Dimensional Changes of the Labial Alveolar Ridge After Socket Shield Technique With Computer Guided Root Sectioning

Edentulous Alveolar Ridge Clinical Trial

Official title:

Digital Evaluation of the Early Volumetric Changes of the Labial Alveolar Contour Following Guided Socket Shield Technique for Immediate Implant Placement: A Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366985
• Other study ID #: 07071992
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: May 2022
• Source: Pharos University in Alexandria
• Contact: Ahmed K Nabawy, BDS
• Phone: 01006222775
• Email: ahmadnabawi91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the dimensional changes of the labial alveolar ridge are digitally assessed after immediate implant placement using the socket shield technique with computer guided sectioning of the root.

Description:

Ten hopeless teeth in the esthetic zone were included. A computer guide was used to section the root, leaving the coronal 2/3 of its labial part attached to the socket. An implant was then placed. Preoperative and Postoperative (5 months later) intraoral scans were superimposed with a digital software to assess the dimensional changes of the labial alveolar ridge. Linear changes at 1,3 and 5 mm from the gingival margin and mean linear changes in a specified Area Of Interest (AOI) were measured.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 30, 2022
• Est. primary completion date: July 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• medically healthy patients (ASA 1, ASA 2 categories) ,
• over 18 years old presenting with hopeless teeth due to extensive caries,
• cervical root fracture,
• vertical or oblique root fracture,
• multiple failed endodontic treatments,
• root resorption.

Exclusion Criteria:

• medically compromised patients (the ASA 3, ASA 4 and ASA5 categories)
• vertical root fracture involving the labial aspect of the root that will be retained,
• horizontal fracture of the root that is too far apically located
• presence of acute (active) periapical infection
• lack of sufficient bone to obtain implant primary stability apical and/or palatal to the extraction socket,
• ankylosed tooth which is positioned too apically in relation to the adjacent teeth,
• type 3 extraction sockets according to Elian and Tarnow extraction sockets classification

Related Conditions & MeSH terms

• Dental Trauma
• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Procedure:
• Socket shield technique with computer guided sectioning of the root
A computer guide was used to section the root, leaving the coronal 2/3 of its labial part attached to the socket. An implant was then placed. Preoperative and Postoperative (5 months later) intraoral scans were superimposed with a digital software to assess the dimensional changes of the labial alveolar ridge. Linear changes at 1,3 and 5 mm from the gingival margin and mean linear changes in a specified Area Of Interest (AOI) were measured

Locations

Country	Name	City	State
Egypt	Alexandria university, Faculty of dentistry	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Pharos University in Alexandria	Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dimensional changes of the labial alveolar ridge in orofacial direction in millimeters using GOM Inspect software	Linear changes at 1,3 and 5 mm from the gingival margin and mean linear changes in a specified Area Of Interest (AOI) were measured.	5 months
Primary	Thickness of the labial plate of bone in millimeters on the preoperative CBCT radiograph	On the preoperative CBCT scan, the thickness of the labial plate of bone was measured at the thickest part of its coronal third.The labial plate of bone was also checked for the presence of any radiographic coronal dehiscence and/or apical perforation by the root apex.	Preoperative