10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Procedure: Modified minimally invasive surgery; Procedure: Modified minimally invasive surgery with enamel matrix derivative; Procedure: Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft

• Registration Number: NCT05225142
• Lead Sponsor: The European Research Group on Periodontology (ERGOPerio)

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.

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2009-12-31
• Study Completion: 2020-03-31
• Status Verified: 2022-01
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-03
• Last Update Submitted: 2022-02-03
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical attachment level changes	10 years	Periodontal probing to the nearest millimetre

Secondary Outcome Measures

Name	Time	Method
Probing pocket depts	10 years	Periodontal maintainability
Tooth survival	10 years	Survival of treated teeth - Kaplan Mayer
Complication-free survival	10 years	Survival until first episode of recurrence requiring re-treatment
Cost of recurrence	10 years	Total cost of managing the regretted teeth including treatment of recurrence
Radiographic bone level	10 years	Changes in level of bone supporting the tooth

Trial Locations

Locations (1)

Studio Cortellini; 🇮🇹 Florence, Italy