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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
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.
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Warsaw, Warsaw, Poland
Department of Integrated Dentistry, University of Białystok
Bialystok, Poland
Department of Periodontology, Pomeranian Medical University Contact
Szczecin, Poland
Clinical Attachment Level gain (CAL, mm)
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.
Time frame: 6 months and 12 months
Probing Pocket Depth (PPD, mm)
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.
Time frame: Baseline, 6 months and 12 months
Probing Pocket Depth reduction (PPD, mm)
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.
Time frame: 6 months and 12 months
Clinical Attachment Level (CAL, mm)
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.
Time frame: Baseline, 6 months, and 12 months
Gingival Recession (GR, mm)
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.
Time frame: Baseline, 6 months and 12 months
Keratinized Tissue Width (KTW, mm)
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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An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Time frame: Baseline, 6 months and 12 months
Gingival Thickness (GT, mm)
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.
Time frame: Baseline, 6 months and 12 months
Soft Tissue Volumetric Change (mm³)
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.
Time frame: 6 months and 12 months
Radiographic Linear Defect Fill (LDF, mm)
Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points.
Time frame: 6 months and 12 months
Radiographic Percentage Defect Fill (%DF)
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.
Time frame: 6 months and 12 months
Early Wound Healing Score (EHS)
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.
Time frame: 1 week and 2 weeks
Full-Mouth Plaque Score (FMPS, %)
Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%).
Time frame: Baseline, 6 months, and 12 months
Full-Mouth Bleeding Score (FMBS, %)
Percentage of tooth surfaces with bleeding on probing, assessed using a standardized method and expressed as a percentage (%).
Time frame: Baseline, 6 months, and 12 months