A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients (NCT07581613) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients
Norway, Spain40 participantsStarted 2026-11-01
Plain-language summary
The goal of this clinical trial is to learn if a novel peptide-rich hydrogel works to achieve periodontal regeneration in adults. It will also learn about the safety of the hydrogel. The main questions it aims to answer are:
* Does the novel peptide hydrogel achieve periodontal regeneration to a similar degree as another currently used therapy (hyaluronic acid)?
* What medical problems, if any, do participants have when receiving the novel hydrogel treatment? Researchers will compare the novel peptide hydrogel to another commonly used hydrogel (hyaluronic acid) to see if the peptide hydrogel works to treat periodontal bone defects.
Participants will:
* Receive the novel hydorgel or hyaluronic acid when they undergo periodontal regenerative surgery
* Visit the clinic at regular intervals for 1 year after the surgery for follow ups
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
* Adults \>18 years with periodontitis (Stage III or IV)
* Systemically healthy (ASA I or II)
* Non-smokers or smoking \<10 cigarettes/day
* Having undergone steps 1 (risk factor control, oral hygiene improvement including interdental hygiene) and 2 (subgingival instrumentation and biofilm control) of systematic periodontal therapy
* Indication for step 3 periodontal therapy, i.e., sites with residual/persistent pockets (PPD \>5 mm and BoP or PPD \>6 mm) around single- or multi-rooted teeth with mobility \<grade II at re-evaluation 8-12 weeks after non-surgical instrumentation (Step 2). Further site-specific criteria include at least one site with a radiographic infrabony defect (2- or 3-walled) with a \>3 mm intrabony component, not associated with an open furcation, indicated for regenerative surgery
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20% before surgery
Exclusion criteria
* Medical conditions contraindicating surgery
* Pregnancy or lactation
* Current use of systemic antibiotics
* Smoking \>10 cigarettes/day
* FMPS or FMBS \>20%
* Mobility grade II or greater
* Acute oral infections, active endo-perio lesions or active carious lesions on teeth associated with bone defects
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.
What they're measuring
1
CAL change
Timeframe: 6 and 12 months after periodontal regenerative surgery