Clinical trial NCT06105125: Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration
Official title: Periodontal Regeneration in Non-contained Intrabony Defects Using Autologous Micrografts From the Palatal Mucosa: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some research studies have demonstrated that autologous micrografts made out of different oral tissues may enhance tissue regeneration. The primary aim of this study is to evaluate the clinical performance of a combined approach using an autologous micrograft derived from the palatal mucosa with an alloplastic scaffold for periodontal regeneration of intrabony defects in terms of clinical attachment level gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill) compared to a scaffold alone. Moreover, this study aims to compare early wound healing and patient-reported outcome measures between the two groups.


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.

Primary outcomes:
measure: Clinical attachment level change
timeFrame: 12 months
Secondary outcomes:
measure: Probing pocket depth change
timeFrame: 12 months
measure: Radiographic bone level change
timeFrame: 12 months
measure: Patient reported outcome measures
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Turin
country: Italy
facility: CIR Dental School
Study officials:
References: