Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives
ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Turin, Italy
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Compromised general health which contraindicates the study procedures (ASA III-VI patients).
Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug/alcohol abusers.
Pregnant or nursing women.
Trial design
Design model
Parallel
Treatments tested in this trial
Hyaluronic acid
DeviceMinimally 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.
Enamel matrix derivatives
DeviceMinimally 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Hyaluronic acidExperimental treatment 1 intervention
Group B: Enamel matrix derivativesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
Patient reported outcome measures
Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)
Time frame
14 weeksSponsors and contacts
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Source ClinicalTrials.gov