Effects of the SIS Membrane on GBR and Early Loading of Maxillary Anterior Dental Implants
NCT Number: NCT06574815
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implantation|Guided Bone Regeneration
Interventions: PROCEDURE: Early implant loading|PROCEDURE: Delayed implant loading|PROCEDURE: GBR using an SIS membrane|PROCEDURE: GBR using an Bio-Gide membrane
Sponsor: Beijing Stomatological Hospital, Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-30
Completion Date: 2024-08-16
Locations: Beijing Stomatological Hospital, Capital Medical University, Beijing, China

Summary:
The aim of this randomized controlled trial (RCT) is to determine whether early implant loading that shortens the healing period to 6 weeks can be safely and effectively applied to implants with good initial stability in the maxillary anterior region, which undergoes simultaneous guided bone regeneration (GBR), via clinical examination, intraoral scanning, imageological diagnosis, and aesthetic scoring, and to determine the clinical effect of the small intestine submucosa (SIS) biological barrier membrane in such cases involving early loading. This study is expected to provide preliminary guidance on the timing of loading for a single maxillary anterior implant with insufficient bone volume and provide a theoretical basis for the selection of a biological barrier membrane for GBR in such patients.

Primary Outcome Measures: Soft tissue contour assessment, Intraoral scanning was used to collect the soft tissue contour at the implant site, the contour of the implant-supported crown and adjacent natural teeth. The preoperative, immediate postoperative, and 1-year follow-up intraoral scanning data in stereolithography (STL) formats were imported into Exocad 3.0 software. The best-fit images of the median sagittal section at the implant site were extracted, and the horizontal contour changes (HCCs) were measured at 1 mm and 3 mm below the crown-gingiva margin. The preoperative contour was used as the baseline to detect the immediate postoperative horizontal contour increase (HCI), and the immediate postoperative contour was used as another baseline to detect the 1-year follow-up horizontal contour decrease (HCD)., At the 1-year follow-up|Marginal bone level assessment, X-ray images immediately postoperative (baseline) and at the 1-year follow-up were taken, and the distances from the most coronal bone-to-implant or bone-to-superstructure contact point to the reference point (neck margin of the implant) were measured at the mesial and distal sides of the implant; then, the data were averaged. Negative values were recorded when the contact point was at the root side of the reference point, and positive values were recorded when the contact point was at the crown side of the reference point. The data were calibrated with the known length of the implant to correct for distortion. The MBL changes were obtained by subtracting the baseline data from the 1-year follow-up data., At the 1-year follow-up