Using palatal tissue grafts to improve periodontal healing

Periodontal Regeneration in Non-contained Intrabony Defects Using Autologous Micrografts From the Palatal Mucosa: a Randomized Controlled Clinical Trial

This study tests if using tissue grafts from the roof of the mouth along with a special support material can help people with advanced gum disease heal better than just using the support material alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Turin, Italy (other)
• Locations: 1 site (Turin)
• Trial ID: NCT06105125 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of using autologous micrografts from the palatal mucosa combined with an alloplastic scaffold for regenerating periodontal tissue in patients with stage III-IV periodontitis. The primary focus is on measuring clinical attachment level gain, while secondary outcomes include probing pocket depth reduction and radiographic bone fill. Additionally, the study will compare early wound healing and patient-reported outcomes between the two treatment groups: one receiving the micrograft and scaffold, and the other receiving only the scaffold.

Who should consider this trial

Good fit: Ideal candidates are patients with stage III-IV periodontitis who have completed non-surgical periodontal therapy and have specific intrabony defects.

Not a fit: Patients with compromised general health or systemic diseases that could affect treatment outcomes will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance periodontal regeneration and improve patient outcomes in those suffering from advanced periodontitis.

How similar studies have performed: Previous studies have shown promising results with similar approaches using autologous grafts for tissue regeneration, indicating potential for success in this trial.

Eligibility criteria

Patients selected for the study should fulfil the following inclusion criteria:

* Affected from stage III-IV periodontitis.
* Completed non-surgical periodontal therapy.
* FMPS \<15% at 3-month re-evaluation.
* FMBS \<15% at 3-month re-evaluation.
* At least one site with an interproximal intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, extending to the lingual/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), requiring flap elevation on both buccal and oral side for its accessibility.
* 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), immunoregulatory drugs (e.g., cyclosporine), and high-dose oral contraceptives.
* Current smokers (self-reported), users of chewing tobacco, and drug/alcohol abusers.
* Pregnant or nursing women.
* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
* Very large and wide defects that required the use of membrane.

Where this trial is running

Turin

• CIR Dental School — Turin, Italy (RECRUITING)

Study contacts

• Study coordinator: Mario Aimetti, PA

Conditions: Periodontitis