Polynucleotide and Hyaluronic Acid-based Gel as Adjunctive Therapy to Non- Surgical Treatment of … (NCT06914518) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.