Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574815
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Effects of the SIS Membrane on GBR and Early Loading of Maxillary Anterior Dental Implants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 111 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 randomorg 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group and the SIS-EL group If the ISQ was 65 definitive restoration early loading was performed if 65 the subject was withdrawn from the trial The digital impressions and occlusal relationships were obtained via intraoral scanning and the implant-supported crown was designed based on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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None