Marginal Bone Loss in Socket Shield TechniqueNCT03394625
Evaluate Marginal B. Loss in Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Versus Xenograft
A study testing Socket shield technique and using Xenograft material in people with Marginal Bone Loss in Socket Shield Technique, run by Cairo University at 1 site in Egypt.
Trial summary
Anterior maxilla (Esthetic zone) is very challenging area because of thin buccal plate of bone. After tooth extraction physiological process occur causing alteration of bone and soft tissue so, delayed placement of implant lead to loss of bone height and width. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Marginal Bone Loss in Socket Shield Technique
- What is being tested?
- Socket shield technique and using Xenograft material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 20 Dec 2018
- 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
- Patients with badly broken teeth in upper esthetic zone with intact periodontal condition indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- Physically able to tolerate conventional surgical and restorative procedures.
- Signing of an informed consent form.
Who cannot join
- Presence of fenestrations or dehiscence of the residual bony walls after extraction.
- Heavy smokers more than 20 cigarettes per day .(24)
- Patients with systemic disease that may affect normal healing e.g. uncontrolled diabetes.
- Psychiatric problems e.g. severe bruxism.
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
- Active infection in the teeth to be treated
- Vertical root fractures with displacement in the teeth of the surgical area
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
faculty of oral and dental medicine cairo university, (+202) 23634965, dentmail@dentistry.cu.edu.eg
information department cairo university, (+202) 23634965, info@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Marginal Bone Loss in Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique Versus Xenogenous Bone Substitute Material
Anterior maxilla (Esthetic zone) is very challenging area because of thin buccal plate of bone. After tooth extraction physiological process occur causing alteration of bone and soft tissue so, delayed placement of implant lead to loss of bone height and width. Immediate placement of implant is become essential to preserve the bone and soft tissue from loss.
Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket. This technique allow preservation of buccal plate of bone and soft tissue with minimum loss allowing better result in esthetic zone.
- Being tested
- Socket shield technique, using Xenograft material
- Keywords
- Socket Shield, immediate implant, ridge preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket shield techniqueProcedure or surgery
Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket.
using Xenograft materialProcedure or surgery
placing xenograft material in gap between the implant and the buccal plate of bone
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement using socket shield technique | Experimental | Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket. Receives: Procedure: Socket shield technique |
| immediate implant placement using xenograft material | Active comparator | placing xenograft material in gap between implant and buccal bone Receives: Procedure: using Xenograft material |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone loss
will be measured from CBCT using Blue-sky software built-in linear measuring tool by millimeters
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Jul 2017
- Primary completion1 Nov 2018 (estimated)
- Study completion20 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone Loss in Socket Shield TechniqueStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ibrahim Shaalan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394625
- Sponsor's protocol ID
- Shaalancuimplant
- Status last verified
- Sep 2018
- First submitted
- 27 Dec 2017
- Last updated
- 7 Sep 2018
- 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 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Marginal Bone Loss in Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique Versus Xenogenous Bone Substitute Material
- ClinicalTrials.gov ID
- NCT03394625
- Acronym / sponsor ID
- Shaalancuimplant
- Keywords
- Socket Shield, immediate implant, ridge preservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 20 Dec 2018 (estimated)
- First posted
- 9 Jan 2018 (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.
Anterior maxilla (Esthetic zone) is very challenging area because of thin buccal plate of bone. After tooth extraction physiological process occur causing alteration of bone and soft tissue so, delayed placement of implant lead to loss of bone height and width. Immediate placement of implant is become essential to preserve the bone and soft tissue from loss.
Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket. This technique allow preservation of buccal plate of bone and soft tissue with minimum loss allowing better result in esthetic zone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement using socket shield technique | Experimental | Procedure: Socket shield techniqueSocket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket. |
| immediate implant placement using xenograft material | Active comparator | Procedure: using Xenograft materialplacing xenograft material in gap between implant and buccal bone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with badly broken teeth in upper esthetic zone with intact periodontal condition indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- Physically able to tolerate conventional surgical and restorative procedures.
- Signing of an informed consent form.
Key exclusion criteria (7 listed)
- Presence of fenestrations or dehiscence of the residual bony walls after extraction.
- Heavy smokers more than 20 cigarettes per day .(24)
- Patients with systemic disease that may affect normal healing e.g. uncontrolled diabetes.
- Psychiatric problems e.g. severe bruxism.
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
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 techniqueSocket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket. | Procedure or surgery | immediate implant placement using socket shield technique |
| using Xenograft materialplacing xenograft material in gap between the implant and the buccal plate of bone | Procedure or surgery | immediate implant placement using xenograft material |
Primary outcome
marginal bone loss
Time frame: 4 months
will be measured from CBCT using Blue-sky software built-in linear measuring tool by millimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
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.
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 and using Xenograft material in people with Marginal Bone Loss in Socket Shield Technique, run by Cairo University 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 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 7 Sep 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal bone loss (time frame: 4 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 7 Sep 2018.