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10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

Primary Purpose

Periodontitis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Modified minimally invasive surgery

Modified minimally invasive surgery with enamel matrix derivative

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

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Studio Cortellini

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Modified minimally invasive surgery alone

Modified minimally invasive surgery with enamel matrix derivative

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

Arm Description

Modified minimally invasive surgery alone for access and debridement of intrabony defect. This approach maximises wound stability. No application of regenerative biomaterial.

Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative (regenerative biomaterial)

Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative and bone replacement graft (regenerative biomaterial)

Outcomes

Primary Outcome Measures

Clinical attachment level changes

Periodontal probing to the nearest millimetre

Secondary Outcome Measures

Probing pocket depts

Periodontal maintainability

Tooth survival

Survival of treated teeth - Kaplan Mayer

Complication-free survival

Survival until first episode of recurrence requiring re-treatment

Cost of recurrence

Total cost of managing the regretted teeth including treatment of recurrence

Radiographic bone level

Changes in level of bone supporting the tooth

Full Information

NCT ID

NCT05225142

First Posted

January 25, 2022

Last Updated

February 3, 2022

Sponsor

The European Research Group on Periodontology (ERGOPerio)

1. Study Identification

Unique Protocol Identification Number

NCT05225142

Brief Title

10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2007 (Actual)

Primary Completion Date

December 31, 2009 (Actual)

Study Completion Date

March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The European Research Group on Periodontology (ERGOPerio)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Long term follow up of RCT

Masking

InvestigatorOutcomes 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

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modified minimally invasive surgery alone

Arm Type

Experimental

Arm Description

Modified minimally invasive surgery alone for access and debridement of intrabony defect. This approach maximises wound stability. No application of regenerative biomaterial.

Arm Title

Modified minimally invasive surgery with enamel matrix derivative

Arm Type

Active Comparator

Arm Description

Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative (regenerative biomaterial)

Arm Title

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

Arm Type

Active Comparator

Arm Description

Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative and bone replacement graft (regenerative biomaterial)

Intervention Type

Procedure

Intervention Name(s)

Modified minimally invasive surgery

Other Intervention Name(s)

M-MIST

Intervention Description

Surgical intervention alone

Intervention Type

Procedure

Intervention Name(s)

Modified minimally invasive surgery with enamel matrix derivative

Other Intervention Name(s)

M-MIST with EMD

Intervention Description

Surgical intervention with local application of regenerative biomaterial

Intervention Type

Procedure

Intervention Name(s)

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

Other Intervention Name(s)

M-MIST EMD+BRG

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical attachment level changes

Description

Periodontal probing to the nearest millimetre

Time Frame

10 years

Secondary Outcome Measure Information:

Title

Probing pocket depts

Description

Periodontal maintainability

Time Frame

10 years

Title

Tooth survival

Description

Survival of treated teeth - Kaplan Mayer

Time Frame

10 years

Title

Complication-free survival

Description

Survival until first episode of recurrence requiring re-treatment

Time Frame

10 years

Title

Cost of recurrence

Description

Total cost of managing the regretted teeth including treatment of recurrence

Time Frame

10 years

Title

Radiographic bone level

Description

Changes in level of bone supporting the tooth

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierpaolo Cortellini, MD

Organizational Affiliation

ATRO - ERGOPERIO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Studio Cortellini

City

Florence

ZIP/Postal Code

50132

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share data

Learn more about this trial

10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

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