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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 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: 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.
Altro: EDTA root conditioning
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
Droga: Enamel Matrix Derivative (EMD)- Emdogain
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
Altro: Bone substitute - Bio Oss Collagen
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Sperimentale: 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.
Procedura: 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.
Altro: EDTA root conditioning
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
Droga: Enamel Matrix Derivative (EMD)- Emdogain
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
Altro: Bone substitute - Bio Oss Collagen
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinical Attachment Level gain (CAL, mm)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Probing Pocket Depth (PPD, mm)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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, %)
Lasso di tempo: 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, %)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medical University of Warsaw

Investigatori

  • Cattedra di studio: Bartłomiej Górski, Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 settembre 2027

Completamento dello studio (Stimato)

30 novembre 2027

Date di iscrizione allo studio

Primo inviato

2 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 luglio 2026

Primo Inserito (Effettivo)

30 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 luglio 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Perio.06

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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