The Influence of the Topical Combined Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate on Implant Osseointegration: A Split-Mouth Randomized Clinical Trial.

Background: Immediate dental implant placement into extraction sockets offers reduced treatment time and favorable patient outcomes. Achieving early implant stability and predictable osseointegration is essential for long-term success. This study aimed to evaluate whether a topical combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate could enhance early implant stability in humans. The trial was designed as a randomized split-mouth superiority study comparing test implants treated with the osteogenic inducer (OI) to control implants placed under identical surgical conditions. Methods: This split-mouth randomized clinical trial included 18 systemically healthy adults requiring two adjacent or contralateral implants in the same jaw. All surgeries were performed at the Department of Oral and Maxillofacial Surgery, Al-Azhar University-Gaza. Each participant received one test implant (with a gelatin sponge saturated with the OI) and one control implant (with a plain gelatin sponge). Allocation of test and control sites was determined using centralized computer-generated randomization. The primary outcome was the implant stability, assessed using the Implant Stability Quotient (ISQ) at baseline and after 4, 8, and 16 weeks. Outcome assessment was performed by an examiner blinded to group allocation. Results: At 4 weeks, the test group demonstrated significantly higher ISQ values (70.19 ± 6.31) than the control group (65.35 ± 4.23; Conclusion: The first-in-human clinical study investigating this topical osteogenic combination demonstrated a measurable short-term benefit in enhancing early implant stability. Although the effect did not persist at later time points during the 16-week follow-up period, the findings suggest that this biological adjunct may support accelerated healing during the early phase of osseointegration. Trial Registration: ClinicalTrials.gov identifier: NCT07060859.