Alveolar Ridge Resorption After ExtractionCBCTNCT06658860

Alveolar Ridge Changes Post Tooth Extraction With Socket Shield Without Immediate Implant Placement"

A study testing Modified Socket Shield Technique and Conventional Tooth Extraction in people with Alveolar Ridge Resorption After Extraction, run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Alveolar Ridge Resorption After Extraction
What is being tested?: Modified Socket Shield Technique and Conventional Tooth Extraction
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteEgypt
Study dates: 1 Feb 2023to 1 Aug 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-restorable teeth in the esthetic region.
The buccal periodontal tissues were intact.
Maintaining oral hygiene.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

Official title: Dimensional Changes of Alveolar Ridge After Tooth Extraction Using the Socket Shield Technique Without Immediate Implant Placement.

Read the 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."

Conditions: Alveolar Ridge Resorption After Extraction
Being tested: Modified Socket Shield Technique, Conventional Tooth Extraction
Keywords: Tooth Extraction, Modified Socket Shield Technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified Socket Shield TechniqueProcedure or surgery
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.
Conventional Tooth ExtractionProcedure or surgery
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.

Study groups in NCT06658860
Study group	Role	What they receive
Modified Socket Shield Technique	Experimental	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. Receives: Procedure: Modified Socket Shield Technique
Conventional Tooth Extraction	Active comparator	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. Receives: Procedure: Conventional Tooth Extraction

What is being measured

The primary outcome is the main question the study is designed to answer.

Alveolar Ridge Width Changes
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)
Measured: 6 months post-extraction
Bone Plate Height Changes
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)
Measured: 6 months post-extraction

Secondary outcomes (1)

Primary Implant Stability
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."
Measured: At the time of implant placement, typically 6 months post-extraction.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20231 Aug 2024

First posted26 Oct 2024
Study start1 Feb 2023
Primary completion1 Jul 2024
Study completion1 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alveolar Ridge Resorption After ExtractionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study followed a parallel-group design. Participants were randomly assigned to two groups: one received the modified socket shield technique and the other received conventional extraction without the socket shield. Both groups were monitored after 6 months to compare alveolar ridge preservation outcomes, with delayed implant placement performed in both groups at 6 months after tooth extraction.
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06658860
Sponsor's protocol ID: A27030123
Acronym: CBCT
Status last verified: Oct 2024
First submitted: 22 Oct 2024
Last updated: 26 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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."

Publications

de Oliveira GB, Rebello IMC, Montanha Andrade K, Araujo NS, Dos Santos JN, Cury PR. Evaluation of alveolar process resorption after tooth extraction using the socket shield technique without immediate installation of implants: a randomised controlled clinical trial. Br J Oral Maxillofac Surg. 2021 Dec;59(10):1227-1232. doi: 10.1016/j.bjoms.2021.04.001. Epub 2021 Apr 8.
PubMed 34256958

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Volumetric Efficacy of Alveolar Ridge Preservation
Alveolar Ridge Preservation, Tooth Loss
Recruiting
THBC/CGF for Alveolar Bone Regeneration: A Real-World Study
Alveolar Bone Loss, Alveolar Ridge Resorption After Extraction
Recruiting
Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Bone Loss
Recruiting
Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
Alveolar Bone Loss
Not yet recruiting
Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix)
Tooth Loss / Rehabilitation, Tooth Extraction

All Alveolar Ridge Resorption After Extraction trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dimensional Changes of Alveolar Ridge After Tooth Extraction Using the Socket Shield Technique Without Immediate Implant Placement.
ClinicalTrials.gov ID: NCT06658860
Acronym / sponsor ID: CBCT / A27030123
Conditions: Alveolar Ridge Resorption After Extraction
Keywords: Tooth Extraction, Modified Socket Shield Technique
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Soaad Tolba Mohammed Tolba BadawiUniversity, hospital or other
Study start: 1 Feb 2023 (actual)
Primary completion: 1 Jul 2024 (actual)
Study completion: 1 Aug 2024 (actual)
First posted: 26 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This study followed a parallel-group design. Participants were randomly assigned to two groups: one received the modified socket shield technique and the other received conventional extraction without the socket shield. Both groups were monitored after 6 months to compare alveolar ridge preservation outcomes, with delayed implant placement performed in both groups at 6 months after tooth extraction.

Arm	Type	Receives
Modified Socket Shield Technique	Experimental	Procedure: Modified Socket Shield TechniqueParticipants 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.
Conventional Tooth Extraction	Active comparator	Procedure: Conventional Tooth ExtractionParticipants 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Non-restorable teeth in the esthetic region.
The buccal periodontal tissues were intact.
Maintaining oral hygiene.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Modified Socket Shield TechniqueThe 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.	Procedure or surgery	Modified Socket Shield Technique
Conventional Tooth ExtractionConventional 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.	Procedure or surgery	Conventional Tooth Extraction

Primary outcome

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)
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)

1 secondary outcome

Primary Implant Stability
Time frame: At the time of implant placement, typically 6 months post-extraction.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Background: PubMed 34256958de Oliveira GB, Rebello IMC, Montanha Andrade K, Araujo NS, Dos Santos JN, Cury PR. Evaluation of alveolar process resorption after tooth extraction using the socket shield technique without immediate installation of implants: a randomised controlled clinical trial. Br J Oral Maxillofac Surg. 2021 Dec;59(10):1227-1232. doi: 10.1016/j.bjoms.2021.04.001. Epub 2021 Apr 8.
Individual participant dataSharing planned: No. 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."

Related trials for Alveolar Ridge Resorption After Extraction

Recruiting
Volumetric Efficacy of Alveolar Ridge Preservation
Alveolar Ridge Preservation, Tooth Loss
Recruiting
THBC/CGF for Alveolar Bone Regeneration: A Real-World Study
Alveolar Bone Loss, Alveolar Ridge Resorption After Extraction
Recruiting
Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Bone Loss
Recruiting
Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
Alveolar Bone Loss
Not yet recruiting
Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix)
Tooth Loss / Rehabilitation, Tooth Extraction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Soaad T Badawi, Lecturer, Oral Surgery, MU principal investigator

Faculty of dentistry, Mansoura university

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alveolar Ridge Width Changes (time frame: 6 months post-extraction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06658860, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.