Intrabony Periodontal Defect
Conditions
Brief summary
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
PROCEDUREEntire 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.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
DRUGEnamel Matrix Derivative (EMD)- Emdogain
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.
OTHERBone substitute - Bio Oss Collagen
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level gain (CAL, mm) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth (PPD, mm) | 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. |
| Probing Pocket Depth reduction (PPD, mm) | 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. |
| Clinical Attachment Level (CAL, mm) | 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. |
| Gingival Recession (GR, mm) | 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. |
| Keratinized Tissue Width (KTW, mm) | Baseline, 6 months and 12 months | 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. |
| Gingival Thickness (GT, mm) | Baseline, 6 months and 12 months | 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. |
| Soft Tissue Volumetric Change (mm³) | 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. |
| Radiographic Linear Defect Fill (LDF, mm) | 6 months and 12 months | Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points. |
| Radiographic Percentage Defect Fill (%DF) | 6 months and 12 months | 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. |
| Early Wound Healing Score (EHS) | 1 week and 2 weeks | 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. |
| Full-Mouth Plaque Score (FMPS, %) | Baseline, 6 months, and 12 months | Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%). |
| Full-Mouth Bleeding Score (FMBS, %) | Baseline, 6 months, and 12 months | Percentage of tooth surfaces with bleeding on probing, assessed using a standardized method and expressed as a percentage (%). |
Countries
Poland
Contacts
CONTACTMałgorzata Wyszyńska-Pomian
CONTACTBartłomiej Górski
STUDY_CHAIRBartłomiej Górski
Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Outcome results
None listed