Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295055
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-28
Brief Title:
Semi-rigid Shell Barrier System for Alveolar Bone Augmentation SSBS for ABA
Sponsor:
Prince of Songkla University
Organization:
Prince of Songkla University
Study Overview
Official Title:
Evaluation of Clinical Outcomes of the Semi-rigid Shell Barrier System for Alveolar Bone Augmentation
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSBS for ABA
Brief Summary:
This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation Participants with bone defects between 3 to 8 millimeters moderate to severe bone defect will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement
Detailed Description:
Inclusion criteria are subjects requiring a bone defect between 3 to 8 millimeters moderate to severe bone defect covered 1-2 tooth span with adjacent tooth planned for dental implant and fixed prosthesis aged 20 and above but under the age of 65 with good physical health and good oral hygiene able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment and available for follow-up after implant placement
Exclusion criteria are subjects in following reasons i Heavy smokers 10 cigarettesday ii receiving bisphosphonates iii undergoing radiotherapy iv uncontrolled medical conditions v Alcoholism vi Pregnancy Bone augmentation procedure Before surgery patients will be premedication with 1000 mg of amoxicillin antibiotic and rinse chlorhexidine mouthwash 012 concentration for 1 minute A single oral and maxillofacial surgeon will perform all surgical procedures Local anesthesia with 4 Articaine hydrochloride with epinephrine 1 100000 Septanest Septodont France will be administered to each patient for inferior alveolar nerve block or local infiltration A full thickness mucoperiosteal flap will be created and the actual defect size will be measured with a periodontal probe following the flap procedure Flap advancement with periosteal releasing flap decorticate the bone with a round bur then apply the semi-rigid shell and fix it with ti-tacks or screws Following that xenograft a bone graft material will be placed and ti-tacks will be used to fix the semi-resorbable covering membrane Lastly tension-free flap closure with double layer suturing technique which is a horizontal mattress and interrupts suture
Exclusion criteria are subjects in following reasons i Heavy smokers 10 cigarettesday ii receiving bisphosphonates iii undergoing radiotherapy iv uncontrolled medical conditions v Alcoholism vi Pregnancy Bone augmentation procedure Before surgery patients will be premedication with 1000 mg of amoxicillin antibiotic and rinse chlorhexidine mouthwash 012 concentration for 1 minute A single oral and maxillofacial surgeon will perform all surgical procedures Local anesthesia with 4 Articaine hydrochloride with epinephrine 1 100000 Septanest Septodont France will be administered to each patient for inferior alveolar nerve block or local infiltration A full thickness mucoperiosteal flap will be created and the actual defect size will be measured with a periodontal probe following the flap procedure Flap advancement with periosteal releasing flap decorticate the bone with a round bur then apply the semi-rigid shell and fix it with ti-tacks or screws Following that xenograft a bone graft material will be placed and ti-tacks will be used to fix the semi-resorbable covering membrane Lastly tension-free flap closure with double layer suturing technique which is a horizontal mattress and interrupts suture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None