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

Immediate Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987646
• Other study ID #: nonstaged socket therapy
• Status: Completed
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: August 8, 2019

Study information

• Verified date: September 2019
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 8, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Immediate Implants

Intervention

Procedure:
• Non-staged vestibular fresh socket therapy
a slowly resorbable membrane shield is placed above the labial plate of bone so that when the thin labial plate started its resorption process the shield remains till a complete gap fill occurred thus leading to a thicker labial plate of bone or it preserves the socket architecture until a complete bone fill occurred inside the socket

Locations

Country	Name	City	State
Egypt	Private Practice Clinic	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Barroso-Panella A, Gargallo-Albiol J, Hérnandez-Alfaro F. Evaluation of Bone Stability and Esthetic Results After Immediate Implant Placement Using a Novel Synthetic Bone Substitute in the Anterior Zone: Results After 12 Months. Int J Periodontics Restorative Dent. 2018 Mar/Apr;38(2):235-243. doi: 10.11607/prd.2863. — View Citation

Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217. Review. — View Citation

Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3. Review. — View Citation

Meijer HJA, Slagter KW, Vissink A, Raghoebar GM. Buccal bone thickness at dental implants in the maxillary anterior region with large bony defects at time of immediate implant placement: A 1-year cohort study. Clin Implant Dent Relat Res. 2019 Feb;21(1):73-79. doi: 10.1111/cid.12701. Epub 2018 Dec 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic buccal bone thickness	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	6 months
Primary	radiographic buccal bone height	preoperative and follow up CBCTs are superimposed on each other and buccal bone height is measured in relation to implant shoulder level	6 months
Secondary	final esthetic outcome of soft tissue	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	6 months