A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients

NCT07581613 · tracked via the Priya Life Science Spain tracker

Sponsor

Siddharth Shanbhag

Phase

Phase 1/2

Started

2026-11-01

Last updated

2026-05-14

Condition(s) studied

Periodontal DiseaseIntrabony Periodontal Defects

Investigational drug(s) / intervention(s)

HydrogelHydrogel

Hydrogel: A novel cross-linked HA hydrogel incorporating proline-rich peptides (PeriHeal, Corticalis AS, Oslo, Norway) has been developed to enhance periodontal wound healing and regeneration.

Hydrogel: Hyaluronic acid is currently used in periodontal regenerative surgery as a hydrogel mixture of cross-linked (1.6%) and natural (0.2%) HA of bacterial origin, marketed as hyaDENT BG (Regedent AG, Zurich, Switzerland)

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

CAL change — 6 and 12 months after periodontal regenerative surgery
Changes in Clinical Attachment Level (CAL) of the treated teeth

Trial sites (2)

Facility	City	Region	Status
Faculty of Dentistry, University of Oslo	Oslo	Norway
Faculty of Dentistry, University Complutense of Madrid	Madrid	Spain

Other trials for the same condition

Comparison of Autologous Tooth and Bovine Xenograft in Periodontal Healing After Mandibular Third Molar Extraction Recruiting

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 NCT07581613 on ClinicalTrials.gov ↗ ← All trials in Spain