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

ConditionIntrabony Periodontal Defect
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Warsaw

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Entire Papilla Preservation Technique (EPPT)

    Procedure/Surgery

    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 intervention

    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/Surgery

    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 intervention

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Entire Papilla Preservation Technique (EPPT) + EMDActive comparator 4 interventions
Group B: Entire Papilla Preservation Technique (EPPT) + EMD+ SCTGExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Warsaw

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: