A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients (PERIHEAL)
11. maj 2026 opdateret af: 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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Siddharth V Shanbhag, Ph.D.
- Telefonnummer: +4740041647
- E-mail: siddhars@uio.no
Undersøgelse Kontakt Backup
- Navn: Anders Verket, Ph.D.
- Telefonnummer: +4722852064
- E-mail: anderver@odont.uio.no
Studiesteder
-
-
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Oslo, Norge, 0455
- Faculty of Dentistry, University of Oslo
-
Kontakt:
- Siddharth V Shanbhag, Ph.D.
- Telefonnummer: +4740041647
- E-mail: siddhars@uio.no
-
-
-
-
-
Madrid, Spanien
- Faculty of Dentistry, University Complutense of Madrid
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Kontakt:
- Mariano Sanz, Ph.D.
- Telefonnummer: +34913942021
- E-mail: marsan@ucm.es
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Peptide hydrogel
Peptide hydrogel with a proprietary root conditioning/cleaning agent
|
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.
Andre navne:
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)
Andre navne:
|
|
Aktiv komparator: Hyaluronic acid hygrodel
Hyaluronic acid hydrogel with a proprietary root conditioning/cleaning agent
|
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.
Andre navne:
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)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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CAL change
Tidsramme: 6 and 12 months after periodontal regenerative surgery
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Changes in Clinical Attachment Level (CAL) of the treated teeth
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6 and 12 months after periodontal regenerative surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MBL change
Tidsramme: 6 and 12 months after regenerative periodontal surgery
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Changes in radiographic Marginal Bone Level (MBL)
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6 and 12 months after regenerative periodontal surgery
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Gingival Healing Index (GHI)
Tidsramme: 7 and 14 days after periodontal regenerative surgery
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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.
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7 and 14 days after periodontal regenerative surgery
|
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Proteomic analysis of gingival crevicular fluid (GCF)
Tidsramme: 7, 14 and 30 days after regenerative surgery
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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.
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7, 14 and 30 days after regenerative surgery
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Oral health related quality of life
Tidsramme: 6 and 12 months after regenerative surgery
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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.
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6 and 12 months after regenerative surgery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Siddharth Shanbhag, Ph.D., University of Oslo
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. november 2026
Primær færdiggørelse (Anslået)
30. juni 2029
Studieafslutning (Anslået)
30. juni 2030
Datoer for studieregistrering
Først indsendt
27. april 2026
Først indsendt, der opfyldte QC-kriterier
5. maj 2026
Først opslået (Faktiske)
12. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PERIHEAL
Plan for individuelle deltagerdata (IPD)
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