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

NCT07581613 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-14

No results posted yet for this 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

Conditions

  • Periodontal Disease
  • Intrabony Periodontal Defects

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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)

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    collaborator OTHER

  • Siddharth Shanbhag

    lead OTHER

Principal Investigators

  • Siddharth Shanbhag, Ph.D. · University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2029-06-30
Completion
2030-06-30

Countries

  • Norway
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07581613 on ClinicalTrials.gov