Actively Recruiting
Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives
Led by University of Turin, Italy · Updated on 2023-10-27
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.
CONDITIONS
Official Title
Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of stage III-IV periodontitis
- Completed steps I-II periodontal therapy
- Full mouth plaque score (FMPS) less than 15% at 3-month re-evaluation
- Full mouth bleeding score (FMBS) less than 15% at 3-month re-evaluation
- At least one site with intrabony defects and residual probing pocket depth (PPD) of 6 mm or more at re-evaluation
- Radiographic intrabony component of 3 mm or more
- Limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding
- Defect has non-supporting anatomy with 1-2 residual walls in its coronal portion and is accessible by flap elevation on only one side (buccal or oral)
- Signed informed consent
You will not qualify if you...
- Compromised general health that contraindicates study procedures (ASA III-VI patients)
- Systemic diseases or medications that could affect therapy outcomes, such as uncontrolled diabetes, non-plaque-induced gingival diseases, use of phenytoin, sodium valproate, certain calcium channel blockers (nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (ciclosporine), or high-dose oral contraceptives
- Current smokers who smoke 10 or more cigarettes a day, users of chewing tobacco, or drug/alcohol abusers
- Pregnant or nursing women
- Presence of furcation involvement of degree II or higher at affected teeth
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CIR Dental School
Turin, Italy, 10126
Actively Recruiting
Research Team
M
Mario Aimetti, PA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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