Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects (NCT07589959) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects
40 participantsStarted 2026-05
Plain-language summary
The goal of this clinical trial is to compare two periodontal regenerative treatments in adults with Stage III or IV periodontitis and infrabony periodontal defects ≥3 mm.
The study aims to determine whether hyaluronic acid and polynucleotides (Regenfast®) combined with bovine bone graft material (Bio-Oss®) provides similar or improved periodontal regeneration compared with enamel matrix derivative proteins (Emdogain®) combined with Bio-Oss®.
Researchers will evaluate:
* Periodontal healing and bone regeneration
* Changes in probing depth, clinical attachment level, gingival recession, and tooth mobility
* Radiographic bone fill
* Survival of treated teeth after 1, 3, and 5 years
Participants will:
* Receive initial periodontal treatment and oral hygiene instruction
* Undergo clinical and radiographic evaluation
* Receive minimally invasive periodontal regenerative surgery under local anesthesia
* Be randomly assigned to receive either Regenfast® + Bio-Oss® or Emdogain® + Bio-Oss®
* Attend follow-up visits with periodontal examinations and radiographs over 5 years
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 aged 18 years or older
* Non-smokers or light smokers (fewer than 10 cigarettes per day)
* No diabetes or well-controlled diabetes
* At least one infrabony periodontal defect ≥ 3 mm in depth
* Periodontal pocket depth ≥ 6 mm at baseline (after initial treatment)
* Full-mouth plaque and bleeding scores ≤ 20%, ≤15% at re-evaluation
* Ability and willingness to attend follow-up visits for 1, 3, and 5 years
* Teeth included in the study must be healthy from an endodontic point of view or properly root-treated
Exclusion Criteria:
* Pregnant or breastfeeding women
* Patients with weakened immune systems or significant systemic diseases
* Heavy smokers (more than 10 cigarettes per day)
* Full-mouth plaque or bleeding scores \>20%, \>15%
* Current alcohol or drug abuse
* Patients who have received periodontal treatment within the last 6 months
* Patients unwilling or unable to attend follow-up visits required for the study
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
1
Clinical Attachment Level
Timeframe: Baseline, 12 months, 3 years, and 5 years after surgery