Treatment of Intraosseous Periodontal Defects With Amelogenins
NCT ID: NCT05315804
Last Updated: 2024-02-28
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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RECRUITING
NA
22 participants
INTERVENTIONAL
2023-02-01
2024-10-01
Brief Summary
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A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).
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Detailed Description
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Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).
Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).
After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
In the B group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Amelogenin Group (A)
Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)
MINSD and amelogenins
After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
No-amelogenin Group (B)
Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed
MINSD
Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Interventions
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MINSD and amelogenins
After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
MINSD
Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old;
* Presence of at least 10 teeth per arch;
* Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
* Presence of at least one intraosseous pocket;
* Single-rooted and multi-rooted teeth.
Exclusion Criteria
* Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
* Pregnant or lactating;
* Tobacco smokers (≥ 10 cigarettes per day);
* Multi-rooted teeth with furcation involvement;
* Third molars.
18 Years
70 Years
ALL
Yes
Sponsors
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Federico II University
OTHER
Responsible Party
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Luca Ramaglia
Clinical Professor
Principal Investigators
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Luca Ramaglia
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
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University of Naples Federico II
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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477/21
Identifier Type: -
Identifier Source: org_study_id
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