18 years of age, the presence of at least one implant diagnosed with peri-implantitis, intraosseous ≥ 3mm defects, presence of screw-retained single-unit crowns and partial dental prosthesis that allowed correct access for brushing; and, if not, prostheses that could be modified. Exclusion Criteria: Subjects will be excluded from the study if they had received previous non-surgical peri-implantitis treatment during the last 6 months or surgical treatment, were pregnant or breast-feeding, had received antibiotic treatment in the previous 3 months, had systemic conditions that contraindicated treatment, smoking more than 10 cigarettes/day or presents a poor plaque control (Plaque Index \< 20%), implant mobility.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Clinica Universitaria ́̀ d'Odontologia - UIC Barcelona at the Periodontology Department Sant Cugat del Vallès Barcelona
08195 Sant Cugat del Vallès Bracelona

More Universitat Internacional de Catalunya trials in Spain

Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes Recruiting
Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants. Recruiting
Eco-guided Neuromodulation of the Femoral Nerve on the Performance of Amateur Athletes. Recruiting
Outcome of Endodontic Retreatment in One or Two Visits Recruiting
Wound Healing and Patient-Reported Outcomes After Gingival Graft Harvesting From the Palate Recruiting

Other trials for the same condition

Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis Active, not recruiting
Long-term Stability of Peri-implantitis Treatments: a 3-year Clinical Evaluation Recruiting
Non-Surgical Treatment of Peri-implantitis with Systemic Azithromycin or Placebo Starting soon
Non-surgical Treatment of Peri-implant Pockets With H42 Recruiting
Patient Perspectives Throughout Peri-Implantitis Treatment Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06914518 on ClinicalTrials.gov ↗ ← All trials in Spain