10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

The European Research Group on Periodontology (ERGOPerio)

Status: Completed

Conditions: Periodontitis

Treatments: Procedure: Modified minimally invasive surgery with enamel matrix derivative; Procedure: Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft; Procedure: Modified minimally invasive surgery

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05225142

ATRO M-MIST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Modified minimally invasive surgery alone

Experimental group

Description:

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

Treatment:

Procedure: Modified minimally invasive surgery

Modified minimally invasive surgery with enamel matrix derivative

Active Comparator group

Description:

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

Treatment:

Procedure: Modified minimally invasive surgery

Procedure: Modified minimally invasive surgery with enamel matrix derivative

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

Active Comparator group

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)

Treatment:

Procedure: Modified minimally invasive surgery

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

Procedure: Modified minimally invasive surgery with enamel matrix derivative