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

NCT05366985 | Unknown

• 1 other identifier: 07071992
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edentulous Alveolar Ridge; Dental Trauma

Keywords

Bone implant interactions; Periodontology,; Soft tissue-implant interactions; Surgical techniques; Wound healing

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Socket shield with guided root sectioning

EXPERIMENTAL

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

Interventions

Socket shield technique with computer guided sectioning of the root PROCEDURE

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

Socket shield with guided root sectioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharos University in Alexandria: lead
• Alexandria University: collaborator

Study Sites (1)

Alexandria university, Faculty of dentistry

Alexandria, 21519, Egypt

RECRUITING

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Ahmed K Nabawy, BDS

  Alexandria university, Faculty of dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed K Nabawy, BDS

CONTACT

01006222775; ahmadnabawi91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 10, 2022
• Study Start: September 1, 2021
• Primary Completion: July 3, 2022
• Study Completion: July 30, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• 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.

Locations

EG (1)