Intrabony Periodontal Defect Clinical Trial
Official title:
The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial
Verified date | December 2023 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 15, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | CIR Dental School | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 12 months | |
Secondary | 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) | 12 months | |
Secondary | 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) | 12 months |
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