A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients (PERIHEAL)
11 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Siddharth V Shanbhag, Ph.D.
- Numéro de téléphone: +4740041647
- E-mail: siddhars@uio.no
Sauvegarde des contacts de l'étude
- Nom: Anders Verket, Ph.D.
- Numéro de téléphone: +4722852064
- E-mail: anderver@odont.uio.no
Lieux d'étude
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Madrid, Espagne
- Faculty of Dentistry, University Complutense of Madrid
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Contact:
- Mariano Sanz, Ph.D.
- Numéro de téléphone: +34913942021
- E-mail: marsan@ucm.es
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Oslo, Norvège, 0455
- Faculty of Dentistry, University of Oslo
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Contact:
- Siddharth V Shanbhag, Ph.D.
- Numéro de téléphone: +4740041647
- E-mail: siddhars@uio.no
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Peptide hydrogel
Peptide hydrogel with a proprietary root conditioning/cleaning agent
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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.
Autres noms:
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)
Autres noms:
|
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Comparateur actif: 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.
Autres noms:
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)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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CAL change
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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MBL change
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Siddharth Shanbhag, Ph.D., University of Oslo
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 novembre 2026
Achèvement primaire (Estimé)
30 juin 2029
Achèvement de l'étude (Estimé)
30 juin 2030
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PERIHEAL
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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