Immediate ImplantNCT06700486
Assessment of the Socket Shield Technique Accompanied by Sticky Bone Around the Immediate Implant
A study testing SOCKET SHIELD and Immediate implant and sticky bone in people with Immediate Implant, run by Reham Qabeel at 1 site in Egypt.
Trial summary
challenge of the implant of esthetic zone with buccal plate of bone width less than 2mm become available by the using of socket shield technique used with the immediate implant this technique provide improvement of the width of buccal plate of bone which improve esthetic outcome bot the jumping gape still a… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant
- What is being tested?
- SOCKET SHIELD and Immediate implant and sticky bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Patients having at least single tooth into esthetic zone indicated for extraction and immediate implant placement.
- 2. patient with adequate oral hygiene and systemically free. 3.patients' age ranging from 20-60 years. 4. Free from any systemic disease according to Cornell Medical Index
Who cannot join
- 1. Presence of para-functional habits such as bruxism, clenching, excessive gum chewing, lip or fingernail biting.
- 2. Chronic smokers or formal smoker. 3.Insulin dependent diabetes 4.Thyroid disease 5.Clinical diagnosis of Alzheimer's Disease 6. patients receiving chemotherapy or radiotherapy, alcohol or drug abuse 7. Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Assessment of the Socket Shield Technique Accompanied by Sticky Bone Around the Immediate Implant
challenge of the implant of esthetic zone with buccal plate of bone width less than 2mm become available by the using of socket shield technique used with the immediate implant this technique provide improvement of the width of buccal plate of bone which improve esthetic outcome bot the jumping gape still a questionable area between the shield and the implant which required to be filled with biological filling to improve osteointegration and stability of the implant such as sticky bone ,bone mixed with injectable PRF , PRF also has antibacterial ,anti-inflammatory effect and regenerative effect which could help.
Read the detailed description
Biological mechanisms involved in the healing of the periodontal tissues after tooth extraction can cause the loss of the periodontal ligament and its vascular support. The physiological process can lead to esthetic problems that are difficult to resolve by methods of restoration that are able to preserve the emergence profile, especially in the anterior region . Therefore, preserving and maintaining the bone anatomy and soft tissue architecture in the anterior region is essential for maintaining esthetics restorations .
Teeth extractions basis volumetric changes characterized by alveolar bone resorption, specifically the buccal plate of bone, with a consequential associated soft tissue retraction . Several studies proved that buccal dimension of the alveolar ridge undergoes horizontal bone resorption of about 56% and a resorption of the palatal /lingual bone of 30% through the interval four-month prior extraction of the tooth. Correspondingly . detected overall horizontal dimension resorption of the alveolar ridge subsequent the extraction, and the buccal wall reduction of the alveolar ridge is more obvious than lingual wall .
Immediate placement of implant does not totally overcome the resorption of the alveolar bone and recession of the soft tissue in esthetic region following teeth extractions. Loss of alveolar bone prior extraction consider as irreversible process concerning both vertical and horizontal resorption. Moreover, the alveolar bone resorption is more distinct on the buccal wall than on the lingual wall of the extraction socket.
The ridge dimension is reduced when implants are placed immediately without subsequent directed bone regeneration treatments. When compared to spontaneous healing, it appears to be ineffective at around half of the initial bone width in horizontal dimension . By using a grafting substance and combining instantaneous implant insertion with a guided bone-regeneration process, less horizontal bone resorption can be expected .
Several augmentation techniques are used in the surgical field to create sufficient bone volume. Grafting techniques for particulate bone augmentation include autograft, allograft, xenograft, and alloplast. Autograft is the gold standard in bone augmentation, but it has drawbacks such as second surgical-site morbidity and insufficient bone volume. Secondary infections are a disadvantage of allografts and xenografts Since 2010, a novel method of producing growth factor-enriched bone graft matrix (also known as sticky bone) with autologous fibrin glue has been demonstrated. Sticky bone stabilizes the bone graft in the defect, accelerating tissue healing and minimizing bone loss during the healing period. It is moldable and adaptable to a variety of bony defects, preventing micro and macro movement of the grafted bone. As a result, the volume of the augmentation is maintained during the healing process, and the need of titanium mesh and bone block is reduced .
In contrast to PRP or PRGF, the fibrin network entraps platelets and leukocytes to release growth factors, speeding up soft tissue regeneration and bone regeneration. Furthermore, unlike PRP or PRGF, no biochemical additives are required to make sticky bone, and fibrin interconnection reduces soft tissue ingrowth into the sticky bone graft .
Studies revealed that the presence of vascular supply from the periodontal ligament was a major factor in the preservation of alveolar bone and soft tissues, the idea of leaving the leftover root section on the labial plate was advocated. This procedure is known as "socket shield technology" in which the root fragment acts as a shield to protect the buccal bone from resorption
- Conditions
- Immediate Implant
- Being tested
- SOCKET SHIELD, Immediate implant and sticky bone
- Keywords
- socket shield, sticky bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCKET SHIELDProcedure or surgery
in implant dentistry
Immediate implant and sticky boneProcedure or surgery
in implant dentistry
| Study group | Role | What they receive |
|---|---|---|
| comparator arm | Active comparator | Immediate implant and sticky bone Receives: Procedure: SOCKET SHIELD |
| interventional arm | Other | Socket shield Receives: Procedure: Immediate implant and sticky bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue thickness
measured with mm
Measured: 6 months
Marginal bone loss
measured with mm
Measured: 9 months
Secondary outcomes (3)
Buccal bone width
width measured with mm
Measured: 6 and 9 months
Buccal bone length
length measured with mm
Measured: 6 and 9 months
Bone density
Bone density measured with Hounsfield index
Measured: 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start12 Mar 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Qabeel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Qabeel, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700486
- Sponsor's protocol ID
- P-ME-22-02
- Status last verified
- Nov 2024
- First submitted
- 31 Jul 2022
- Last updated
- 22 Nov 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of the Socket Shield Technique Accompanied by Sticky Bone Around the Immediate Implant
- ClinicalTrials.gov ID
- NCT06700486
- Acronym / sponsor ID
- P-ME-22-02
- Conditions
- Immediate Implant
- Keywords
- socket shield, sticky bone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Reham QabeelUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Nov 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.
challenge of the implant of esthetic zone with buccal plate of bone width less than 2mm become available by the using of socket shield technique used with the immediate implant this technique provide improvement of the width of buccal plate of bone which improve esthetic outcome bot the jumping gape still a questionable area between the shield and the implant which required to be filled with biological filling to improve osteointegration and stability of the implant such as sticky bone ,bone mixed with injectable PRF , PRF also has antibacterial ,anti-inflammatory effect and regenerative effect which could help.
Detailed description
Biological mechanisms involved in the healing of the periodontal tissues after tooth extraction can cause the loss of the periodontal ligament and its vascular support. The physiological process can lead to esthetic problems that are difficult to resolve by methods of restoration that are able to preserve the emergence profile, especially in the anterior region . Therefore, preserving and maintaining the bone anatomy and soft tissue architecture in the anterior region is essential for maintaining esthetics restorations .
Teeth extractions basis volumetric changes characterized by alveolar bone resorption, specifically the buccal plate of bone, with a consequential associated soft tissue retraction . Several studies proved that buccal dimension of the alveolar ridge undergoes horizontal bone resorption of about 56% and a resorption of the palatal /lingual bone of 30% through the interval four-month prior extraction of the tooth. Correspondingly . detected overall horizontal dimension resorption of the alveolar ridge subsequent the extraction, and the buccal wall reduction of the alveolar ridge is more obvious than lingual wall .
Immediate placement of implant does not totally overcome the resorption of the alveolar bone and recession of the soft tissue in esthetic region following teeth extractions. Loss of alveolar bone prior extraction consider as irreversible process concerning both vertical and horizontal resorption. Moreover, the alveolar bone resorption is more distinct on the buccal wall than on the lingual wall of the extraction socket.
The ridge dimension is reduced when implants are placed immediately without subsequent directed bone regeneration treatments. When compared to spontaneous healing, it appears to be ineffective at around half of the initial bone width in horizontal dimension . By using a grafting substance and combining instantaneous implant insertion with a guided bone-regeneration process, less horizontal bone resorption can be expected .
Several augmentation techniques are used in the surgical field to create sufficient bone volume. Grafting techniques for particulate bone augmentation include autograft, allograft, xenograft, and alloplast. Autograft is the gold standard in bone augmentation, but it has drawbacks such as second surgical-site morbidity and insufficient bone volume. Secondary infections are a disadvantage of allografts and xenografts Since 2010, a novel method of producing growth factor-enriched bone graft matrix (also known as sticky bone) with autologous fibrin glue has been demonstrated. Sticky bone stabilizes the bone graft in the defect, accelerating tissue healing and minimizing bone loss during the healing period. It is moldable and adaptable to a variety of bony defects, preventing micro and macro movement of the grafted bone. As a result, the volume of the augmentation is maintained during the healing process, and the need of titanium mesh and bone block is reduced .
In contrast to PRP or PRGF, the fibrin network entraps platelets and leukocytes to release growth factors, speeding up soft tissue regeneration and bone regeneration. Furthermore, unlike PRP or PRGF, no biochemical additives are required to make sticky bone, and fibrin interconnection reduces soft tissue ingrowth into the sticky bone graft .
Studies revealed that the presence of vascular supply from the periodontal ligament was a major factor in the preservation of alveolar bone and soft tissues, the idea of leaving the leftover root section on the labial plate was advocated. This procedure is known as "socket shield technology" in which the root fragment acts as a shield to protect the buccal bone from resorption
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comparator arm | Active comparator | Procedure: SOCKET SHIELDImmediate implant and sticky bone |
| interventional arm | Other | Procedure: Immediate implant and sticky boneSocket shield |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Patients having at least single tooth into esthetic zone indicated for extraction and immediate implant placement.
- 2. patient with adequate oral hygiene and systemically free. 3.patients' age ranging from 20-60 years. 4. Free from any systemic disease according to Cornell Medical Index
Key exclusion criteria (2 listed)
- 1. Presence of para-functional habits such as bruxism, clenching, excessive gum chewing, lip or fingernail biting.
- 2. Chronic smokers or formal smoker. 3.Insulin dependent diabetes 4.Thyroid disease 5.Clinical diagnosis of Alzheimer's Disease 6. patients receiving chemotherapy or radiotherapy, alcohol or drug abuse 7. Pregnancy and lactation.
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 SHIELDin implant dentistry | Procedure or surgery | comparator arm |
| Immediate implant and sticky bonein implant dentistry | Procedure or surgery | interventional arm |
Primary outcome
Soft tissue thickness
Time frame: 6 months
measured with mm
Marginal bone loss
Time frame: 9 months
measured with mm
3 secondary outcomes
Buccal bone width
Time frame: 6 and 9 months
Buccal bone length
Time frame: 6 and 9 months
Bone density
Time frame: 6 and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 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 SOCKET SHIELD and Immediate implant and sticky bone in people with Immediate Implant, run by Reham Qabeel 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
Soft tissue thickness (time frame: 6 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 22 Nov 2024.