NCT05225142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2009

Completed
10.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

January 25, 2022

Last Update Submit

February 3, 2022

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Clinical attachment level changes

    Periodontal probing to the nearest millimetre

    10 years

Secondary Outcomes (5)

  • Probing pocket depts

    10 years

  • Tooth survival

    10 years

  • Complication-free survival

    10 years

  • Cost of recurrence

    10 years

  • Radiographic bone level

    10 years

Study Arms (3)

Modified minimally invasive surgery alone

EXPERIMENTAL

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

Modified minimally invasive surgery with enamel matrix derivative

ACTIVE COMPARATOR

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

Procedure: Modified minimally invasive surgeryProcedure: Modified minimally invasive surgery with enamel matrix derivative

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

ACTIVE COMPARATOR

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

Interventions

Modified minimally invasive surgeryPROCEDURE

Surgical intervention alone

Also known as: M-MIST
Modified minimally invasive surgery aloneModified minimally invasive surgery with enamel matrix derivativeModified minimally invasive surgery with enamel matrix derivative and bone replacement graft
Modified minimally invasive surgery with enamel matrix derivativePROCEDURE

Surgical intervention with local application of regenerative biomaterial

Also known as: M-MIST with EMD
Modified minimally invasive surgery with enamel matrix derivativeModified minimally invasive surgery with enamel matrix derivative and bone replacement graft
Modified minimally invasive surgery with enamel matrix derivative and bone replacement graftPROCEDURE

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

Also known as: M-MIST EMD+BRG
Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with periodontitis
  • Presence of one intrabony defect not extending into furcation
  • Good general health
  • Adequate plaque control

You may not qualify if:

  • Furcation involvement in the experimental tooth
  • Inadequate control of periodontitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Studio Cortellini

Florence, 50132, Italy

Location

MeSH Terms

Conditions

Periodontitis

Interventions

emerin

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Pierpaolo Cortellini, MD

    ATRO - ERGOPERIO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation concealment of surgeon until completion of common part of surgical intervention. Examiner (clinical and radiographic ) and other carers blind to allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Long term follow up of RCT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

January 1, 2007

Primary Completion

December 31, 2009

Study Completion

March 31, 2020

Last Updated

February 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

No plan to share data

Locations

IT(1)