Edentulous Alveolar RidgeNCT05366985
Dimensional Changes of the Labial Alveolar Ridge After Socket Shield Technique With Computer Guided Root Sectioning
A study testing Socket shield technique with computer guided sectioning of the root in people with Edentulous Alveolar Ridge and Dental Trauma, run by Pharos University in Alexandria at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge, Dental Trauma
- What is being tested?
- Socket shield technique with computer guided sectioning of the root
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 30 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university, Faculty of dentistry
Alexandria, 21519
Ahmed K Nabawi, BDS, 01006222775 ext. +2, ahmadnabawi91@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Edentulous Alveolar Ridge, Dental Trauma
- Being tested
- Socket shield technique with computer guided sectioning of the root
- Keywords
- Bone implant interactions, Periodontology,, Soft tissue-implant interactions, Surgical techniques, Wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket shield technique with computer guided sectioning of the rootProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Socket shield technique with computer guided sectioning of the root |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Sep 2021
- Primary completion3 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Ahmed Khaled Sameh Nabawi, Pharos University in Alexandria
- Investigators
- Ahmed K Nabawy, BDS, Principal investigator, Alexandria university, Faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366985
- Sponsor's protocol ID
- 07071992
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be available at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05366985
- Acronym / sponsor ID
- 07071992
- Conditions
- Edentulous Alveolar Ridge, Dental Trauma
- Keywords
- Bone implant interactions, Periodontology,, Soft tissue-implant interactions, Surgical techniques, Wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 3 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 10 May 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Socket shield with guided root sectioning | Experimental | Procedure: Socket shield technique with computer guided sectioning of the rootTooth extraction and immediate implant placement using the socket shield technique with computer guided sectioning of the root. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Socket shield technique with computer guided sectioning of the rootA 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 | Procedure or surgery | Socket shield with guided root sectioning |
Primary outcome
dimensional changes of the labial alveolar ridge in orofacial direction in millimeters using GOM Inspect software
Time frame: 5 months
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
Time frame: Preoperative
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: Yes. All collected IPD will be available at the end of the study
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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.
Ahmed K Nabawy, BDS principal investigator
Alexandria university, Faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket shield technique with computer guided sectioning of the root in people with Edentulous Alveolar Ridge and Dental Trauma, run by Pharos University in Alexandria at 1 site in Egypt.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed K Nabawy, BDS (01006222775 ext. +2, ahmadnabawi91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dimensional changes of the labial alveolar ridge in orofacial direction in millimeters using GOM Inspect software (time frame: 5 months). 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?
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 11 May 2022.