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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Trauma; Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: Socket shield technique with computer guided sectioning of the root

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed K Nabawy, BDS; Phone Number: +2 01006222775; Email: ahmadnabawi91@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt, 21519
    • Recruiting
    • Alexandria University, Faculty of dentistry
    • Contact: Ahmed K Nabawi, BDS; Phone Number: +2 01006222775; Email: ahmadnabawi91@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Socket shield with guided root sectioning; Tooth extraction and immediate implant placement using the socket shield technique with computer guided sectioning of the root.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Pharos University in Alexandria
• Collaborators: Alexandria University
• Investigators: Principal Investigator: Ahmed K Nabawy, BDS, Alexandria University, Faculty of dentistry

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): July 3, 2022
• Study Completion (ANTICIPATED): July 30, 2022

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (ACTUAL): May 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Wound healing; Surgical techniques; Bone implant interactions; Periodontology,; Soft tissue-implant interactions
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 07071992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD will be available at the end of the study
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: Requests to access IPD should be sent to the principal investigator by e-mail. All collected IPD will be sent to the other researchers by e-mail upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No