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®)

Medical University of Sofia

Status: Completed

Conditions: Periodontitis; Intrabony Periodontal Defect; Periodontal Bone Loss

Treatments: Biological: Bio-Oss Collagen + Emdogain; Biological: Bio-Oss Collagen + HyaDent BG

Study type: Interventional

Funder types: Other

Identifiers

NCT07230522

Agreement No. D 304/18.12.2023 (Other Grant/Funding Number)

MUS-D304-HA-EMD-001

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Bio-Oss Collagen + HyaDent BG

Experimental group

Description:

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.

Treatment:

Biological: Bio-Oss Collagen + HyaDent BG

Bio-Oss Collagen + Emdogain

Active Comparator group

Description:

Periodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with Emdogain®. The procedure follows standard periodontal surgical protocols.

Treatment:

Biological: Bio-Oss Collagen + Emdogain