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 range

18 Years

Sex

ALL

See this in plain English?

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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