Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects

ConditionsPeriodontal Bone Loss Periodontal Defect Periodontitis Stage III Periodontitis Stage IV

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss® graft
Procedure/Surgery
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/Surgery
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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss®Experimental treatment 1 intervention

Group B: Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss®Active comparator 1 intervention

Trial outcomes

Primary outcomes

Clinical Attachment Level

Measured as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket using a calibrated periodontal probe (PCP-UNC 15). Measurements will be recorded at six sites per tooth. Changes in CAL from baseline to 12 months, 3 years, and 5 years will be used to assess periodontal regeneration and treatment effectiveness.

Time frame

Baseline, 12 months, 3 years, and 5 years after surgery

Secondary outcomes

Probing Pocket Depth

Probing Pocket Depth (PPD) will be measured as the distance from the gingival margin to the base of the periodontal pocket using a calibrated periodontal probe (PCP-UNC 15). Measurements will be taken at six sites per tooth. Changes in PPD from baseline to follow-up visits will be used to assess periodontal healing and reduction of periodontal pocket depth.

Time frame

Baseline, 12 months, 3 years, and 5 years post-surgery

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shashi Dadlani

Lead sponsor

Clinica Dadlani

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: