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10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

Sponsor
The European Research Group on Periodontology (ERGOPerio) (Other)
Overall Status
Completed
CT.gov ID
NCT05225142
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
158.9
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Long term follow up of RCTLong term follow up of RCT
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
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Dec 31, 2009
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical attachment level changes [10 years]

      Periodontal probing to the nearest millimetre

    Secondary Outcome Measures

    1. Probing pocket depts [10 years]

      Periodontal maintainability

    2. Tooth survival [10 years]

      Survival of treated teeth - Kaplan Mayer

    3. Complication-free survival [10 years]

      Survival until first episode of recurrence requiring re-treatment

    4. Cost of recurrence [10 years]

      Total cost of managing the regretted teeth including treatment of recurrence

    5. Radiographic bone level [10 years]

      Changes in level of bone supporting the tooth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Studio Cortellini Florence Italy 50132

    Sponsors and Collaborators

    • The European Research Group on Periodontology (ERGOPerio)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The European Research Group on Periodontology (ERGOPerio)
    ClinicalTrials.gov Identifier:
    NCT05225142
    Other Study ID Numbers:
    • ATRO M-MIST
    First Posted:
    Feb 4, 2022
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontitis

    Study Results

    No Results Posted as of Feb 4, 2022