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®)

NCT07230522 | Completed

• 2 other identifiers: MUS-D304-HA-EMD-001Agreement No. D 304/18.12.2023
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Periodontitis; Intrabony Periodontal Defect; Periodontal Bone Loss

Keywords

periodontal regeneration; hyaluronic acid; enamel matrix derivative; angular bone defects

Outcome Measures

Primary Outcomes (3)

• periodontal pocket depth reduction

  Before the surgery and 6 moths after the surgery

• Clinical attachment gain

  Before the surgery and 6 months after surgery

• Radiographic bone fill

  Before and 6 months after surgery.

Study Arms (2)

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.

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.

Biological: Bio-Oss Collagen + Emdogain

Interventions

Bio-Oss Collagen + HyaDent BG BIOLOGICAL

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 + HyaDent BG

Bio-Oss Collagen + Emdogain BIOLOGICAL

Application of Bio-Oss® Collagen combined with Emdogain during periodontal surgery for intrabony defects. Standard regenerative protocols are followed.

Bio-Oss Collagen + Emdogain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Sofia: lead

Study Sites (1)

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

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Periodontitis; Alveolar Bone Loss

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Assistant

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: March 12, 2024
• Primary Completion: July 31, 2024
• Study Completion: January 10, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)