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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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