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

NCT05541614 NA UNKNOWN

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.

Details

Lead sponsor	Aristotle University Of Thessaloniki
Phase	NA
Status	UNKNOWN
Enrolment	44
Start date	Sat Oct 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

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

Interventions

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

Countries

Greece