Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2022-09-01
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Flapless with Enamel Matrix Derivatives (EMD)
Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD).
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 alone
Closed non-surgical treatment of periodontal intrabony defects without any adjunct.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Mario Aimetti
Professor
Locations
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CIR Dental School
Turin, , Italy
Countries
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References
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Aimetti M, Stasikelyte M, Mariani GM, Cricenti L, Baima G, Romano F. The flapless approach with and without enamel matrix derivatives for the treatment of intrabony defects: A randomized controlled clinical trial. J Clin Periodontol. 2024 Sep;51(9):1112-1121. doi: 10.1111/jcpe.14028. Epub 2024 Jun 10.
Other Identifiers
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EMDTurin1
Identifier Type: -
Identifier Source: org_study_id