Implant stability and clinical outcome between implant placement using internal sinus floor elevation with alloplastic bone material grafting and without grafting: A 1-year randomized clinical trial

Objective

To compare implant stability and clinical outcome in implant placement between osteotome sinus floor elevation (OSFE) with biphasic calcium phosphate (BCP) which consisted of 30% of hydroxyapatite (HA) and 70% of beta-tricalcium phosphate (β -TCP) grafting material and OSFE without using bone grafting material. The research questions is whether the BCP provides any benefit in OSFE or not.

Materials and methods

Thirty patients (30 implants) with a single edentulous area of upper premolar or molar were randomly separated into OSFE with BCP (n = 15) and OSFE without grafting (n = 15). The patients were reevaluated 3, 6, 9, and 12 months after implant loading. The clinical assessments (implant stability quotient (ISQ), implant survival-failure rate, and surgical complication) were analyzed. Together with radiographic assessments in 2D (endo-sinus bone gain (ESBG), mean marginal bone change (MMBC)) and 3D (endo-sinus bone gain in CBCT (ESBG-CT)) were evaluated, with a mean follow-up time of at least 12 months of functional loading and prosthetic complication.

Results

20 remaining implants (OSFE with BCP, n = 10; OSFE without grafting, n = 10) were analyzed. Mean ISQ was 79.18 \(\pm\) $\pm$ 3.43 in 1-year follow-up (ISQ; OSFE with BCP = 78.72 \(\pm\) $\pm$ 3.46, OSFE without grafting = 79.65 \(\pm\) $\pm$ 3.52). ISQ in both groups increased steadily without significant differences in each follow-up. (p = 0.56). In radiographic evaluation, at 6-, 9-, and 12-month, OSFE without grafting group showed statistically significant lower MMBC (p < 0.05). The 1-year clinical results showed that 2 implants failed in OSFE with BCP, and 1 implant failed in OSFE without grafting.

Conclusions

Graft material “BCP” (HA30:TCP70) coupled with OSFE presents no extraordinary benefit in implant stability, clinical and radiographic outcome in 1-year follow-up.

Clinical relevance

Clinically, OSFE with grafting materials provides no additional benefit.

Clinical trial registration number: TCTR20210517008 (date of registration: May 17, 2021)