An interventional study of Hyaluronic acid and Enamel matrix derivatives in Periodontitis, sponsored by University of Turin, Italy. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by University of Turin, Italy · Not applicable, Interventional, and Treatment
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.
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Exclusion criteria:
Minimally invasive surgical technique with a combined approach using hyaluronic acid gel and a bone xenograft.
Device: Hyaluronic acid
Minimally invasive surgical technique with a combined approach using enamel matrix derivatives gel and a bone xenograft.
Device: Enamel matrix derivatives
Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Application of cross-linked hyaluronic acid gel composed of a mixture of cross-linked (1.6%) and natural (0.2%) hyaluronic acid (hyaDent BG, Regedent, Germany) through a syringe over a bone xenograft (Smartgraft, Regedent, Germany). The mixture will be then compacted within the intrabony component of the defect.
Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Enamel matrix derivatives gel (Emdogain, Straumann, Switzerland) will be applied on the dry root surfaces and left in place for at least 1 minute avoiding blood contamination. Subsequently, a bone xenograft (Smartgraft, Regedent, Germany) will be compacted within the intrabony component of the defect.
Clinical attachment level change
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time frame: 24 months
Probing pocket depth change
Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time frame: 24 months
Radiographic bone level change
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)
Time frame: 24 months
Patient reported outcome measures
Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)
Time frame: 14 weeks
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University of Turin, Italy