10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

February 3, 2022 updated by: The European Research Group on Periodontology (ERGOPerio)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50132
        • Studio Cortellini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified minimally invasive surgery alone
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
Surgical intervention alone
Other Names:
  • M-MIST
Active Comparator: Modified minimally invasive surgery with enamel matrix derivative
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
Surgical intervention alone
Other Names:
  • M-MIST
Procedure: Modified minimally invasive surgery with enamel matrix derivative
Surgical intervention with local application of regenerative biomaterial
Other Names:
  • M-MIST with EMD
Active Comparator: Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft
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
Surgical intervention alone
Other Names:
  • M-MIST
Procedure: Modified minimally invasive surgery with enamel matrix derivative
Surgical intervention with local application of regenerative biomaterial
Other Names:
  • M-MIST with EMD
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
Other Names:
  • M-MIST EMD+BRG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The European Research Group on Periodontology (ERGOPerio)

Investigators

  • Principal Investigator: Pierpaolo Cortellini, MD, ATRO - ERGOPERIO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

December 31, 2009

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATRO M-MIST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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