Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Entire Papilla Preservation Technique (EPPT), EDTA root conditioning, Enamel Matrix Derivative (EMD)- Emdogain, Subepithelial Connective Tissue Graft (SCTG).
- Who it may be relevant to
- Registry conditions: Intrabony Periodontal Defect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- 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. - Other EDTA root conditioning
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes. - Drug Enamel Matrix Derivative (EMD)- Emdogain
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration. - 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. - Other Bone substitute - Bio Oss Collagen
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Primary outcome measures
- Clinical Attachment Level gain (CAL, mm) [Time frame: 6 months and 12 months]
Secondary outcome measures (12)
- Probing Pocket Depth (PPD, mm) [Time frame: Baseline, 6 months and 12 months]
- Probing Pocket Depth reduction (PPD, mm) [Time frame: 6 months and 12 months]
- Clinical Attachment Level (CAL, mm) [Time frame: Baseline, 6 months, and 12 months]
- Gingival Recession (GR, mm) [Time frame: Baseline, 6 months and 12 months]
- Keratinized Tissue Width (KTW, mm) [Time frame: Baseline, 6 months and 12 months]
- Gingival Thickness (GT, mm) [Time frame: Baseline, 6 months and 12 months]
- Soft Tissue Volumetric Change (mm³) [Time frame: 6 months and 12 months]
- Radiographic Linear Defect Fill (LDF, mm) [Time frame: 6 months and 12 months]
- Radiographic Percentage Defect Fill (%DF) [Time frame: 6 months and 12 months]
- Early Wound Healing Score (EHS) [Time frame: 1 week and 2 weeks]
- Full-Mouth Plaque Score (FMPS, %) [Time frame: Baseline, 6 months, and 12 months]
- Full-Mouth Bleeding Score (FMBS, %) [Time frame: Baseline, 6 months, and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Poland · 3 centers
- 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
Identifiers
NCT: NCT07737834 · Perio.06