Socket ShieldNCT06590168
Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets
A study testing Socket Preservation by vestibular socket therapy and Socket Preservation by icecream cone technique in people with Socket Shield and Socket Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Shield, Socket Preservation
- What is being tested?
- Socket Preservation by vestibular socket therapy and Socket Preservation by icecream cone technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 1 Apr 2025
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults from the age of 18 - 60 years Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar Type II sockets will be selected as revealed by Cone beam computed tomography (CBCT).
- Intact gingival tissue with at least 2mm keratinized tissue Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index . Patients accepts to provide informed consent
Who cannot join
- Pregnant and lactating females. Smokers as smoking is a contraindication for any plastic periodontal surgery. Patients with BOP\>15%. Patients with periodontal diseases . Handicapped and mentally retarded patients. Patients undergoing radiotherapy. Presence of systemic disease that would affect wound healing. Presence of active infection with soft tissue communication.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, Giza Governorate, 4240101
About this study
Official title: Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone.
Read the detailed description
The aim of this randomized clinical trial is to assess the volumetric and radiographic ridge contour changes following alveolar ridge preservation using Vestibular socket preservation in patient with type II fresh extraction sockets, versus ice cream cone technique.
In patients needing extraction in anterior maxilla with type II sockets, there will be no difference between the Vestibular socket preservation and ice cream cone technique regarding the changes in alveolar ridge contour.
- Conditions
- Socket Shield, Socket Preservation
- Being tested
- Socket Preservation by vestibular socket therapy, Socket Preservation by icecream cone technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket Preservation by vestibular socket therapyProcedure or surgery
Subperiosteal tunnel will be created from the facial aspect of the socket orifice and extending apically until the extent of the vestibular access incision. A cortical shield will be introduced from the vestibular incision through the tunnel and the Socket will be filled by xenograft . Apical cut will be made at the palatal aspect to free the pedicle flap connective tissue and the pedicle flap will be raised using periosteal elevator and rotated and rolled occlusally to seal the socket and sutured using interrupted sutures . The primary palatal flap will be sutured in place over the donor site palatally using interrupted sutures.
Socket Preservation by icecream cone techniqueProcedure or surgery
Collagen barrier membrane will be shaped as an ice cream cone and placed in the extraction socket lining the buccal tissues. The socket will be filled with Demineralized Bovine Bone Matrix DBBM.The upper part of the membrane will be used to cover the socket and will be stabilized by interrupted sutures using prolene sutures of size 6-0
| Study group | Role | What they receive |
|---|---|---|
| intervention Vestibular Socket Preservation for socket preservation | Experimental | Not described Receives: Procedure: Socket Preservation by vestibular socket therapy |
| ice cream cone technique for socket preservation | Active comparator | Not described Receives: Procedure: Socket Preservation by icecream cone technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear buccal distance (mm)
Soft tissue linear buccal distance will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark)
Measured: 6 months
Secondary outcomes (4)
Changes in the height of the socket buccal and palatal ridges (mm)
Radiographic assessment using Cone Beam Computed Tomography to assess the labiopalatal alveolar ridge width reduction and changes in the height of the socket buccal and lingual ridges. Cone Beam Computed Tomography (CBCT) (Carestream Health, CS 8100 3D System) will be performed preoperative, baseline and 6 months postoperative.
Measured: 6 months
Labiopalatal volumetric ridge contour analysis (mm)
Labiopalatal volumetric ridge contour analysis will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark) and scans will be superimposed on each other.
Measured: 6 months
Patient satisfaction (Yes/No)
Patient satisfaction will be evaluated using questionnaires during the 2 weeks after ARP.
Measured: 2 weeks
Pain (1-10)
The severity of subjective pain and swelling will be evaluated using the visual analog scale (VAS) score (score range = 0-10, with 0 reflecting no pain and swelling), and durations of pain and swelling will be investigated during the 2 weeks after ARP
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jul 2024
- Primary completion15 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket ShieldStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed Fouad Shemais, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590168
- Sponsor's protocol ID
- AAN.2
- Status last verified
- Apr 2025
- First submitted
- 3 Sep 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06590168
- Acronym / sponsor ID
- AAN.2
- Conditions
- Socket Shield, Socket Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 19 Sep 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.
Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone.
Detailed description
The aim of this randomized clinical trial is to assess the volumetric and radiographic ridge contour changes following alveolar ridge preservation using Vestibular socket preservation in patient with type II fresh extraction sockets, versus ice cream cone technique.
In patients needing extraction in anterior maxilla with type II sockets, there will be no difference between the Vestibular socket preservation and ice cream cone technique regarding the changes in alveolar ridge contour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention Vestibular Socket Preservation for socket preservation | Experimental | Procedure: Socket Preservation by vestibular socket therapy |
| ice cream cone technique for socket preservation | Active comparator | Procedure: Socket Preservation by icecream cone technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults from the age of 18 - 60 years Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar Type II sockets will be selected as revealed by Cone beam computed tomography (CBCT).
- Intact gingival tissue with at least 2mm keratinized tissue Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index . Patients accepts to provide informed consent
Key exclusion criteria (1 listed)
- Pregnant and lactating females. Smokers as smoking is a contraindication for any plastic periodontal surgery. Patients with BOP\>15%. Patients with periodontal diseases . Handicapped and mentally retarded patients. Patients undergoing radiotherapy. Presence of systemic disease that would affect wound healing. Presence of active infection with soft tissue communication.
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 Preservation by vestibular socket therapySubperiosteal tunnel will be created from the facial aspect of the socket orifice and extending apically until the extent of the vestibular access incision. A cortical shield will be introduced from the vestibular incision through the tunnel and the Socket will be filled by xenograft . Apical cut will be made at the palatal aspect to free the pedicle flap connective tissue and the pedicle flap will be raised using periosteal elevator and rotated and rolled occlusally to seal the socket and sutured using interrupted sutures . The primary palatal flap will be sutured in place over the donor site palatally using interrupted sutures. | Procedure or surgery | intervention Vestibular Socket Preservation for socket preservation |
| Socket Preservation by icecream cone techniqueCollagen barrier membrane will be shaped as an ice cream cone and placed in the extraction socket lining the buccal tissues. The socket will be filled with Demineralized Bovine Bone Matrix DBBM.The upper part of the membrane will be used to cover the socket and will be stabilized by interrupted sutures using prolene sutures of size 6-0 | Procedure or surgery | ice cream cone technique for socket preservation |
Primary outcome
Linear buccal distance (mm)
Time frame: 6 months
Soft tissue linear buccal distance will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark)
4 secondary outcomes
Changes in the height of the socket buccal and palatal ridges (mm)
Time frame: 6 months
Labiopalatal volumetric ridge contour analysis (mm)
Time frame: 6 months
Patient satisfaction (Yes/No)
Time frame: 2 weeks
Pain (1-10)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Socket Shield
Recruiting
Guided Root Slice Replantation vs. Socket Shielding for Immediate Implant Placement in Esthetic Zone
TEETH EXTRACTION, Esthetic Zone Implantology
Not yet recruiting
Multicenter Clinical Study on the Efficacy and Esthetic Outcomes of Immediate Implant Placement Using the Socket-Shield Technique Versus Conventional Immediate Implantation in the Anterior Maxillary Esthetic Zone
Teeth Absent, Teeth Missing
Active, not recruiting
Effect of Subepithelial Connective Tissue Graft With Socket Shield Technique
Socket Shield Technique Implant Placement, Immediate Implant Placement
Recruiting
Comparison Between Socket Shield and Conventional Techniques in Immediate Implant Placement.
Bone Density, Bone Level
Not yet recruiting
Supracrestal Socket Shield Technique in Anterior Maxilla. A Case Series
Immediate Dental Implant Placement, Anterior Maxilla
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 Preservation by vestibular socket therapy and Socket Preservation by icecream cone technique in people with Socket Shield and Socket Preservation, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 25 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Linear buccal distance (mm) (time frame: 6 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 25 Apr 2025.