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

NCT07589959 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-15

No results posted yet for this study

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

Conditions

  • Periodontal Bone Loss
  • Periodontal Defect
  • Periodontitis Stage III
  • Periodontitis Stage IV

Interventions

PROCEDURE

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

PROCEDURE

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

Sponsors & Collaborators

  • Shashi Dadlani

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2031-05-22
Completion
2031-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07589959 on ClinicalTrials.gov