Periodontitis
Conditions
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.
Interventions
PROCEDUREModified minimally invasive surgery
Surgical intervention alone
PROCEDUREModified minimally invasive surgery with enamel matrix derivative
Surgical intervention with local application of regenerative biomaterial
PROCEDUREModified minimally invasive surgery with enamel matrix derivative and bone replacement graft
Surgical intervention with local application of regenerative biomaterial and bone replacement graft
Sponsors
The European Research Group on Periodontology (ERGOPerio)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Allocation concealment of surgeon until completion of common part of surgical intervention. Examiner (clinical and radiographic ) and other carers blind to allocation
Intervention model description
Long term follow up of RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level changes | 10 years | Periodontal probing to the nearest millimetre |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depts | 10 years | Periodontal maintainability |
| Tooth survival | 10 years | Survival of treated teeth - Kaplan Mayer |
| Complication-free survival | 10 years | Survival until first episode of recurrence requiring re-treatment |
| Cost of recurrence | 10 years | Total cost of managing the regretted teeth including treatment of recurrence |
| Radiographic bone level | 10 years | Changes in level of bone supporting the tooth |
Countries
Italy
Outcome results
None listed