Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients
NCT ID: NCT04237662
Last Updated: 2020-11-04
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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UNKNOWN
NA
38 participants
INTERVENTIONAL
2021-01-01
2023-12-31
Brief Summary
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Detailed Description
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Metabolic glucose control as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control Group
Root Instrumentation
Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one- stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.
Root Instrumentation
Instrumentation of the root surface in order to achieve debridement
Test Group
Root Instrumentation + Enamel Matrix Derivative Application
Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one- stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.
In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.
Root Instrumentation
Instrumentation of the root surface in order to achieve debridement
Enamel Matrix Derivative application
Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths
Interventions
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Root Instrumentation
Instrumentation of the root surface in order to achieve debridement
Enamel Matrix Derivative application
Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths
Eligibility Criteria
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Inclusion Criteria
* No previous periodontal treatment in the last 6 months;
* Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non- adjacent teeth);
* Ability to understand the study procedures and comply with them through the length of the study.
Exclusion Criteria
* Need for antibiotic treatment during periodontal therapy;
* Chronic infections;
* Systemic diseases;
* Patients who report current smoking over 20 cigarettes per day.
18 Years
75 Years
ALL
No
Sponsors
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University of Pisa
OTHER
Responsible Party
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Filippo Graziani, DDS MClinDent PhD
Full Professor
Locations
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University Hospital of Pisa
Pisa, , Italy
Countries
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Facility Contacts
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References
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Graziani F, Gennai S, Petrini M, Bettini L, Tonetti M. Enamel matrix derivative stabilizes blood clot and improves clinical healing in deep pockets after flapless periodontal therapy: A Randomized Clinical Trial. J Clin Periodontol. 2019 Feb;46(2):231-240. doi: 10.1111/jcpe.13074.
Other Identifiers
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3649-2019
Identifier Type: -
Identifier Source: org_study_id