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NCT Number: NCT07737834

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

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.

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Key information

Conditions

Intrabony Periodontal Defect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw, Warsaw, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entire Papilla Preservation Technique (EPPT)

Procedure

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.

EDTA root conditioning

Other

Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.

Enamel Matrix Derivative (EMD)- Emdogain

Drug

A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.

Subepithelial connective tissue graft (SCTG)

Procedure

An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.

Bone substitute - Bio Oss Collagen

Other

A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.

Primary outcomes

  1. Clinical Attachment Level gain (CAL, mm)

    Time frame: 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 outcomes

  1. Probing Pocket Depth (PPD, mm)

    Time frame: 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.

  2. Probing Pocket Depth reduction (PPD, mm)

    Time frame: 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.

  3. Clinical Attachment Level (CAL, mm)

    Time frame: 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.

  4. Gingival Recession (GR, mm)

    Time frame: 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.

  5. Keratinized Tissue Width (KTW, mm)

    Time frame: 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.

  6. Gingival Thickness (GT, mm)

    Time frame: 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.

  7. Soft Tissue Volumetric Change (mm³)

    Time frame: 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.

  8. Radiographic Linear Defect Fill (LDF, mm)

    Time frame: 6 months and 12 months

    Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points.

  9. Radiographic Percentage Defect Fill (%DF)

    Time frame: 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.

  10. Early Wound Healing Score (EHS)

    Time frame: 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.

  11. Full-Mouth Plaque Score (FMPS, %)

    Time frame: Baseline, 6 months, and 12 months

    Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%).

  12. Full-Mouth Bleeding Score (FMBS, %)

    Time frame: Baseline, 6 months, and 12 months

    Percentage of tooth surfaces with bleeding on probing, assessed using a standardized method and expressed as a percentage (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Bartłomiej Górski

CONTACT

[email protected]

+48221166431

Małgorzata Wyszyńska-Pomian

CONTACT

[email protected]

+48 504006984

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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