NCT05225142

10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: The European Research Group on Periodontology (ERGOPerio) · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Modified minimally invasive surgery	Surgical intervention alone
PROCEDURE	Modified minimally invasive surgery with enamel matrix derivative	Surgical intervention with local application of regenerative biomaterial
PROCEDURE	Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft	Surgical intervention with local application of regenerative biomaterial and bone replacement graft

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-12-31
• Completion: 2020-03-31
• First posted: 2022-02-04
• Last updated: 2022-02-04

Locations

1 site across 1 country: Italy