10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

NCT ID: NCT05225142

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-01

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Long term follow up of RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Allocation concealment of surgeon until completion of common part of surgical intervention. Examiner (clinical and radiographic ) and other carers blind to allocation

Study Groups

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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.

Group Type EXPERIMENTAL

Modified minimally invasive surgery

Intervention Type PROCEDURE

Surgical intervention alone

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)

Group Type ACTIVE_COMPARATOR

Modified minimally invasive surgery

Intervention Type PROCEDURE

Surgical intervention alone

Modified minimally invasive surgery with enamel matrix derivative

Intervention Type PROCEDURE

Surgical intervention with local application of regenerative biomaterial

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)

Group Type ACTIVE_COMPARATOR

Modified minimally invasive surgery

Intervention Type PROCEDURE

Surgical intervention alone

Modified minimally invasive surgery with enamel matrix derivative

Intervention Type PROCEDURE

Surgical intervention with local application of regenerative biomaterial

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

Intervention Type PROCEDURE

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

Interventions

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Modified minimally invasive surgery

Surgical intervention alone

Intervention Type PROCEDURE

Modified minimally invasive surgery with enamel matrix derivative

Surgical intervention with local application of regenerative biomaterial

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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M-MIST M-MIST with EMD M-MIST EMD+BRG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The European Research Group on Periodontology (ERGOPerio)

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierpaolo Cortellini, MD

Role: PRINCIPAL_INVESTIGATOR

ATRO - ERGOPERIO

Locations

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Studio Cortellini

Florence, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ATRO M-MIST

Identifier Type: -

Identifier Source: org_study_id

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