Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration

Not Applicable

Recruiting

• Conditions: Periodontitis
• Interventions: Device: Bone substitute alone; Device: Rigenera + bone substitute

• Registration Number: NCT06105125
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Status Verified: 2023-11
• Study Start: 2023-11-02
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-11-02
• Study Completion: 2025-11-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Bone substitute alone	Modified papilla preservation technique with a combined approach using a bone substitute.
Autologous micrograft from the palate	Rigenera + bone substitute	Modified papilla preservation technique with a combined approach using a bone substitute soaked with autologous micrografts from the palate.

Primary Outcome Measures

Name	Time	Method
Clinical attachment level change	12 months	Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Secondary Outcome Measures

Name	Time	Method
Radiographic bone level change	12 months	Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)
Probing pocket depth change	12 months	Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Patient reported outcome measures	2 weeks	Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)

Trial Locations

Locations (1)

CIR Dental School; 🇮🇹 Turin, Italy