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New treatment option for Periodontitis
Official title Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives
ClinicalTrials.gov ID: NCT06105112
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Turin, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turin, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.