Intrabony Periodontal Defect Clinical Trial
Official title:
Flapless Approach for the Treatment of Self-contained Intrabony Defects: a Randomized Controlled Clinical Trial
NCT number | NCT05354037 |
Other study ID # | FLPERIO |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 13, 2021 |
Est. completion date | April 30, 2023 |
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 anatomy. The main aim of this study will be to evaluate the difference in Clinical Attachment Level (CAL) between baseline and 1-year follow-up, comparing flapless periodontal regeneration using EMD versus the use of EMD after microsurgical flap elevation (Modified-Minimally Invasive Surgical Technique (M-MIST) / Single-flap approach).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 30, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Galeazzi | Milan |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Galeazzi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in CAL between baseline and 1-year follow-up | The difference between CAL values at baseline and after 1 year; CAL is defined as the distance between CEJ and the most apical extent of the pocket / sulcus | 1 year | |
Secondary | Difference in PD between baseline and 1-year follow-up | The difference between PD values at baseline and after 1 year; PD is defined as the distance between the gingival margin and the most apical extent of the pocket / sulcus | 1 year | |
Secondary | Difference in REC between baseline and 1-year follow-up | The difference between REC values at baseline and after 1 year; REC is defined as the distance between the CEJ and the gingival margin | 1 year | |
Secondary | Difference in PI between baseline and 1-year follow-up | The difference between PI values at baseline and after 1 year; PI value is 1 if we can detect the presence of plaque or 0 if not | 1 year | |
Secondary | Difference in BI between baseline and 1-year follow-up | The difference between BI values at baseline and after 1 year; BI value is 1 if we can detect the presence of bleeding or 0 if not | 1 year | |
Secondary | Difference in FMBS% between baseline and 1-year follow-up | The difference between FMBS% values at baseline and after 1 year; FMBS% is calculated as the percentage of sites in the whole mouth presenting bleeding | 1 year | |
Secondary | Difference in FMPS% between baseline and 1-year follow-up | The difference between FMPS% values at baseline and after 1 year; FMPS% is calculated as the percentage of sites in the whole mouth presenting plaque | 1 year | |
Secondary | Proportion of treated sites for each group that presented PD <= 3 mm | The number of sites in the whole mouth with PD equal or less than 3 mm | 1 year | |
Secondary | Tooth retention | The presence of tooth in position without any sign / symptom of acute inflammation (abscess, periodical periodontitis) | 1 year |
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