Evaluation of the effects of the small intestine submucosa biological membrane on guided bone regeneration and early loading of dental implants in the maxillary anterior region: A randomized controlled trial.

Abstract

Statement of problem: Whether an early loading strategy can be applied to a single maxillary anterior implant with insufficient bone volume is debatable. Moreover, the clinical effect of using a small intestine submucosa (SIS) biological membrane in guided bone regeneration (GBR) surgery in such clinical scenarios is unclear.

Purpose: The purpose of this randomized controlled trial was to determine the effectiveness and safety of an early loading strategy for patients who have undergone dental implant placement and GBR surgery for a missing maxillary anterior tooth and to clarify the effects of SIS membranes.

Material and methods: Thirty-six study participants were randomly assigned into 3 groups: the GBR with a resorbable non-crosslinked porcine collagen membrane (Bio-Gide) and delayed implant loading (Gide-DL) group, the GBR with a resorbable non-crosslinked porcine collagen membrane (Bio-Gide) and early implant loading (Gide-EL) group, and the GBR with an SIS membrane and early implant loading (SIS-EL) group. The degree of implant torque was ≥35 Ncm. Definitive restorations were completed 6 months after surgery in the Gide-DL group and 6 weeks after surgery in the Gide-EL and SIS-EL groups. Clinical examination, intraoral scanning, radiograph examination, and white and pink esthetic scoring was performed at the 1-year follow-up to evaluate the implant survival rate, peri-implant conditions, soft tissue contour changes, marginal bone resorption, and esthetics. Data with a normal distribution and homogeneous variance were analyzed via 1-way analysis of variance (ANOVA) and the least significant difference (LSD) multiple comparison test. Data without a normal distribution or homogeneous variance were analyzed via the Kruskal-Wallis H test and Bonferroni multiple comparison test (α=.05 for all tests).

Results: No implant failures or significant differences in the probing depth, plaque index, or bleeding index among the 3 groups were detected at the 1-year follow-up. There was no significant difference in the soft tissue contour change among the 3 groups. Only the changes at 1 mm apical to the crown-gingival connecting margin in the SIS-EL group were significantly lower than those in the Gide-EL and Gide-DL groups (P<.05). The marginal bone levels and white and pink esthetic scores were not significantly different among the 3 groups (P>.05).

Conclusions: The early loading strategy is suitable for patients who have undergone dental implant placement and GBR for a missing maxillary anterior tooth with good primary stability, and favorable clinical effects can be achieved with the use of SIS membranes.