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Clinical Trials/NCT05456555
NCT05456555
Completed
Not Applicable

The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial

University of Turin, Italy1 site in 1 country46 target enrollmentSeptember 1, 2022
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ConditionsPeriodontitis, AdultIntrabony Periodontal Defect

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis, Adult
Sponsor
University of Turin, Italy
Enrollment
46
Locations
1
Primary Endpoint
Clinical attachment level change
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
December 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Turin, Italy
Responsible Party
Principal Investigator
Principal Investigator

Mario Aimetti

Professor

University of Turin, Italy

Eligibility Criteria

Inclusion Criteria

  • •diagnosis of periodontitis stage III or IV;
  • •presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy;
  • •a full-mouth plaque score and full-mouth bleeding score \<15% at the time of the experimental procedure;
  • •signed informed consent.

Exclusion Criteria

  • •relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing;
  • •consumption of drugs known to affect periodontal status;
  • •pregnancy and lactation;
  • •third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration;
  • •heavy smokers \>10 cigarettes per day.

Outcomes

Primary Outcomes

Clinical attachment level change

Time Frame: 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 Outcomes

  • Radiographic bone level change(12 months)
  • Probing pocket depth change(12 months)

Study Sites (1)

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