Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects (PN-HAVSEMPIND)

May 11, 2026 updated by: Shashi Dadlani

Polynucleotides and Hyaluronic Acid vs Enamel Matrix Derivative Proteins in the Treatment of Intrabony Defects: A Randomized Controlled Clinical 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical study evaluates two regenerative approaches used during minimally invasive periodontal surgery for the treatment of infrabony periodontal defects deeper than 3 mm. The study compares a combination of hyaluronic acid and polynucleotides (Regenfast®) with enamel matrix derivative proteins (Emdogain®), both used together with a bovine bone graft material (Bio-Oss®).

This is a randomized, multicenter clinical study conducted in three specialized periodontal clinics by experienced periodontists. Adults with Stage III or IV periodontitis who continue to have deep periodontal defects after initial periodontal treatment may be eligible to participate.

Participants will first receive standard non-surgical periodontal treatment, including professional cleaning, root planing, oral hygiene instruction, and chlorhexidine mouth rinses. Eight weeks later, a clinical and radiographic reevaluation will be performed. Patients who meet the study criteria will undergo minimally invasive periodontal surgery using papilla preservation techniques.

During surgery, the periodontal defect will be cleaned and treated with one of the two regenerative materials selected randomly through a sealed-envelope allocation process. Patients will receive either Regenfast® with Bio-Oss® or Emdogain® with Bio-Oss®. All participants will receive local anesthesia, postoperative antibiotics, pain medication, and supportive periodontal care.

Researchers will monitor healing and treatment outcomes through clinical examinations and radiographic evaluations performed at 1 year, 3 years, and 5 years after surgery. Measurements will include periodontal pocket depth, gum recession, clinical attachment level, bleeding on probing, tooth mobility, and the amount of bone regeneration seen on radiographs. The study will also evaluate long-term tooth survival and analyze whether factors such as smoking habits or defect shape influence treatment outcomes.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Periodontal pocket depth ≥ 6 mm at baseline (after initial treatment)
  • Full-mouth plaque and bleeding scores ≤ 20%, ≤15% at re-evaluation
  • Ability and willingness to attend follow-up visits for 1, 3, and 5 years
  • Teeth included in the study must be healthy from an endodontic point of view or properly root-treated

Exclusion Criteria:

  • 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%
  • Current alcohol or drug abuse
  • Patients who have received periodontal treatment within the last 6 months
  • Patients unwilling or unable to attend follow-up visits required for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss®
Name: Regenfast® + Bio-Oss® Intervention: Hyaluronic acid + polynucleotides (Regenfast®) combined with bovine bone graft (Bio-Oss®) Procedure: Applied during minimally invasive periodontal regenerative surgery
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
Active Comparator: Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss®
Name: Emdogain® + Bio-Oss® Intervention: Enamel matrix derivative proteins (Emdogain®) combined with bovine bone graft (Bio-Oss®) Procedure: Applied during minimally invasive periodontal regenerative surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level
Time Frame: Baseline, 12 months, 3 years, and 5 years after surgery
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.
Baseline, 12 months, 3 years, and 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Pocket Depth
Time Frame: Baseline, 12 months, 3 years, and 5 years post-surgery
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.
Baseline, 12 months, 3 years, and 5 years post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shashi Dadlani

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 22, 2031

Study Completion (Estimated)

July 30, 2031

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26042703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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