Dental ImplantNCT06566287
Immediate and Delayed Implant Placement Using Socket Shield Technique and Autogenous Dentin Graft
A study testing Immediate implant and Delayed implant in people with Dental Implant and Tooth Loss, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
One of the techniques that have been proposed to reduce the amount of bone resorption in anterior maxilla is the "socket shield (SS) ". This technique includes preservation of the facial segment of a root to be extracted and immediate implant placement. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dental Implant, Tooth Loss, Socket Shield
- What is being tested?
- Immediate implant and Delayed implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2023to 19 Dec 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with badly destructed or non-restorable maxillary anterior teeth when the Labial cortical plate is still intact, and the thickness was found to be <2mm in CBCT.
- Patients with health status according to American Society of Anesthesiology (ASA) I and II.
- Patients who agree to participate in the study.
Who cannot join
- Patients presenting with any systemic pathology or health condition that would inhibit the osseointegration process of the implants.
- Perforated labial cortical plate seen in CBCT.
- Patients undergoing radiation therapy or history of radiation within the last two years.
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate And Delayed Implant Placement Using Socket Shield Technique And Autogenous Dentin Graft (A Randomized Clinical Trial)
One of the techniques that have been proposed to reduce the amount of bone resorption in anterior maxilla is the "socket shield (SS) ". This technique includes preservation of the facial segment of a root to be extracted and immediate implant placement. A technique of socket shield with delayed implantation using autogenous dentin graft for socket preservation, as an alternative to autogenous bone grafts, has shown predictable clinical and histological outcomes.
- Conditions
- Dental Implant, Tooth Loss, Socket Shield
- Being tested
- Immediate implant, Delayed implant
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implantOther
Immediate Implant with Socket Shield Group
Delayed implantOther
Delayed Implant with Socket preserved with socket Shield and dentin graft Group
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: Immediate implant |
| Group B | Active comparator | Not described Receives: Other: Delayed implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
The stability of each implant will be measured using the Osstell device. The ISQ value will be measured immediately at the time of surgery and after three months
Measured: Baseline and 3 months
Secondary outcomes (2)
change in thickness of the facial cortical plate
patients will be subjected to CBCT scans
Measured: Baseline and 3 months
Change in bone density
patients will be subjected to CBCT scans
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start17 Jan 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566287
- Sponsor's protocol ID
- 0629-2/2023
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate And Delayed Implant Placement Using Socket Shield Technique And Autogenous Dentin Graft (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06566287
- Acronym / sponsor ID
- 0629-2/2023
- Conditions
- Dental Implant, Tooth Loss, Socket Shield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 22 Aug 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.
One of the techniques that have been proposed to reduce the amount of bone resorption in anterior maxilla is the "socket shield (SS) ". This technique includes preservation of the facial segment of a root to be extracted and immediate implant placement. A technique of socket shield with delayed implantation using autogenous dentin graft for socket preservation, as an alternative to autogenous bone grafts, has shown predictable clinical and histological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Immediate implant |
| Group B | Active comparator | Other: Delayed implant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with badly destructed or non-restorable maxillary anterior teeth when the Labial cortical plate is still intact, and the thickness was found to be <2mm in CBCT.
- Patients with health status according to American Society of Anesthesiology (ASA) I and II.
- Patients who agree to participate in the study.
Key exclusion criteria (4 listed)
- Patients presenting with any systemic pathology or health condition that would inhibit the osseointegration process of the implants.
- Perforated labial cortical plate seen in CBCT.
- Patients undergoing radiation therapy or history of radiation within the last two years.
- Drug or alcohol abuse
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 |
|---|---|---|
| Immediate implantImmediate Implant with Socket Shield Group | Other | Group A |
| Delayed implantDelayed Implant with Socket preserved with socket Shield and dentin graft Group | Other | Group B |
Primary outcome
Change in implant stability
Time frame: Baseline and 3 months
The stability of each implant will be measured using the Osstell device. The ISQ value will be measured immediately at the time of surgery and after three months
2 secondary outcomes
change in thickness of the facial cortical plate
Time frame: Baseline and 3 months
Change in bone density
Time frame: Baseline and 3 months
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 22 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant and Delayed implant in people with Dental Implant and Tooth Loss, run by Hams Hamed Abdelrahman 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 3 inclusion and 4 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 22 Aug 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?
Change in implant stability (time frame: Baseline and 3 months). 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 22 Aug 2024.