Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShashi Dadlani
About this trial
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
Eligibility criteria
Qualifiers
Adults aged 18 years or older
Non-smokers or light smokers (fewer than 10 cigarettes per day)
No diabetes or well-controlled diabetes
At least one infrabony periodontal defect ≥ 3 mm in depth
Disqualifiers
Pregnant or breastfeeding women
Patients with weakened immune systems or significant systemic diseases
Heavy smokers (more than 10 cigarettes per day)
Full-mouth plaque or bleeding scores >20%, >15%
Trial design
Treatments tested in this trial
- Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss® graft
- Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss® graft
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Shashi Dadlani
Lead sponsor
Clinica Dadlani
Sponsor institution
Source ClinicalTrials.gov