Immediate Dental Implantssocket shieldNCT06881095
Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone
A study testing socket shield technique group (study group) and conventional immediate implant without socket shield technique in people with Immediate Dental Implants and Thin Labial Plate of Bone Pre-extraction, run by Tanta University at 1 site in Egypt.
Trial summary
20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation using either the immediate implant with socket shield technique or the conventional immediate dental implant. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implants, Thin Labial Plate of Bone Pre-extraction, Hopeless Tooth in Esthetic Zone
- What is being tested?
- socket shield technique group (study group) and conventional immediate implant without socket shield technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2024to 16 Jun 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Non restorable maxillary anterior teeth without periapical pathology that may affect the success of dental implants.
- 2. Interarch space enough for prosthetic rehabilitation. 3. Presence of posterior teeth or prosthesis that maintain occlusal bite. 4. Adult patients. 5. Good oral hygiene.
Who cannot join
- 1. Edentulous anterior maxillary region. 2. Bad oral hygiene. 3. Patients with any relevant systemic diseases that affect soft tissue or bone healing.
- 4. Patients with parafunctional habits (bruxism and clenching). 5. Uncooperative patients. 6. Heavy smokers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation using either the immediate implant with socket shield technique or the conventional immediate dental implant.
the socket shield technique group (study group): 10 patients will have immediate implant placement with the socket shield technique.
- conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique.
Read the detailed description
20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation randomized to two groups immediate dental implant with the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique.
- conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique. preparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.
The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe.
After completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted palatal to the SS.
- Conditions
- Immediate Dental Implants, Thin Labial Plate of Bone Pre-extraction, Hopeless Tooth in Esthetic Zone
- Being tested
- socket shield technique group (study group), conventional immediate implant without socket shield technique
- Keywords
- socket shield technique, partial extraction therapy, immediate dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket shield technique group (study group)Procedure or surgery
Also called partial extraction therapy
immediate implant installation with socket shield technique: After administration of local anesthesia, the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds.
Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.
The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants, and the root section was checked for immobility with a sharp probe.
After completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer
conventional immediate implant without socket shield techniqueProcedure or surgery
- After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months.
| Study group | Role | What they receive |
|---|---|---|
| socket shield technique group (study group) | Experimental | the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique.
* conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique.
preparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.
The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe.
After completion of th Receives: Procedure: socket shield technique group (study group) |
| conventional immediate implant without socket shield technique(control group) | Experimental | conventional immediate implant without socket shield technique:
• After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months. Receives: Procedure: conventional immediate implant without socket shield technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
labial bone thickness
- labial bone thickness measuring thickness of labial bone labial to the implant by (CBCT) Cone beam computed tomography
Measured: 6 months
marginal bone loss
Measured: 6 months
Secondary outcomes (3)
bone density around dental implant
bone density around dental implant by Cone beam computed tomography
Measured: 6 months
implant secondary stability
Secondary implant stability: will be recorded just after uncovery using Resonance frequency analysis (RFA) device * (Osstell).
Measured: 6 months
implant success
absence of infection, fistula formation or implant mobility
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start25 Mar 2024
- Primary completion12 May 2025 (estimated)
- Study completion16 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental ImplantsStudies 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
- Model description
- non restorable anterior teeth with thin labial plate of bone
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Ahmed Elsayed, Tanta University
- Investigators
- islam ahmed abo elela, master study, Principal investigator, faculty of dentistry tanta universityIbrahim mohammed nowair, professor, Principal investigator, faculty of dentistry tanta universityRafic ramadan bedir, professor, Principal investigator, faculty of dentistry tanta universityWesam Hamed Elsaadany, lecturer, Principal investigator, faculty of dentistry tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881095
- Sponsor's protocol ID
- islam123
- Acronym
- socket shield
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone
- ClinicalTrials.gov ID
- NCT06881095
- Acronym / sponsor ID
- socket shield / islam123
- Conditions
- Immediate Dental Implants, Thin Labial Plate of Bone Pre-extraction, Hopeless Tooth in Esthetic Zone
- Keywords
- socket shield technique, partial extraction therapy, immediate dental implant
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 12 May 2025 (estimated)
- Study completion
- 16 Jun 2025 (estimated)
- First posted
- 18 Mar 2025 (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.
20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation using either the immediate implant with socket shield technique or the conventional immediate dental implant.
the socket shield technique group (study group): 10 patients will have immediate implant placement with the socket shield technique.
- conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique.
Detailed description
20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation randomized to two groups immediate dental implant with the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique.
- conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique. preparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.
The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe.
After completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted palatal to the SS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- non restorable anterior teeth with thin labial plate of bone
| Arm | Type | Receives |
|---|---|---|
| socket shield technique group (study group) | Experimental | Procedure: socket shield technique group (study group)the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique. * conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique. preparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe. After completion of th |
| conventional immediate implant without socket shield technique(control group) | Experimental | Procedure: conventional immediate implant without socket shield techniqueconventional immediate implant without socket shield technique: • After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Non restorable maxillary anterior teeth without periapical pathology that may affect the success of dental implants.
- 2. Interarch space enough for prosthetic rehabilitation. 3. Presence of posterior teeth or prosthesis that maintain occlusal bite. 4. Adult patients. 5. Good oral hygiene.
Key exclusion criteria (2 listed)
- 1. Edentulous anterior maxillary region. 2. Bad oral hygiene. 3. Patients with any relevant systemic diseases that affect soft tissue or bone healing.
- 4. Patients with parafunctional habits (bruxism and clenching). 5. Uncooperative patients. 6. Heavy smokers.
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 group (study group)Also: partial extraction therapyimmediate implant installation with socket shield technique: After administration of local anesthesia, the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds. Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants, and the root section was checked for immobility with a sharp probe. After completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer | Procedure or surgery | socket shield technique group (study group) |
| conventional immediate implant without socket shield technique• After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months. | Procedure or surgery | conventional immediate implant without socket shield technique(control group) |
Primary outcome
labial bone thickness
Time frame: 6 months
1. labial bone thickness measuring thickness of labial bone labial to the implant by (CBCT) Cone beam computed tomography
marginal bone loss
Time frame: 6 months
3 secondary outcomes
bone density around dental implant
Time frame: 6 months
implant secondary stability
Time frame: 6 months
implant success
Time frame: 6 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 18 Mar 2025.
- Individual participant dataSharing planned: No
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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.
islam ahmed abo elela, master study principal investigator
faculty of dentistry tanta university
Ibrahim mohammed nowair, professor principal investigator
faculty of dentistry tanta university
Rafic ramadan bedir, professor principal investigator
faculty of dentistry tanta 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 technique group (study group) and conventional immediate implant without socket shield technique in people with Immediate Dental Implants and Thin Labial Plate of Bone Pre-extraction, run by Tanta 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 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: enrolling by invitation, as of the sponsor's last update on 18 Mar 2025. 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?
labial bone 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 18 Mar 2025.