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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Другое EDTA root conditioning
  Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
• Препарат Enamel Matrix Derivative (EMD)- Emdogain
  A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
• Процедура 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.
• Другое Bone substitute - Bio Oss Collagen
  A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.

Первичные конечные точки

• Clinical Attachment Level gain (CAL, mm) [Срок оценки: 6 months and 12 months]

Вторичные конечные точки (12)

• Probing Pocket Depth (PPD, mm) [Срок оценки: Baseline, 6 months and 12 months]
• Probing Pocket Depth reduction (PPD, mm) [Срок оценки: 6 months and 12 months]
• Clinical Attachment Level (CAL, mm) [Срок оценки: Baseline, 6 months, and 12 months]
• Gingival Recession (GR, mm) [Срок оценки: Baseline, 6 months and 12 months]
• Keratinized Tissue Width (KTW, mm) [Срок оценки: Baseline, 6 months and 12 months]
• Gingival Thickness (GT, mm) [Срок оценки: Baseline, 6 months and 12 months]
• Soft Tissue Volumetric Change (mm³) [Срок оценки: 6 months and 12 months]
• Radiographic Linear Defect Fill (LDF, mm) [Срок оценки: 6 months and 12 months]
• Radiographic Percentage Defect Fill (%DF) [Срок оценки: 6 months and 12 months]
• Early Wound Healing Score (EHS) [Срок оценки: 1 week and 2 weeks]
• Full-Mouth Plaque Score (FMPS, %) [Срок оценки: Baseline, 6 months, and 12 months]
• Full-Mouth Bleeding Score (FMBS, %) [Срок оценки: Baseline, 6 months, and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Польша · 3 центра

• Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsa — Warsaw
• Department of Integrated Dentistry, University of Białystok — Bialystok
• Department of Periodontology, Pomeranian Medical University Contact — Szczecin

Идентификаторы

NCT: NCT07737834 · Perio.06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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