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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
CIR Dental School
RECRUITING
Turin
Contact Information
Primary
Mario Aimetti, PA
mario.aimetti@unito.it
011 6331546
Time Frame
Start Date: 2023-11-02
Estimated Completion Date: 2025-11-02
Participants
Target number of participants: 38
Treatments
Experimental: Autologous micrograft from the palate
Modified papilla preservation technique with a combined approach using a bone substitute soaked with autologous micrografts from the palate.
Active_comparator: Control group
Modified papilla preservation technique with a combined approach using a bone substitute.
Related Therapeutic Areas
Sponsors
Leads: University of Turin, Italy

This content was sourced from clinicaltrials.gov