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

Primary Purpose

Edentulous Alveolar Ridge, Dental Trauma

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Socket shield technique with computer guided sectioning of the root

About this trial

This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring Bone implant interactions, Periodontology,, Soft tissue-implant interactions, Surgical techniques, Wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Alexandria university, Faculty of dentistryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Socket shield with guided root sectioning

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05366985

First Posted

May 2, 2022

Last Updated

May 9, 2022

Sponsor

Pharos University in Alexandria

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05366985

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

July 3, 2022 (Anticipated)

Study Completion Date

July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pharos University in Alexandria

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous Alveolar Ridge, Dental Trauma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Socket shield with guided root sectioning

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Socket shield technique with computer guided sectioning of the root

Intervention Description

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

Primary Outcome Measure Information:

Title

dimensional changes of the labial alveolar ridge in orofacial direction in millimeters using GOM Inspect software

Description

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.

Time Frame

5 months

Title

Thickness of the labial plate of bone in millimeters on the preoperative CBCT radiograph

Description

Time Frame

Preoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed K Nabawy, BDS

Phone

01006222775

Ext

ahmadnabawi91@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed K Nabawy, BDS

Organizational Affiliation

Alexandria university, Faculty of dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alexandria university, Faculty of dentistry

City

Alexandria

ZIP/Postal Code

21519

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed K Nabawi, BDS

Phone

01006222775

Ext

ahmadnabawi91@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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