Minimally Invasive Periodontal Regeneration With a Combination Approach Using Either Hyaluronic Acid or Enamel Matrix Derivatives: a 24-month Multicenter Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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 preoperative bone sounding.

• 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.

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: 2023-10-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 60
Treatments
Experimental: Hyaluronic acid
Minimally invasive surgical technique with a combined approach using hyaluronic acid gel and a bone xenograft.
Active_comparator: Enamel matrix derivatives
Minimally invasive surgical technique with a combined approach using enamel matrix derivatives gel and a bone xenograft.
Related Therapeutic Areas
Sponsors
Leads: University of Turin, Italy

This content was sourced from clinicaltrials.gov