Studio Cortellini
Florence, 50132, Italy
NCT Number: NCT05225142
Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Florence, 50132, Italy
This 10-year follow-up of a randomized controlled clinical trial (Cortellini & Tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (M-MIST, N=15); ii) a second group was treated with M-MIST combined with enamel matrix derivative (M-MIST EMD, N=15, Straumann, Switzerland); iii) a third group was treated with M-MIST+EMD plus Bone Mineral Derived Xenograph (M-MIST+EMD+BMDX, N=15, Geistlich, Switzerland) . The design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (Cortellini & Tonetti 2011). Clinical outcomes of the three groups were longitudinally followed for 10 years. The 10-year follow-up was approved by the local ethical committee for clinical research of the Health Service of Tuscany (University Hospital of Firenze protocol ATRO2019, registration n° 15106_oss). All patients gave informed consent to participate into the clinical trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical intervention alone
Other names: M-MIST
Surgical intervention with local application of regenerative biomaterial
Other names: M-MIST with EMD
Surgical intervention with local application of regenerative biomaterial and bone replacement graft
Other names: M-MIST EMD+BRG
Time frame: 10 years
Periodontal probing to the nearest millimetre
Time frame: 10 years
Periodontal maintainability
Time frame: 10 years
Survival of treated teeth - Kaplan Mayer
Time frame: 10 years
Survival until first episode of recurrence requiring re-treatment
Time frame: 10 years
Total cost of managing the regretted teeth including treatment of recurrence
Time frame: 10 years
Changes in level of bone supporting the tooth
The European Research Group on Periodontology (ERGOPerio)
Network
Modified Minimally Invasive Surgical Technique in Human Intrabony Defects With or Without Regenerative Materials 10-year Follow-up of a Randomized Clinical Trial: Tooth Retention, Periodontitis Recurrence and Costs
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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