Clinical, Radiographic and Patient‐Centred Outcomes of MINST Versus MIST With Enamel Matrix Derivative in Class II Mandibular Furcation Defects: A Randomised Controlled Trial
TL;DR
MINST with EMD showed clinical and radiographic outcomes generally comparable to MIST in mandibular Class II furcation defects, and was associated with significantly improved short‐term PROMs during the early healing phase.
Abstract
ABSTRACT Aims To evaluate whether minimally invasive non‐surgical therapy (MINST) with flapless application of enamel matrix derivative (EMD) achieves non‐inferior clinical and radiographic outcomes compared to minimally invasive surgical technique (MIST) + EMD, while improving patient‐reported outcome measures (PROMs). Materials and Methods Following CONSORT guidelines, 40 patients with mandibular Grade II furcation defects were randomised to MINST (n = 20) or MIST (n = 20) with EMD. Probing pocket depth (PPD), clinical attachment level (CAL) and cone‐beam computed tomography (CBCT) horizontal/vertical bone loss were assessed at baseline and 9 months. PROMs (visual analogue score [VAS] and Oral Health Impact Profile [OHIP‐14]) were recorded longitudinally. Results At 9 months, the mean PPD reduction was 2.20 ± 2.24 mm in the MIST group and 2.15 ± 1.76 mm in the MINST group. The adjusted mean difference was −0.22 mm (95% CI: −1.43 to 0.99 mm). The one‐sided non‐inferiority p‐value was 0.025. As the upper bound of the confidence interval remained below the prespecified non‐inferiority margin, MINST was considered non‐inferior to MIST for the primary outcome. When evaluated against the strict +1.0 mm margin, MINST achieved statistical non‐inferiority for gingival recession (p = 0.003) and vertical bone gain (p = 0.015). However, non‐inferiority could not be formally established for CAL (p = 0.067) or horizontal bone gain (p = 0.157). PROMs revealed significantly lower root hypersensitivity and improved oral‐health‐related quality of life in the MINST group at 2 weeks; however, these differences were not sustained at later timepoints. Conclusions Within the limitations of this randomised controlled trial, MINST with EMD showed clinical and radiographic outcomes generally comparable to MIST in mandibular Class II furcation defects. While non‐inferiority against a strict 1.0 mm margin was successfully established for the primary outcome (PPD) and specific secondary parameters, it could not be formally confirmed for CAL or horizontal bone gain. MINST was associated with significantly improved short‐term PROMs during the early healing phase. Trial Registration ClinicalTrials.gov identifier: NCT05541614