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Periodontal DiseasePhase 1/2PERIHEALNCT07581613

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

A Phase 1/2 study testing Hydrogel in people with Periodontal Disease and Intrabony Periodontal Defects, run by Siddharth Shanbhag at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hydrogel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesin 2 countries
Study dates
1 Nov 2026to 30 Jun 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Siddharth V Shanbhag, Ph.D. contact

+4740041647

siddhars@uio.no

Anders Verket, Ph.D. contact

+4722852064

anderver@odont.uio.no

2 sites in 2 countries

Norway1 site

  • Faculty of Dentistry, University of Oslo

    Oslo, 0455

    Siddharth V Shanbhag, Ph.D., +4740041647, siddhars@uio.no

Other trials in Norway

Spain1 site

  • Faculty of Dentistry, University Complutense of Madrid

    Madrid

    Mariano Sanz, Ph.D., +34913942021, marsan@ucm.es

Other trials in Spain

About this study

Official title: 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.
Read more

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
Read the 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.

Being tested
Hydrogel
Keywords
periodontal regeneration, hydrogels
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydrogelBiological

    Also called Proline-rich peptide 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.

  • HydrogelBiological

    Also called Hyaluronic acid 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 groups in NCT07581613
Study groupRoleWhat they receive
Peptide hydrogelExperimentalPeptide hydrogel with a proprietary root conditioning/cleaning agent
Receives: Biological: Hydrogel
Hyaluronic acid hygrodelActive comparatorHyaluronic acid hydrogel with a proprietary root conditioning/cleaning agent
Receives: Biological: Hydrogel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CAL change

    Changes in Clinical Attachment Level (CAL) of the treated teeth

    Measured: 6 and 12 months after periodontal regenerative surgery

Secondary outcomes (4)

  1. MBL change

    Changes in radiographic Marginal Bone Level (MBL)

    Measured: 6 and 12 months after regenerative periodontal surgery

  2. Gingival Healing Index (GHI)

    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.

    Measured: 7 and 14 days after periodontal regenerative surgery

  3. Oral health related quality of life

    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.

    Measured: 6 and 12 months after regenerative surgery

  4. Proteomic analysis of gingival crevicular fluid (GCF)

    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.

    Measured: 7, 14 and 30 days after regenerative surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07581613
Sponsor's protocol ID
PERIHEAL
Acronym
PERIHEAL
Status last verified
May 2026
First submitted
27 Apr 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhu H, Gomez M, Xiao J, Perale G, Betge F, Lyngstadaas SP, Haugen HJ. Xenohybrid Bone Graft Containing Intrinsically Disordered Proteins Shows Enhanced In Vitro Bone Formation. ACS Appl Bio Mater. 2020 Apr 20;3(4):2263-2274. doi: 10.1021/acsabm.0c00064. Epub 2020 Mar 13.

    PubMed 35025278

  • Ovrebo O, Lyngstadaas SP, El Khassawna T, Jamous R, Ma Q, Munoz F, Permuy M, Cantalapiedra AG, Serrano-Munoz AJ, Ramis JM, Monjo M, Rossi F, Haugen HJ. Multiomics Comparison of Proline-Rich Peptide-Enhanced Hyaluronic Acid Gels Versus Conventional Regenerative Materials: An Early Wound-Healing Model. J Periodontal Res. 2025 Oct;60(10):1018-1038. doi: 10.1111/jre.70032. Epub 2025 Sep 10.

    PubMed 40928114

  • Villa O, Wohlfahrt JC, Mdla I, Petzold C, Reseland JE, Snead ML, Lyngstadaas SP. Proline-Rich Peptide Mimics Effects of Enamel Matrix Derivative on Rat Oral Mucosa Incisional Wound Healing. J Periodontol. 2015 Dec;86(12):1386-95. doi: 10.1902/jop.2015.150207. Epub 2015 Aug 7.

    PubMed 26252748

  • Saiz AM, Rahmati M, Johnson SD, Bhat AS, Baldini TD, Ovrebo O, Nogueira LP, Khassawna TE, Stotzel S, Fierro FA, Lee MA, Leach JK, Haugen HJ. Systemic versus local delivery of mesenchymal stem cells to improve the early stages of fracture healing in a polytrauma model. J Biol Eng. 2025 Sep 30;19(1):82. doi: 10.1186/s13036-025-00554-4.

    PubMed 41029699

  • Saiz AM, Rahmati M, Baldini TD, Satish Bhat A, Johnson SD, Liu M, Reyes RM, Fok SW, Lee MA, El Khassawna T, Wieland DCF, Marinho AL, Blanchet C, Leach JK, Haugen HJ. Mesenchymal stem cells delivered via a bioactive disordered peptide-hydrogel platform modulate early inflammation and enhance skeletal repair in a polytrauma model. J Tissue Eng. 2025 Dec 1;16:20417314251397106. doi: 10.1177/20417314251397106. eCollection 2025 Jan-Dec.

    PubMed 41340773

  • Lyngstadaas SP, Wohlfahrt JC, Brookes SJ, Paine ML, Snead ML, Reseland JE. Enamel matrix proteins; old molecules for new applications. Orthod Craniofac Res. 2009 Aug;12(3):243-53. doi: 10.1111/j.1601-6343.2009.01459.x.

    PubMed 19627527

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Hydrogel in people with Periodontal Disease and Intrabony Periodontal Defects, run by Siddharth Shanbhag at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Siddharth V Shanbhag, Ph.D. (+4740041647, siddhars@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CAL change (time frame: 6 and 12 months after periodontal regenerative surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07581613, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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