The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites

Not Applicable

Completed

• Conditions: Immediate Implants
• Interventions: Procedure: Non-staged vestibular fresh socket therapy

• Registration Number: NCT03987646
• Lead Sponsor: Nourhan M.Aly

Brief Summary

This article aims to provide a non- staged treatment protocol to placing dental implants in compromised fresh sockets in the aesthetic zone.

Detailed Description

This is a site-specific therapy uses study a slowly resorbing regenerative barrier (shield) to augment any thin or deficient labial plate of bone, enhances the overlying soft tissue quality and quantity at the same time with implant fixture placement using a computer-guided surgical template.

Study Timeline

• Study Start: 2018-05-24
• Primary Completion: 2019-06-10
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-17
• Study Completion: 2019-08-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• A hopeless single tooth in the maxillary anterior region
• Sufficient apical bone to allow adequate anchorage/primary stability of the implant
• had natural teeth present adjacent to the tooth being replaced

Exclusion Criteria

• Presence of acute infection
• Impossibility of reaching adequate implant primary stability in the native
• Smokers of > 10 cigarettes
• Antitumor chemotherapy or radiotherapy in the previous year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
xenograft cortical flexible sheet	Non-staged vestibular fresh socket therapy	a-traumatic tooth removal , socket lavage and curettage, performing a vestibular access horizontal incision corresponding to the socket 3-4 mm apically from the muccogingival junction , a tunnel is then created from the socket office and extended apically till it connects with the vestibular access incision, a computer guided surgical template is then used to deliver the implant in its optimal position, a slowly resorbable membrane shield is then introduced through the tunnel and stabilized with a membrane tac , it is a sturdy fixable membrane barrier placed above the labial plate

Primary Outcome Measures

Name	Time	Method
radiographic buccal bone height	6 months	preoperative and follow up CBCTs are superimposed on each other and buccal bone height is measured in relation to implant shoulder level
radiographic buccal bone thickness	6 months	preoperative and follow up CBCTs are superimposed on each other and buccal bone thickness is measure at 3 similar points on both CBCTs and then a mean is calculated

Secondary Outcome Measures

Name	Time	Method
final esthetic outcome of soft tissue	6 months	Pink esthetic score. based on subjective assessment of mesial papilla, distal papilla, midfacial level, midfacial contour, alveolar process deficiency, soft tissue color and texture. each item is given a score between 0 and 2, where 0 is the worst and 2 is the best outcome. Then, a final score ranging between 0-14 is calculated

Trial Locations

Locations (1)

Private Practice Clinic; 🇪🇬 Alexandria, Egypt