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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05456555
Other study ID # EMDTurin1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 15, 2023

Study information

Verified date December 2023
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Procedure:
Flapless with Enamel Matrix Derivatives (EMD)
Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. In the test group, the roots will be conditioned with 24% ethylenediaminetetraacetic acid (EDTA) for 2 minutes. After rinsing with sterile saline, enamel matrix derivatives (EMD) will be applied on the dried root surface.
Flapless without Enamel Matrix Derivatives (EMD)
Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. No adjunct will be administered.

Locations

Country Name City State
Italy CIR Dental School Turin

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

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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