- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06658860
Alveolar Ridge Changes Post Tooth Extraction With Socket Shield Without Immediate Implant Placement" (CBCT)
October 24, 2024 updated by: Soaad Tolba Mohammed Tolba Badawi
Dimensional Changes of Alveolar Ridge After Tooth Extraction Using the Socket Shield Technique Without Immediate Implant Placement.
This study aimed to evaluate the dimensional changes in the alveolar ridge after tooth extraction using the socket shield technique without immediate implant placement.
The changes using CBCT were assessed, focusing on the preservation of the ridge for delayed implant placement.
This research could help improve dental implant outcomes by preserving bone and soft tissue structures."
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
"In this clinical trial, the dimensional changes in the alveolar ridge following tooth extraction were investigated using the socket shield technique.
The socket shield technique involved partial retention of the root structure to preserve the surrounding bone and soft tissues.
No immediate implant placement was performed, and the ridge changes were assessed at multiple time points through CBCT scans.
The study included a specified sample size, and participants underwent a follow-up of 6 months after socket shield preparation.
This research aimed to provide insights into how well the socket shield technique preserves ridge dimensions over time, potentially optimizing future implant stability."
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahlia
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Mansoura, Dakahlia, Egypt, 35511
- Faculty of Dentistry, Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Non-restorable teeth in the esthetic region.
- The buccal periodontal tissues were intact.
- Maintaining oral hygiene.
Exclusion Criteria:
- The usual limitations for oral surgery.
- Tooth having a vertical fracture of the root on the facial aspect.
- Tooth having horizontal fracture of the root extending below the level of the bone.
- Caries on the root segment to be maintained.
- Mobility of the tooth.
- Bruxism.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modified Socket Shield Technique
Participants in this group underwent partial tooth extraction using the modified socket shield technique to preserve the alveolar ridge for delayed implant placement.
CBCT scans were used to evaluate ridge preservation over time.
|
The modified socket shield technique involves partial retention of the buccal aspect of the tooth root during extraction to preserve the surrounding alveolar bone and soft tissue.
This technique is used to optimize the condition for delayed implant placement by preventing resorption of the alveolar ridge.
|
|
Active Comparator: Conventional Tooth Extraction
Participants in this group underwent conventional tooth extraction without the socket shield technique.
The alveolar ridge was evaluated using CBCT over the same period as the experimental group for comparison.
|
Conventional tooth extraction involves the complete removal of the tooth without the use of the socket shield technique.
This arm served as the control group, with alveolar ridge changes observed and compared with those in the experimental arm over time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar Ridge Width Changes
Time Frame: 6 months post-extraction
|
This outcome measure assesses changes in the alveolar ridge width following tooth extraction using either the modified socket shield technique or conventional extraction.
Measurements were obtained through CBCT imaging at baseline and 6 months post-extraction.
Unit of Measure: Millimeters (mm)
|
6 months post-extraction
|
|
Bone Plate Height Changes
Time Frame: 6 months post-extraction
|
This outcome measure assesses changes in the bone plate height following tooth extraction using either the modified socket shield technique or conventional extraction.
Measurements were obtained through CBCT imaging at baseline and 6 months post-extraction.
Unit of Measure: Millimeters (mm)
|
6 months post-extraction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Implant Stability
Time Frame: At the time of implant placement, typically 6 months post-extraction.
|
This outcome measure assessed the primary stability of dental implants placed after using either the socket shield technique or conventional extraction.
Implant stability was evaluated using resonance frequency analysis (RFA) at the time of implant placement."
|
At the time of implant placement, typically 6 months post-extraction.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Soaad T Badawi, Lecturer, Oral Surgery, MU, Faculty of Dentistry, Mansoura University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
August 1, 2024
Study Registration Dates
First Submitted
October 22, 2024
First Submitted That Met QC Criteria
October 24, 2024
First Posted (Actual)
October 26, 2024
Study Record Updates
Last Update Posted (Actual)
October 26, 2024
Last Update Submitted That Met QC Criteria
October 24, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- A27030123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The individual participant data (IPD) will not be shared due to privacy concerns and the confidential nature of patient data.
Additionally, the current study protocol does not include provisions for external data sharing."
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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