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

ABSTRACT 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 )