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Flapless Application of Enamel Matrix Derivative in Class II Mandibular Furcation Defects

NCT05541614 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-03-07

No results posted yet for this study

Summary

Patients diagnosed with stage III or IV periodontitis that exhibit mandibular first or second molars with increased periodontal probing depth (PPD \> 4 mm) and class II buccal mandibular furcation defects (horizontal probing depth of \>= 3 mm ) will be recruited. This study will be a non-inferiority, prospective, randomized, double-blind controlled clinical trial with a parallel design. Patient will be recruited from the clinics of the School of Dentistry at the Aristotle University of Thessaloniki and private dental practices in Thessaloniki, Greece. Initially, non-surgical periodontal treatment will be performed through scaling and root planning in combination with oral hygiene instructions and motivation. The re-evaluation will be performed 4-6 weeks following the treatment and the patients who meet the inclusion criteria will be included in the study. Patients will be randomly allocated at a 1:1 ratio to either subgingival debridement and flapless application of EMD (test group) into the affected furcation defect or to periodontal surgery in combination with EMD application (control group). Periodontal and radiographic parameters, patient reported outcomes, oral cavity measurements and gingival crevicular fluid will be collected before as well as up to 9 months following the treatment.

Conditions

  • Periodontal Diseases
  • Periodontal Disease, AVDC Stage 3
  • Periodontal Disease, AVDC Stage 4
  • Furcation Defects

Interventions

OTHER

Emdogain® FL (flapless Emdogain®) - Enamel Matrix Derivative

Emdogain® FL has been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.

OTHER

Emdogain® - Enamel Matrix Derivative

Enamel matrix derivative (EMD) has been widely used in the surgical treatment of periodontal disease and in furcation defects.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05541614 on ClinicalTrials.gov