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OpenTrials
Completed

NCT Number: NCT07230522

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®)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Sofia, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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 + Emdogain

Biological

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

Primary outcomes

  1. periodontal pocket depth reduction

    Time frame: Before the surgery and 6 moths after the surgery

  2. Clinical attachment gain

    Time frame: Before the surgery and 6 months after surgery

  3. Radiographic bone fill

    Time frame: Before and 6 months after surgery.

Sponsors and collaborators

Lead sponsor

Medical University of Sofia

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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