Status:
UNKNOWN
Flapless Approach for the Treatment of Intrabony Defects
Lead Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions:
Intrabony Periodontal Defect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The use of Enamel Matrix Derivative (EMD) associated to microsurgical flaps was demonstrated to be effective for the treatment of intrabony defects, in particular in presence of a self-contained anato...
Detailed Description
The secondary aims of the study are: * to evaluate the comparative effectiveness of the proposed treatment evaluating patient-centered outcomes. * to evaluate, after one year from the treatment, the ...
Eligibility Criteria
Inclusion
- Men and women over or equal to the age of 18 years
- Patients who are able to understand the requirements of the study and are willing and able to comply with its instructions and schedules
- Patients who had provided written informed consent to participate in the study prior to any study procedure
- Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (American Society of Anesthesiologists ASA 1 or ASA-2)
- Patients having one or more self-contained (3-wall or 2-3 walls) intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation.
Exclusion
- FMPS% \> 15%
- FMBS% \> 15%
- Treatment with anticoagulant drugs (International Normalized Ratio (INR) above 2,5)
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants drugs
- untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements
- Patients with history of alcohol, narcotics or drug abuse
- Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years
- Patients through at any time received radiotherapy to the head and neck region will be excluded anyway
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
- Degenerative diseases
- Osteoradionecrosis
- Renal failure
- Organ transplant recipients
- HIV positive (self-declaration)
- Malignant diseases
- Diseases that compromise the immune system
- Unbalanced diabetes (HbA1c above 7.2 assessed by self-declaration)
- Psychotic diseases
- Hypersensitivity or specific contraindications to one of the components of EMD
- Women who are pregnant (self-declaration); or lactating at the time of recruitment and of surgery
- Site where a history of failed periodontal regenerative procedure in the last two years
- Heavy Smokers (10 cigarettes and more per day).
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05354037
Start Date
May 13 2021
End Date
April 30 2023
Last Update
April 29 2022
Active Locations (1)
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1
Istituto Ortopedico Galeazzi
Milan, Italy, 20161