Teeth ExtractionNCT05047861
Implant Placement in the Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast
A study testing socket shield technique with autogenous dentin graft and socket shield technique with alloplast graft in people with Teeth Extraction and Tooth Socket, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with Bone graft was introduced to preserve the periodontal ligaments related perfusion and preserve socket… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Teeth Extraction, Tooth Socket
- What is being tested?
- socket shield technique with autogenous dentin graft and socket shield technique with alloplast graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 30 Nov 2021
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).
- Intact labial/buccal periodontal tissues.
- Sufficient bone volume to allow placement of an implant.
- Non-Smoker
- Ability to read and sign an informed consent form
Who cannot join
- A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status,current radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
- Untreated periodontal disease. [15,18]
- Vertical root fractures on the buccal aspect. [26]
- Tooth /teeth with horizontal fractures below bone level. [26]
- Tooth /teeth with external or internal resorptions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Evaluation of Implant Placement in Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast (Controlled Clinical and Radiographic Study)
Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with Bone graft was introduced to preserve the periodontal ligaments related perfusion and preserve socket dimensions for new bone formation.
This study aims to compare implants placed in two differently preserved sockets, the first one preserved using Socket Shield technique with Autogenous Dentin Graft while the other socket preserved using socket shield technique with Alloplastic bone graft material
- Conditions
- Teeth Extraction, Tooth Socket
- Being tested
- socket shield technique with autogenous dentin graft, socket shield technique with alloplast graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket shield technique with autogenous dentin graftProcedure or surgery
The crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level.
The root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur.
The lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption.
The coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur.
The socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield.
After the final preparation of the socket shield, Graft will be placed using autogenous dentin graft from the discarded palatal part of the tooth
socket shield technique with alloplast graftProcedure or surgery
The crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level.
The root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur.
The lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption.
The coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur.
The socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield.
After final preparation of socket shield, Graft will be placed Alloplast graft
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | patients will receive the implant in the previously preserved socket using Socket shield technique with Alloplastic graft material Receives: Procedure: socket shield technique with autogenous dentin graft |
| Control group | Active comparator | patients will receive the implant in the previously preserved socket shield with Autogenous dentin graft Receives: Procedure: socket shield technique with alloplast graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
it will be measured using Osstell ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant.
High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
Measured: immeditely and at 3 months
change in bone density
it will be measured using CBCT
Measured: at baseline and 3 months
change in bone height
it will be measured using CBCT
Measured: at baseline and 3 months
change in Labio/Bucco-Palatal width
it will be measured using CBCT
Measured: at 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 posted17 Sep 2021
- Study start1 Dec 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth 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
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
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
- NCT05047861
- Sponsor's protocol ID
- Socket shield_2020
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 17 Sep 2021
- 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 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implant Placement in Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast (Controlled Clinical and Radiographic Study)
- ClinicalTrials.gov ID
- NCT05047861
- Acronym / sponsor ID
- Socket shield_2020
- Conditions
- Teeth Extraction, Tooth Socket
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 17 Sep 2021 (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.
Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with Bone graft was introduced to preserve the periodontal ligaments related perfusion and preserve socket dimensions for new bone formation.
This study aims to compare implants placed in two differently preserved sockets, the first one preserved using Socket Shield technique with Autogenous Dentin Graft while the other socket preserved using socket shield technique with Alloplastic bone graft material
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: socket shield technique with autogenous dentin graftpatients will receive the implant in the previously preserved socket using Socket shield technique with Alloplastic graft material |
| Control group | Active comparator | Procedure: socket shield technique with alloplast graftpatients will receive the implant in the previously preserved socket shield with Autogenous dentin graft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).
- Intact labial/buccal periodontal tissues.
- Sufficient bone volume to allow placement of an implant.
- Non-Smoker
- Ability to read and sign an informed consent form
Key exclusion criteria (5 listed)
- A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status,current radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
- Untreated periodontal disease. [15,18]
- Vertical root fractures on the buccal aspect. [26]
- Tooth /teeth with horizontal fractures below bone level. [26]
- Tooth /teeth with external or internal resorptions.
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 autogenous dentin graftThe crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level. The root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur. The lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption. The coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur. The socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield. After the final preparation of the socket shield, Graft will be placed using autogenous dentin graft from the discarded palatal part of the tooth | Procedure or surgery | Study group |
| socket shield technique with alloplast graftThe crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level. The root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur. The lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption. The coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur. The socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield. After final preparation of socket shield, Graft will be placed Alloplast graft | Procedure or surgery | Control group |
Primary outcome
Change in implant stability
Time frame: immeditely and at 3 months
it will be measured using Osstell ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
change in bone density
Time frame: at baseline and 3 months
it will be measured using CBCT
change in bone height
Time frame: at baseline and 3 months
it will be measured using CBCT
change in Labio/Bucco-Palatal width
Time frame: at baseline and 3 months
it will be measured using CBCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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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 socket shield technique with autogenous dentin graft and socket shield technique with alloplast graft in people with Teeth Extraction and Tooth Socket, 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 5 inclusion and 5 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 17 Sep 2021. 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?
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: immeditely and at 3 months). The study lists 4 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 17 Sep 2021.