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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 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Procedure: 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.
Ander: EDTA root conditioning
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
Geneesmiddel: Enamel Matrix Derivative (EMD)- Emdogain
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
Ander: Bone substitute - Bio Oss Collagen
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Experimenteel: 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.
Procedure: 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.
Ander: EDTA root conditioning
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
Geneesmiddel: Enamel Matrix Derivative (EMD)- Emdogain
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
Ander: Bone substitute - Bio Oss Collagen
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical Attachment Level gain (CAL, mm)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Probing Pocket Depth (PPD, mm)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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, %)
Tijdsspanne: 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, %)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medical University of Warsaw

Onderzoekers

  • Studie stoel: Bartłomiej Górski, Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

30 september 2027

Studie voltooiing (Geschat)

30 november 2027

Studieregistratiedata

Eerst ingediend

2 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juli 2026

Eerst geplaatst (Werkelijk)

30 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

28 juli 2026

Laatst geverifieerd

1 januari 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Perio.06

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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