Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives

Not Applicable

Recruiting

• Conditions: Periodontitis
• Interventions: Device: Hyaluronic acid; Device: Enamel matrix derivatives

• Registration Number: NCT06105112
• Lead Sponsor: University of Turin, Italy

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid	Hyaluronic acid	Minimally invasive surgical technique with a combined approach using hyaluronic acid gel and a bone xenograft.
Enamel matrix derivatives	Enamel matrix derivatives	Minimally invasive surgical technique with a combined approach using enamel matrix derivatives gel and a bone xenograft.

Primary Outcome Measures

Name	Time	Method
Clinical attachment level change	24 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
Patient reported outcome measures	14 weeks	Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)
Probing pocket depth change	24 months	Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Radiographic bone level change	24 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)

Trial Locations

Locations (1)

CIR Dental School; 🇮🇹 Turin, Italy