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 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Małgorzata Wyszyńska-Pomian
- Telefonnummer: +48 504006984
- E-mail: malgorzata.wyszynska@wum.edu.pl
Undersøgelse Kontakt Backup
- Navn: Bartłomiej Górski
- Telefonnummer: +48221166431
- E-mail: bartlomiej.gorski@wum.edu.pl
Studiesteder
-
-
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Bialystok, Polen, 15276
- Department of Integrated Dentistry, University of Białystok
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Kontakt:
- Anna Skurska
- E-mail: annaskurska@wp.pl
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Szczecin, Polen
- Department of Periodontology, Pomeranian Medical University Contact
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Kontakt:
- Monika Machoy
- E-mail: monika.machoy@pum.edu.pl
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-
Warsaw
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Warsaw, Warsaw, Polen, 00-246
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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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:
- 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
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 |
|---|---|
|
Aktiv komparator: 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.
|
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.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
|
|
Eksperimentel: 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.
|
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.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Attachment Level gain (CAL, mm)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Probing Pocket Depth (PPD, mm)
Tidsramme: 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.
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Baseline, 6 months and 12 months
|
|
Probing Pocket Depth reduction (PPD, mm)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
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Baseline, 6 months and 12 months
|
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Keratinized Tissue Width (KTW, mm)
Tidsramme: Baseline, 6 months and 12 months
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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
|
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Gingival Thickness (GT, mm)
Tidsramme: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
|
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Soft Tissue Volumetric Change (mm³)
Tidsramme: 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.
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6 months and 12 months
|
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Radiographic Linear Defect Fill (LDF, mm)
Tidsramme: 6 months and 12 months
|
Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points.
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6 months and 12 months
|
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Radiographic Percentage Defect Fill (%DF)
Tidsramme: 6 months and 12 months
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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.
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6 months and 12 months
|
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Early Wound Healing Score (EHS)
Tidsramme: 1 week and 2 weeks
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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.
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1 week and 2 weeks
|
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Full-Mouth Plaque Score (FMPS, %)
Tidsramme: 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, %)
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Bartłomiej Górski, Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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. august 2026
Primær færdiggørelse (Anslået)
30. september 2027
Studieafslutning (Anslået)
30. november 2027
Datoer for studieregistrering
Først indsendt
2. april 2026
Først indsendt, der opfyldte QC-kriterier
28. juli 2026
Først opslået (Faktiske)
30. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2026
Sidst verificeret
1. januar 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
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