10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

Periodontitis 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225142
• Other study ID #: ATRO M-MIST
• Status: Completed
• Phase: N/A
• Start date: January 1, 2007
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2022
• Source: The European Research Group on Periodontology (ERGOPerio)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Modified minimally invasive surgery
Surgical intervention alone
• Modified minimally invasive surgery with enamel matrix derivative
Surgical intervention with local application of regenerative biomaterial
• Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft
Surgical intervention with local application of regenerative biomaterial and bone replacement graft

Locations

Country	Name	City	State
Italy	Studio Cortellini	Florence

Sponsors (1)

Lead Sponsor	Collaborator
The European Research Group on Periodontology (ERGOPerio)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level changes	Periodontal probing to the nearest millimetre	10 years
Secondary	Probing pocket depts	Periodontal maintainability	10 years
Secondary	Tooth survival	Survival of treated teeth - Kaplan Mayer	10 years
Secondary	Complication-free survival	Survival until first episode of recurrence requiring re-treatment	10 years
Secondary	Cost of recurrence	Total cost of managing the regretted teeth including treatment of recurrence	10 years
Secondary	Radiographic bone level	Changes in level of bone supporting the tooth	10 years