Crestal Bone LossNCT03264053
Socket Shield Technique Versus Conventional Immediate Implant Placement in Thin Buccofacial Bone
A study testing Socket shield and Conventional immediate implantation in people with Crestal Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Buccal bone is prone to resorb after tooth extraction specially with immediate tooth implantation which could compromise the esthetics of the patient. socket shield technique retains the buccal aspect of the extracted root fragment which may help in preventing the buccal bone from resorbing and prevent esthetics… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Crestal Bone Loss
- What is being tested?
- Socket shield and Conventional immediate implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2017to 1 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Humans
- Esthetic area (anterior and first premolars)
- Intact labial plate
- Hopeless tooth indicated for extraction and immediate implant placement
Who cannot join
- • Implantation after trauma
- Peri-implantits defects
- Use of barrier membranes(GBR)
- Socket preservation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo
Ahmad el khadem, lecturer, 00201227520298, hassan.ahmed@dentistry.cu.edu.eg
About this study
Official title: Socket Shield Technique Versus Conventional Immediate Implant Placement in Thin Buccofacial Bone to Evaluate Buccal Bone Resorption: A Randomized Controlled Trial
Buccal bone is prone to resorb after tooth extraction specially with immediate tooth implantation which could compromise the esthetics of the patient. socket shield technique retains the buccal aspect of the extracted root fragment which may help in preventing the buccal bone from resorbing and prevent esthetics deterioration
Read the detailed description
The alveolar ridge resorbs and collapses following tooth removal which continues to be a major concern for practitioners. Many researchers concluded that buccal aspect of the ridge is more prone to resorption, as it is primarily supplied by the periodontal tissues and ligments of the tooth. Therefore, extraction of the hopeless tooth, may be a reason for buccal cortical plate resorbing at a faster rate than the palatal plate leading to its total degradation. This may lead to dimensional changes in the human ridge and the aesthetic area is highly affected by this process. Several techniques in the litreture were proposed to solve the problem of thin buccal bone resorption with or without immediate implantation in the aesthetic area. Some of these techniques are the guided bone and soft tissue regenraton and bone augmentation but proved to be slight aggressive with high morbidity rate. Recently, several papers were published concerning the socket shield technique explaining how to maintain the ridge width and height. Socket shield technique that was first introduced in 2010 aids at retaining the buccal fragment of root in place and intact thus placing the implant behind the lingual aspect of that fragment so that the periodontal ligments and tissues preserve its vitality and aids in preventing the collapsing of the buccal bone. This would help in improving aesthetics especially during immediate implant placment in the anterior maxillary region.
- Conditions
- Crestal Bone Loss
- Being tested
- Socket shield, Conventional immediate implantation
- Keywords
- socket shield technique, crestal bone loss, immediate implanation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket shieldDevice
Also called Implant stability
Socket shield is the Removal of the lingual portion of the anterior root thus retaining the lingual portion
Conventional immediate implantationProcedure or surgery
Conventional immediate implantation
| Study group | Role | What they receive |
|---|---|---|
| SOCKET SHIELD TECHNIQUE | Experimental | Socket shield is the surgical removal of the frontal aspect of the badly broken root and retaining the lingual aspect so as to prevent crestal bone loss with insertion of the dental implant behind it Receives: Device: Socket shield |
| Conventional immediate implantation | Active comparator | Conventional immediate implantation is the surgical removal of the entire badly broken root Receives: Procedure: Conventional immediate implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal bone resorption assesed by cone beam computed tomography as a measuring tool
Measuring buccal bone loss after the procedure comparing between leaving the buccal portion of the root and extracting the whole root
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start20 Aug 2017
- Primary completion20 Aug 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crestal Bone LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Abdou Mattar, Cairo University
- Investigators
- Abdullah A Mattar, A.Lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264053
- Sponsor's protocol ID
- CEBD-CU-2017-08-03
- Status last verified
- Sep 2017
- First submitted
- 16 Aug 2017
- Last updated
- 15 Sep 2017
- 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 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Shield Technique Versus Conventional Immediate Implant Placement in Thin Buccofacial Bone to Evaluate Buccal Bone Resorption: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03264053
- Acronym / sponsor ID
- CEBD-CU-2017-08-03
- Conditions
- Crestal Bone Loss
- Keywords
- socket shield technique, crestal bone loss, immediate implanation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 20 Aug 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 28 Aug 2017 (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.
Buccal bone is prone to resorb after tooth extraction specially with immediate tooth implantation which could compromise the esthetics of the patient. socket shield technique retains the buccal aspect of the extracted root fragment which may help in preventing the buccal bone from resorbing and prevent esthetics deterioration
Detailed description
The alveolar ridge resorbs and collapses following tooth removal which continues to be a major concern for practitioners. Many researchers concluded that buccal aspect of the ridge is more prone to resorption, as it is primarily supplied by the periodontal tissues and ligments of the tooth. Therefore, extraction of the hopeless tooth, may be a reason for buccal cortical plate resorbing at a faster rate than the palatal plate leading to its total degradation. This may lead to dimensional changes in the human ridge and the aesthetic area is highly affected by this process. Several techniques in the litreture were proposed to solve the problem of thin buccal bone resorption with or without immediate implantation in the aesthetic area. Some of these techniques are the guided bone and soft tissue regenraton and bone augmentation but proved to be slight aggressive with high morbidity rate. Recently, several papers were published concerning the socket shield technique explaining how to maintain the ridge width and height. Socket shield technique that was first introduced in 2010 aids at retaining the buccal fragment of root in place and intact thus placing the implant behind the lingual aspect of that fragment so that the periodontal ligments and tissues preserve its vitality and aids in preventing the collapsing of the buccal bone. This would help in improving aesthetics especially during immediate implant placment in the anterior maxillary region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOCKET SHIELD TECHNIQUE | Experimental | Device: Socket shieldSocket shield is the surgical removal of the frontal aspect of the badly broken root and retaining the lingual aspect so as to prevent crestal bone loss with insertion of the dental implant behind it |
| Conventional immediate implantation | Active comparator | Procedure: Conventional immediate implantationConventional immediate implantation is the surgical removal of the entire badly broken root |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Humans
Key exclusion criteria (4 listed)
- • Implantation after trauma
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 shieldAlso: Implant stabilitySocket shield is the Removal of the lingual portion of the anterior root thus retaining the lingual portion | Device | SOCKET SHIELD TECHNIQUE |
| Conventional immediate implantationConventional immediate implantation | Procedure or surgery | Conventional immediate implantation |
Primary outcome
Buccal bone resorption assesed by cone beam computed tomography as a measuring tool
Time frame: 12 months
Measuring buccal bone loss after the procedure comparing between leaving the buccal portion of the root and extracting the whole root
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
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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.
Abdullah A Mattar, A.Lecturer principal investigator
Cairo University
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 and Conventional immediate implantation in people with Crestal Bone Loss, 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 4 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: status not confirmed, as of the sponsor's last update on 15 Sep 2017. 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 Abdullah A Mattar, A. Lecturer (00201010022987, dr_abdullah.mattar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal bone resorption assesed by cone beam computed tomography as a measuring tool (time frame: 12 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 15 Sep 2017.