CompletedNot Applicable

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®)

Bulgaria17 participantsStarted 2024-03-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

periodontal pocket depth reduction

Timeframe: Before the surgery and 6 moths after the surgery

Clinical attachment gain

Timeframe: Before the surgery and 6 months after surgery

Radiographic bone fill

Timeframe: Before and 6 months after surgery.

Trial details

NCT IDNCT07230522

SponsorMedical University of Sofia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31