Using hyaluronic acid or enamel matrix derivatives for periodontal regeneration
Minimally Invasive Periodontal Regeneration With a Combination Approach Using Either Hyaluronic Acid or Enamel Matrix Derivatives: a 24-month Multicenter Randomized Controlled Clinical Trial
This study tests whether using hyaluronic acid or enamel matrix derivatives with a bone graft can help people with gum disease heal better and improve their gum health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Turin, Italy Academic / other |
| Locations | 1 site (Turin) |
| Trial ID | NCT06105112 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a bone graft combined with either hyaluronic acid or enamel matrix derivatives for regenerating periodontal tissue in patients with non-containing intrabony defects due to periodontitis. The primary focus is on measuring clinical attachment gain, while secondary outcomes include probing pocket depth reduction and radiographic bone fill. Additionally, the study aims to assess early wound healing and gather patient-reported outcomes to understand the overall impact of the treatments.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with stage III-IV periodontitis who have completed initial periodontal therapy and have specific intrabony defects.
Not a fit: Patients with compromised general health or systemic diseases that could affect treatment outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve periodontal regeneration techniques, leading to better clinical outcomes for patients with periodontitis.
How similar studies have performed: Previous studies have shown promising results with similar regenerative approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Diagnosis of stage III-IV periodontitis. * Completed steps I-II periodontal therapy. * FMPS \<15% at 3-month re-evaluation. * FMBS \<15% at 3-month re-evaluation. * At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, and limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding. * Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion) and it needs to be accessible by flap elevation only on one side (either buccal or oral). * Signed informed consent. Exclusion criteria: * Compromised general health which contraindicates the study procedures (ASA III-VI patients). * Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives). * Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug/alcohol abusers. * Pregnant or nursing women. * Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
Where this trial is running
Turin
- CIR Dental School — Turin, Italy (Recruiting)
Study contacts
- Study coordinator: Mario Aimetti, PA
- Email: mario.aimetti@unito.it
- Phone: 011 6331546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.