NCT07581613

Brief 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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
45mo left

Started Nov 2026

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

April 27, 2026

Last Update Submit

May 11, 2026

Conditions

Periodontal DiseaseIntrabony Periodontal Defects

Keywords

periodontal regenerationhydrogels

Outcome Measures

Primary Outcomes (1)

  • CAL change

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

    6 and 12 months after periodontal regenerative surgery

Secondary Outcomes (4)

  • MBL change

    6 and 12 months after regenerative periodontal surgery

  • Gingival Healing Index (GHI)

    7 and 14 days after periodontal regenerative surgery

  • Oral health related quality of life

    6 and 12 months after regenerative surgery

  • Proteomic analysis of gingival crevicular fluid (GCF)

    7, 14 and 30 days after regenerative surgery

Study Arms (2)

Peptide hydrogel

EXPERIMENTAL

Peptide hydrogel with a proprietary root conditioning/cleaning agent

Biological: Hydrogel

Hyaluronic acid hygrodel

ACTIVE COMPARATOR

Hyaluronic acid hydrogel with a proprietary root conditioning/cleaning agent

Biological: Hydrogel

Interventions

HydrogelBIOLOGICAL

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.

Also known as: Proline-rich peptide hydrogel
Peptide hydrogel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry, University of Oslo

Oslo, 0455, Norway

Location

Faculty of Dentistry, University Complutense of Madrid

Madrid, Spain

Location

Related Publications (6)

  • 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.

    PMID: 35025278BACKGROUND

  • 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.

    PMID: 40928114BACKGROUND

  • 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.

    PMID: 26252748BACKGROUND

  • 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.

    PMID: 41029699BACKGROUND

  • 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.

    PMID: 41340773BACKGROUND

  • 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.

    PMID: 19627527BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Hydrogels

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GelsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Siddharth Shanbhag, Ph.D.

    University of Oslo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siddharth V Shanbhag, Ph.D.

CONTACT

+4740041647siddhars@uio.no

Anders Verket, Ph.D.

CONTACT

+4722852064anderver@odont.uio.no

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoctoral researcher

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 12, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2030

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations

NO(1)ES(1)