NCT06574815

Effects of the SIS Membrane on GBR and Early Loading of Maxillary Anterior Dental Implants

Evaluation of the Effects of the Small Intestine Submucosa (SIS) Biological Membrane on Guided Bone Regeneration (GBR) and Early Loading of Dental Implants in the Maxillary Anterior Region

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Beijing Stomatological Hospital, Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients were randomized into three groups at a 1:1:1 ratio, including the GBR with a Bio-Gide membrane and delayed implant loading (Gide-DL) group, the GBR with a Bio-Gide membrane and early implant loading (Gide-EL) group, and the GBR with an SIS membrane and early implant loading (SIS-EL) group. The allocation sequence was generated through an online tool (www. random.org) and was concealed in sealed envelopes. At 6 weeks after implant and GBR surgery, the implant stability quotient (ISQ) was measured and recorded at the labial, palatal, mesial, and distal locations via the Osstell device in the Gide-EL group and the SIS-EL group. If the ISQ was ≥ 65, definitive restoration (early loading) was performed (if \< 65, the subject was withdrawn from the trial). The digital impressions and occlusal relationships were obtained via intraoral scanning, and the implant-supported crown was designed based on the digital model. Titanium base abutments with angled screw channels (ASCs) and porcelain veneered zirconia (PVZ) crowns were used for restoration. Immediately after definitive restoration, intraoral scanning was used to record the soft tissue contour at the implant site, and CBCT was used to examine the bone tissue around the implant. In addition, patients in the Gide-DL group underwent definitive restoration at 6 months after surgery (delayed loading), and the treatment process was the same as that in the Gide-EL and SIS-EL groups at 6 weeks after surgery. Clinical examination, intraoral scanning, imageological diagnosis, and aesthetic scoring were used to determine the clinical effect of SIS membranes and early implant loading at 1-year follow-up.

Conditions

• Dental Implantation
• Guided Bone Regeneration

Interventions

Type	Name	Description
PROCEDURE	Early implant loading	Patients underwent definitive restoration at 6 weeks after implant surgery (early loading).
PROCEDURE	Delayed implant loading	Patients underwent definitive restoration at 6 months after implant surgery (delayed loading).
PROCEDURE	GBR using an SIS membrane	An small intestine submucosa (SIS) membrane was used in the guided bone regeneration (GBR) surgery.
PROCEDURE	GBR using an Bio-Gide membrane	An Bio-Gide membrane was used in the guided bone regeneration (GBR) surgery.

Timeline

• Start date: 2023-04-30
• Primary completion: 2024-08-02
• Completion: 2024-08-16
• First posted: 2024-08-28
• Last updated: 2024-08-30

Locations

1 site across 1 country: China