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 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Małgorzata Wyszyńska-Pomian
- Telefonnummer: +48 504006984
- E-post: malgorzata.wyszynska@wum.edu.pl
Studera Kontakt Backup
- Namn: Bartłomiej Górski
- Telefonnummer: +48221166431
- E-post: bartlomiej.gorski@wum.edu.pl
Studieorter
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Bialystok, Polen, 15276
- Department of Integrated Dentistry, University of Białystok
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Kontakt:
- Anna Skurska
- E-post: annaskurska@wp.pl
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Szczecin, Polen
- Department of Periodontology, Pomeranian Medical University Contact
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Kontakt:
- Monika Machoy
- E-post: 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical Attachment Level gain (CAL, mm)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Probing Pocket Depth (PPD, mm)
Tidsram: Baseline, 6 months and 12 months
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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
|
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Probing Pocket Depth reduction (PPD, mm)
Tidsram: 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.
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6 months and 12 months
|
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Clinical Attachment Level (CAL, mm)
Tidsram: 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
|
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Gingival Recession (GR, mm)
Tidsram: Baseline, 6 months and 12 months
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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)
Tidsram: 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.
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Baseline, 6 months and 12 months
|
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Gingival Thickness (GT, mm)
Tidsram: 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)
Tidsram: 6 months and 12 months
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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)
Tidsram: 6 months and 12 months
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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)
Tidsram: 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)
Tidsram: 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, %)
Tidsram: Baseline, 6 months, and 12 months
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Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%).
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Baseline, 6 months, and 12 months
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Full-Mouth Bleeding Score (FMBS, %)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Bartłomiej Górski, Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
30 september 2027
Avslutad studie (Beräknad)
30 november 2027
Studieregistreringsdatum
Först inskickad
2 april 2026
Först inskickad som uppfyllde QC-kriterierna
28 juli 2026
Första postat (Faktisk)
30 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juli 2026
Senast verifierad
1 januari 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Perio.06
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