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Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects
Sponsor: Shashi Dadlani
Summary
The goal of this clinical trial is to compare two periodontal regenerative treatments in adults with Stage III or IV periodontitis and infrabony periodontal defects ≥3 mm. The study aims to determine whether hyaluronic acid and polynucleotides (Regenfast®) combined with bovine bone graft material (Bio-Oss®) provides similar or improved periodontal regeneration compared with enamel matrix derivative proteins (Emdogain®) combined with Bio-Oss®. Researchers will evaluate: * Periodontal healing and bone regeneration * Changes in probing depth, clinical attachment level, gingival recession, and tooth mobility * Radiographic bone fill * Survival of treated teeth after 1, 3, and 5 years Participants will: * Receive initial periodontal treatment and oral hygiene instruction * Undergo clinical and radiographic evaluation * Receive minimally invasive periodontal regenerative surgery under local anesthesia * Be randomly assigned to receive either Regenfast® + Bio-Oss® or Emdogain® + Bio-Oss® * Attend follow-up visits with periodontal examinations and radiographs over 5 years
Official title: Polynucleotides and Hyaluronic Acid vs Enamel Matrix Derivative Proteins in the Treatment of Intrabony Defects: A Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-05
Completion Date
2031-07-30
Last Updated
2026-05-15
Healthy Volunteers
No
Interventions
Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss® graft
Combination Product: using PAPILLA Preservation Flap + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) REGENFAST+ Bio-Oss • A PNHA gel will be placed on the root surfaces and infra-bony defects, followed by a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps using 5-0 suture
Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss® graft
Procedure: Papilla Preservation Flap • A conservative access flap will be performed such as simplified papilla preservation flap (SPPF). Use of EDTA 24 %, EMDOGAIN AND BIO-OSS® suturing the flap by tension-free primary closure of the interdental papillae and of the mucoperiosteal using 5-0 suture