Enamel Matrix Derivative in the Reconstructive Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial.

Aims: To evaluate the adjunctive effect of enamel matrix derivative (EMD) in the reconstructive surgical therapy of peri-implantitis.

Methods: Forty subjects (44 implants) affected by peri-implantitis (PPD ≥ 5 mm, positive BOP/SOP, intraosseous defect with a depth of ≥ 3 mm and width of ≤ 4 mm) were randomly allocated to one of two surgical protocols: control (access flap + bone graft + resorbable membrane) or test (access flap + bone graft + resorbable membrane + EMD). Clinical outcomes (PPD, BOP, SOP, buccal REC, and buccal KM) were assessed at baseline, 6 and 12 months after surgery. Radiographic marginal bone levels (MBL) and patient-reported outcomes (PROs) were recorded at baseline and at 12 months. Post-operative complications and Early Healing Index (EHI) scores were recorded at 2 weeks. The primary outcome was PPD change. Two composite outcomes (CO) were assessed: CO1 was defined as "implant not lost, PPD ≤ 5 mm, REC ≤ 1 mm and complete absence of BOP/SOP"; CO2 defined as CO1 but allowing for 1 site with BOP.

Results: Four patients (four implants) were lost to follow-up. At 12 months, no implants were lost, 73% of implants presented with PPD ≤ 5 mm (control: 65.2%; test: 81.0%; p = 0.316) and PPD reduction amounted to 4.0 ± 1.7 and 4.3 ± 2.4 mm in control and test groups, respectively (p = 0.105). No significant differences in terms of clinical, radiographic, composite and PROs were observed between groups. No significant differences in EHI scores were found at 2 weeks between groups.

Conclusion: This study failed to demonstrate any benefit of the adjunctive use of EMD in the reconstructive surgical therapy of peri-implantitis.

Trial registration: ISRCTN18159776 (https://doi.org/10.1186/ISRCTN18159776).