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OpenTrials
Completed

NCT Number: NCT05225142

10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Studio Cortellini

Florence, 50132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified minimally invasive surgery

Procedure

Surgical intervention alone

Other names: M-MIST

Modified minimally invasive surgery with enamel matrix derivative

Procedure

Surgical intervention with local application of regenerative biomaterial

Other names: M-MIST with EMD

Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft

Procedure

Surgical intervention with local application of regenerative biomaterial and bone replacement graft

Other names: M-MIST EMD+BRG

Primary outcomes

  1. Clinical attachment level changes

    Time frame: 10 years

    Periodontal probing to the nearest millimetre

Secondary outcomes

  1. Probing pocket depts

    Time frame: 10 years

    Periodontal maintainability

  2. Tooth survival

    Time frame: 10 years

    Survival of treated teeth - Kaplan Mayer

  3. Complication-free survival

    Time frame: 10 years

    Survival until first episode of recurrence requiring re-treatment

  4. Cost of recurrence

    Time frame: 10 years

    Total cost of managing the regretted teeth including treatment of recurrence

  5. Radiographic bone level

    Time frame: 10 years

    Changes in level of bone supporting the tooth

Sponsors and collaborators

Lead sponsor

The European Research Group on Periodontology (ERGOPerio)

Network

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2020
First posted
Feb 4, 2022
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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