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Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.

28 juillet 2026 mis à jour par: Medical University of Warsaw
This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This randomized controlled clinical trial aims to evaluate the clinical, radiographic, and volumetric outcomes of periodontal regenerative treatment using the Entire Papilla Preservation Technique (EPPT) with or without the addition of a subepithelial connective tissue graft (SCTG) in the treatment of intrabony periodontal defects.

Patients will be randomly assigned to receive EPPT combined with enamel matrix derivative (EMD) either with or without SCTG. Clinical, radiographic, and digital volumetric parameters will be assessed at baseline, 6 months, and 12 months to evaluate treatment outcomes.

Exploratory analyses will be conducted to assess the relationship between selected genetic polymorphisms (NLRP2 and IL-1β) and clinical outcomes of periodontal regeneration, including clinical attachment level, probing pocket depth, and gingival recession.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

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

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Pologne
      • Bialystok, Pologne, 15276
        • Department of Integrated Dentistry, University of Białystok
        • Contact:
      • Szczecin, Pologne
        • Department of Periodontology, Pomeranian Medical University Contact
        • Contact:
    • Warsaw
      • Warsaw, Warsaw, Pologne, 00-246
        • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

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:

  • Age ≥ 18 years,
  • Good compliance and good oral hygiene
  • Systemically healthy
  • Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph
  • The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.

Exclusion Criteria:

  • Full-mouth plaque score ≥ 20% (O'Leary et al 1972)
  • Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)
  • Smoking
  • Systemic diseases that would adversely influence wound healing
  • Medications interfering with post-operative wound healing
  • Pregnant and lactating females
  • Previous periodontal surgery in the examined area
  • III-degree mobility
  • Furcation involvement
  • Pulpal pathology or inadequate endodontic treatment

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
Comparateur actif: Entire Papilla Preservation Technique (EPPT) + EMD
Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material as needed. Flaps are repositioned and sutured for primary closure.
Procédure: Entire Papilla Preservation Technique (EPPT)
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla. The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Autre: EDTA root conditioning
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
Médicament: Enamel Matrix Derivative (EMD)- Emdogain
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
Autre: Bone substitute - Bio Oss Collagen
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Expérimental: Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG
Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD) and subepithelial connective tissue graft (SCTG). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material. A subepithelial connective tissue graft is harvested and placed at the defect site prior to flap closure.
Procédure: Entire Papilla Preservation Technique (EPPT)
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla. The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Autre: EDTA root conditioning
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
Médicament: Enamel Matrix Derivative (EMD)- Emdogain
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
Autre: Bone substitute - Bio Oss Collagen
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Procédure: Subepithelial Connective Tissue Graft (SCTG)
An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Clinical Attachment Level gain (CAL, mm)
Délai: 6 months and 12 months
Clinical Attachment Level (CAL) gain, measured in millimeters (mm), defined as the change from baseline in the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
6 months and 12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Probing Pocket Depth (PPD, mm)
Délai: Baseline, 6 months and 12 months
Probing Pocket Depth (PPD), measured in millimeters (mm), defined as the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
Baseline, 6 months and 12 months
Probing Pocket Depth reduction (PPD, mm)
Délai: 6 months and 12 months
Probing Pocket Depth (PPD) reduction, measured in millimeters (mm), defined as the change from baseline in the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
6 months and 12 months
Clinical Attachment Level (CAL, mm)
Délai: Baseline, 6 months, and 12 months
Clinical Attachment Level (CAL), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
Baseline, 6 months, and 12 months
Gingival Recession (GR, mm)
Délai: Baseline, 6 months and 12 months
Gingival recession (GR), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the gingival margin, assessed using a calibrated periodontal probe.
Baseline, 6 months and 12 months
Keratinized Tissue Width (KTW, mm)
Délai: Baseline, 6 months and 12 months
Keratinized tissue width (KTW), measured in millimeters (mm), defined as the distance from the gingival margin to the mucogingival junction, assessed using a periodontal probe.
Baseline, 6 months and 12 months
Gingival Thickness (GT, mm)
Délai: Baseline, 6 months and 12 months
Gingival thickness (GT), measured in millimeters (mm) at the buccal aspect 3 mm apical to the gingival margin using a standardized transgingival probing method with an endodontic file and stopper.
Baseline, 6 months and 12 months
Soft Tissue Volumetric Change (mm³)
Délai: 6 months and 12 months
Change from baseline in soft tissue volume, expressed in cubic millimeters (mm³), assessed by superimposition of digital intraoral scans (STL files) using dedicated software with standardized reference areas.
6 months and 12 months
Radiographic Linear Defect Fill (LDF, mm)
Délai: 6 months and 12 months
Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points.
6 months and 12 months
Radiographic Percentage Defect Fill (%DF)
Délai: 6 months and 12 months
Percentage defect fill (%DF), expressed as a percentage (%), calculated based on standardized measurements obtained from periapical radiographs using a reproducible measurement protocol to assess bone defect resolution.
6 months and 12 months
Early Wound Healing Score (EHS)
Délai: 1 week and 2 weeks
Early wound healing will be assessed using the Early Wound Healing Score (EHS), a composite clinical index ranging from 0 to 10 based on re-epithelialization, hemostasis, and inflammation, with higher scores indicating better healing.
1 week and 2 weeks
Full-Mouth Plaque Score (FMPS, %)
Délai: Baseline, 6 months, and 12 months
Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%).
Baseline, 6 months, and 12 months
Full-Mouth Bleeding Score (FMBS, %)
Délai: Baseline, 6 months, and 12 months
Percentage of tooth surfaces with bleeding on probing, assessed using a standardized method and expressed as a percentage (%).
Baseline, 6 months, and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Medical University of Warsaw

Les enquêteurs

  • Chaise d'étude: Bartłomiej Górski, Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

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 août 2026

Achèvement primaire (Estimé)

30 septembre 2027

Achèvement de l'étude (Estimé)

30 novembre 2027

Dates d'inscription aux études

Première soumission

2 avril 2026

Première soumission répondant aux critères de contrôle qualité

28 juillet 2026

Première publication (Réel)

30 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2026

Dernière vérification

1 janvier 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Perio.06

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

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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