Not Yet RecruitingNot Applicable

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

Spain32 participantsStarted 2025-09-20

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Probing pocket depth

Timeframe: Baseline , 3 months, 6 months

Trial details

NCT IDNCT06914518

SponsorUniversitat Internacional de Catalunya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

MARIA C SOLDINI, dentistry

+393491302895 MARIACOSTANZA.SOLDIN@UIC.ES