Effectiveness of Hyaluronic Acid (hyaDENT BG® Gel) Compared With Enamel Matrix Proteins (Emdogain®) in the Treatment of Angular Bone Defects in Combination With a Xenograft (Bio-Oss Collagen®)

November 13, 2025 updated by: Hristina Maynalovska, Medical University of Sofia

The goal of this clinical trial is to learn whether hyaluronic acid (HyaDent® BG) provides similar benefits to Emdogain® when both are used with Bio-Oss® Collagen during periodontal surgery in adults with periodontal (intrabony) defects. The main questions it aims to answer are:

Does the treatment reduce probing pocket depth?

Does the treatment increase clinical attachment level?

Does the treatment increase radiographic bone fill?

Does the treatment change the gingival margin position?

Researchers will compare Bio-Oss Collagen + HyaDent BG with Bio-Oss Collagen + Emdogain to see whether HyaDent BG achieves similar improvements in clinical and radiographic outcomes as Emdogain.

Participants will:

Undergo periodontal surgery to treat the vertical bone defect(s), with either Bio-Oss Collagen + HyaDent BG or Bio-Oss Collagen + Emdogain.

Attend follow-up visits for periodontal measurements and radiographs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

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 Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Departement of Periodontology, Faculty of Dental Medicine, Medical University of Sofia

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 over the age of 18 diagnosed with periodontal disease-Stage III or IV periodontitis;

    • Sites with bone defects and a probing pocket depth (PPD) ≥ 6 mm, accompa-nied by bleeding on probing (BoP) at re-evaluation, conducted six weeks after non-surgical periodontal therapy;
    • Full Mouth Plaque Score (FMPS) < 20% and Full Mouth Bleeding Score (FMBS) < 15% prior to surgical treatment;
    • Good general health with no systemic conditions and no known allergies to materials or medications used in the study.

Exclusion Criteria:

  • Medical conditions contraindicating surgical intervention;

    • Pregnancy or lactation;
    • Heavy smokers;
    • Untreated periodontal disease;
    • Poor oral hygiene;
    • Acute infectious lesions in the area of intervention;

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bio-Oss Collagen + HyaDent BG
Periodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with HyaDent® BG (cross-linked hyaluronic acid gel). The procedure follows standard periodontal surgical protocols.
Biological: Bio-Oss Collagen + HyaDent BG
Application of Bio-Oss® Collagen combined with HyaDent® BG (cross-linked hyaluronic acid gel) during periodontal surgery for intrabony defects. Standard regenerative protocols are followed.
Active Comparator: Bio-Oss Collagen + Emdogain
Periodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with Emdogain®. The procedure follows standard periodontal surgical protocols.
Biological: Bio-Oss Collagen + Emdogain
Application of Bio-Oss® Collagen combined with Emdogain during periodontal surgery for intrabony defects. Standard regenerative protocols are followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
periodontal pocket depth reduction
Time Frame: Before the surgery and 6 moths after the surgery
Before the surgery and 6 moths after the surgery
Clinical attachment gain
Time Frame: Before the surgery and 6 months after surgery
Before the surgery and 6 months after surgery
Radiographic bone fill
Time Frame: Before and 6 months after surgery.
Before and 6 months after surgery.

Collaborators and Investigators

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

Sponsor

Medical University of Sofia

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 (Actual)

March 12, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUS-D304-HA-EMD-001
  • Agreement No. D 304/18.12.2023 (Other Grant/Funding Number: Medical University of Sofia)

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.

Clinical Trials on Periodontitis

Clinical Trials on Bio-Oss Collagen + HyaDent BG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe