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

May 11, 2026 updated by: Siddharth Shanbhag

A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration: a Multicenter Parallel-arm Randomized Clinical Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study (PICOS) is to compare, in adult periodontitis patients (P), the efficacy of a P-HA hydrogel (PeriHeal) (I) to that of a commercial HA hydrogel (hyaDENT BG) (C) for the regenerative treatment of intrabony defects based on CAL changes (O) after 6 and 12 months in a RCT (S).

Additional objectives are to assess (a) changes in secondary clinical and radiographic outcomes, (b) patient-reported outcomes (PROs), and (c) molecular outcomes based on proteomic analysis of gingival crevicular fluid (GCF) (see details below).

The null hypothesis (H0) is that there are no statistically significant differences between P-HA and HA hydrogels in terms of CAL after 6 and 12 months.

The primary outcome is CAL change 6 and 12 months after regenerative surgery. Secondary outcomes measured 6 and 12 months after regenerative surgery include changes in: probing pocket depth (PPD), bleeding on probing (BoP), recession (REC), and MBL. Post-operative wound healing and patient-reported symptoms will be assessed 7 and 14 days after surgery. Patients' oral health-related quality of life (OHRQoL) will be assessed at baseline and 6 and 12 months after surgery. GCF collected at 7, 14 and 30 days after surgery will be analysed using mass spectrometry-based proteomics.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Siddharth V Shanbhag, Ph.D.
  • Phone Number: +4740041647
  • Email: siddhars@uio.no

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway, 0455
        • Faculty of Dentistry, University of Oslo
        • Contact:
          • Siddharth V Shanbhag, Ph.D.
          • Phone Number: +4740041647
          • Email: siddhars@uio.no
  • Spain
      • Madrid, Spain
        • Faculty of Dentistry, University Complutense of Madrid
        • Contact:
          • Mariano Sanz, Ph.D.
          • Phone Number: +34913942021
          • Email: marsan@ucm.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peptide hydrogel
Peptide hydrogel with a proprietary root conditioning/cleaning agent
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.
Other Names:
  • Proline-rich peptide hydrogel
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)
Other Names:
  • Hyaluronic acid hydrogel
Active Comparator: Hyaluronic acid hygrodel
Hyaluronic acid hydrogel with a proprietary root conditioning/cleaning agent
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.
Other Names:
  • Proline-rich peptide hydrogel
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)
Other Names:
  • Hyaluronic acid hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAL change
Time Frame: 6 and 12 months after periodontal regenerative surgery
Changes in Clinical Attachment Level (CAL) of the treated teeth
6 and 12 months after periodontal regenerative surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MBL change
Time Frame: 6 and 12 months after regenerative periodontal surgery
Changes in radiographic Marginal Bone Level (MBL)
6 and 12 months after regenerative periodontal surgery
Gingival Healing Index (GHI)
Time Frame: 7 and 14 days after periodontal regenerative surgery
GHI is used to assess the postsurgery conditions of the interdental papilla based on severity of wound dehiscence: score 3: no wound dehiscence and complete flap closure, score 2: minor wound dehiscence with loss of interdental soft tissue limited to the papillary tip; score 1: major wound dehiscence with incomplete flap closure.
7 and 14 days after periodontal regenerative surgery
Proteomic analysis of gingival crevicular fluid (GCF)
Time Frame: 7, 14 and 30 days after regenerative surgery
Proteomic analysis of GCF from the treated teeth using liquid chromatography mass spectrometry (LC-MS) which semi-quantitatively analyses the total number and type (names and IDs) of proteins present in GCF obtained from the test and control sites.
7, 14 and 30 days after regenerative surgery
Oral health related quality of life
Time Frame: 6 and 12 months after regenerative surgery
Oral health related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) instrument which assesses quality of life based on 14 questions under the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The scale ranges from 0 to 14 with a higher score indicating a worse outcome.
6 and 12 months after regenerative surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siddharth Shanbhag

Collaborators

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Siddharth Shanbhag, Ph.D., University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERIHEAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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