PeriodontitisNCT07230522
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®)
A study testing Bio-Oss Collagen + HyaDent BG and Bio-Oss Collagen + Emdogain in people with Periodontitis and Intrabony Periodontal Defect, run by Medical University of Sofia at 1 site in Bulgaria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Intrabony Periodontal Defect, Periodontal Bone Loss
- What is being tested?
- Bio-Oss Collagen + HyaDent BG and Bio-Oss Collagen + Emdogain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBulgaria
- Study dates
- 12 Mar 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Medical conditions contraindicating surgical intervention;
- Pregnancy or lactation;
- Heavy smokers;
- Untreated periodontal disease;
- Poor oral hygiene;
- Acute infectious lesions in the area of intervention;
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Departement of Periodontology, Faculty of Dental Medicine, Medical University of Sofia
Sofia
About this study
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?
Read more
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.
- Being tested
- Bio-Oss Collagen + HyaDent BG, Bio-Oss Collagen + Emdogain
- Keywords
- periodontal regeneration, hyaluronic acid, enamel matrix derivative, angular bone defects
- Medical subject headings
- Periodontitis, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-Oss Collagen + HyaDent BGBiological
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.
Bio-Oss Collagen + EmdogainBiological
Application of Bio-Oss® Collagen combined with Emdogain during periodontal surgery for intrabony defects. Standard regenerative protocols are followed.
| Study group | Role | What they receive |
|---|---|---|
| Bio-Oss Collagen + HyaDent BG | Experimental | 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. Receives: Biological: Bio-Oss Collagen + HyaDent BG |
| Bio-Oss Collagen + Emdogain | Active comparator | Periodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with Emdogain®. The procedure follows standard periodontal surgical protocols. Receives: Biological: Bio-Oss Collagen + Emdogain |
What is being measured
The primary outcome is the main question the study is designed to answer.
periodontal pocket depth reduction
Measured: Before the surgery and 6 moths after the surgery
Clinical attachment gain
Measured: Before the surgery and 6 months after surgery
Radiographic bone fill
Measured: Before and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start12 Mar 2024
- Primary completion31 Jul 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hristina Maynalovska, Medical University of Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230522
- Sponsor's protocol ID
- MUS-D304-HA-EMD-001
- Other IDs
- Agreement No. D 304/18.12.2023
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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®)
- ClinicalTrials.gov ID
- NCT07230522
- Acronym / sponsor ID
- MUS-D304-HA-EMD-001
- Keywords
- periodontal regeneration, hyaluronic acid, enamel matrix derivative, angular bone defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical University of SofiaUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-Oss Collagen + HyaDent BG | Experimental | Biological: Bio-Oss Collagen + HyaDent BGPeriodontal 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. |
| Bio-Oss Collagen + Emdogain | Active comparator | Biological: Bio-Oss Collagen + EmdogainPeriodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with Emdogain®. The procedure follows standard periodontal surgical protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over the age of 18 diagnosed with periodontal disease-Stage III or IV periodontitis;
Key exclusion criteria (6 listed)
- Medical conditions contraindicating surgical intervention;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-Oss Collagen + HyaDent BGApplication of Bio-Oss® Collagen combined with HyaDent® BG (cross-linked hyaluronic acid gel) during periodontal surgery for intrabony defects. Standard regenerative protocols are followed. | Biological | Bio-Oss Collagen + HyaDent BG |
| Bio-Oss Collagen + EmdogainApplication of Bio-Oss® Collagen combined with Emdogain during periodontal surgery for intrabony defects. Standard regenerative protocols are followed. | Biological | Bio-Oss Collagen + Emdogain |
Primary outcome
periodontal pocket depth reduction
Time frame: Before the surgery and 6 moths after the surgery
Clinical attachment gain
Time frame: Before the surgery and 6 months after surgery
Radiographic bone fill
Time frame: Before and 6 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-Oss Collagen + HyaDent BG and Bio-Oss Collagen + Emdogain in people with Periodontitis and Intrabony Periodontal Defect, run by Medical University of Sofia at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periodontal pocket depth reduction (time frame: Before the surgery and 6 moths after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.