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Periodontal infrabony defects treatment with bone grafts mixed with Emdogain vs. mixed with cross-linked hyaluronic acid

Clinical outcomes after treatment of infrabony defects with bone grafts mixed with cross-linked hyaluronic acid or enamel matrix derivative: a 12-month randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68819973
Enrollment
60
Registered
2024-10-28
Start date
2024-10-23
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical regenerative treatment of infrabony periodontal defects Oral Health

Interventions

In patients who completed steps 1 and 2 of periodontal therapy but failed to achieve the endpoints of therapy (no periodontal pockets >4 mm with bleeding on probing or no deep periodontal pockets =6 m

Sponsors

Victor Babe? University of Medicine and Pharmacy Timi?oara
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years with periodontitis Stage II-IV 2. Presence of at least one infrabony defect of at least 4mm in depth 3. No systemic conditions affecting periodontal healing 4. Non-smokers/smoking up to 8 cigarettes a day

Exclusion criteria

Exclusion criteria: 1. Horizontal defects 2. Pregnancy or lactation 3. Allergies to study materials 4. Smoking more than 10 cigarettes/ day

Design outcomes

Primary

MeasureTime frame
Clinical attachment level (CAL) gain measured using calibrated periodontal probe (PCP-UNC15 HuFriedy )with a consistent reference point (CEJ) at 6- and 12-months post-surgery

Secondary

MeasureTime frame
1. Probing depth (PD) is measured using a calibrated manual periodontal probe with measurements taken at six sites per tooth at baseline, 6 months, and 12 months post-surgery 2. Reduction of BOP is measured using the calculated percentage of sites with BOP (BOP Percentage = Total number of sites probed / Number of sites with bleeding × 100) at baseline, 6 months, and 12 months post-surgery 3. Radiographic bone fill is measured using Linear Bone Fill Measurements at 6 months and 12 months post-surgery 4. Gingival recession is measured using direct clinical measurements with a periodontal probe from the CEJ to the free gingival margin at baseline, 6 months, and 12 months 5. Post-operative pain is measured using the Visual Analog Scale (VAS) at immediately post-op (within 2-4 hours), Day 1 (24 hours post-surgery), Day 3 (72 hours post-surgery), Day 7 (1 week post-surgery), Day 14, and 1 month for delayed pain assessment

Countries

Romania

Contacts

Public ContactMeizi Eliezer
meizi.eliezer@gmail.com+972522577260

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026