10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Procedure: Modified minimally invasive surgery
* Procedure: Modified minimally invasive surgery with enamel matrix derivative
* Procedure: Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with periodontitis Presence of one intrabony defect not extending into furcation Good general health Adequate plaque control Exclusion Criteria: Furcation involvement in the experimental tooth Inadequate control of periodontitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Long term follow up of RCT
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified minimally invasive surgery alone<br>Modified minimally invasive surgery alone for access and debridement of intrabony defect. This approach maximises wound stability. No application of regenerative biomaterial. | Procedure: Modified minimally invasive surgery<br>* Surgical intervention alone<br>* Other names: M-MIST;|
| Active Comparator: Modified minimally invasive surgery with enamel matrix derivative<br>Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative (regenerative biomaterial) | Procedure: Modified minimally invasive surgery<br>* Surgical intervention alone<br>* Other names: M-MIST;Procedure: Modified minimally invasive surgery with enamel matrix derivative<br>* Surgical intervention with local application of regenerative biomaterial<br>* Other names: M-MIST with EMD;|
| Active Comparator: Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft<br>Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative and bone replacement graft (regenerative biomaterial) | Procedure: Modified minimally invasive surgery<br>* Surgical intervention alone<br>* Other names: M-MIST;Procedure: Modified minimally invasive surgery with enamel matrix derivative<br>* Surgical intervention with local application of regenerative biomaterial<br>* Other names: M-MIST with EMD;Procedure: Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft<br>* Surgical intervention with local application of regenerative biomaterial and bone replacement graft<br>* Other names: M-MIST EMD+BRG;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level changes | Periodontal probing to the nearest millimetre | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depts | Periodontal maintainability | 10 years | 
| Tooth survival | Survival of treated teeth - Kaplan Mayer | 10 years | 
| Complication-free survival | Survival until first episode of recurrence requiring re-treatment | 10 years | 
| Cost of recurrence | Total cost of managing the regretted teeth including treatment of recurrence | 10 years | 
| Radiographic bone level | Changes in level of bone supporting the tooth | 10 years |