Socket PreservationNCT07250256
Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth.
A study testing S1-XB in people with Socket Preservation, run by Suez Canal University at 1 site in Egypt.
Trial summary
Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth: A Randomized-Controlled Clinical Study Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- S1-XB
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Dec 2024
- 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 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients aged between 21 and 40 years.
- General good health.
- Absence of any relevant systemic disease.
- Presence of a hopeless maxillary posterior tooth that requires extraction.
- Extraction site suitable for replacement by a dental implant.
- Cases have adequate bone width and length.
- Volunteer subjects must sign an informed consent.
Who cannot join
- Poor oral hygiene with no possibility of improvement.
- Smokers (more than 10 cigarettes per day).
- Chronic treatment with any medication known to affect oral status and bone turnover.
- Drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth: A Randomized-Controlled Clinical Study
Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth: A Randomized-Controlled Clinical Study
Read the detailed description
The process of natural healing starts with new bone formation taking place from initial islands of bone within the connective tissue occurring after a 4 to 8 weeks interval from extraction date. This is followed by the manifestation of a mature trabecular structure that can be noticed at 10 to 20 weeks after extraction accompanied with a reduction in osteoblast count. As a result of the extensive bone resorption post extraction, the prosthetically driven implant placement is compromised and in need of some ridge preservation techniques that have been widely studied to try and ensure less alveolar bone loss. The aim of this research is to study the S1-XB Xenograft containing hydrogel and to evaluate its effects on extraction socket healing in comparison to natural socket healing. This is an In-Vivo comparative randomized controlled study that will be conducted on patients of the outpatient clinic of Oral and Maxillofacial department Suez Canal University to evaluate the difference between using S1-XB bone graft as a socket preservation material and normal socket healing without adding any socket preservation materials.
- Conditions
- Socket Preservation
- Being tested
- S1-XB, Control (Standard treatment)
- Keywords
- Socket, Healing, bone formation, histomorphometery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1-XBDevice
Socket grafted with xenograft containing alginate hydrogel material
Control (Standard treatment)Procedure or surgery
Atraumatic extraction and sockets were allowed to undergo normal healing without any graft materials
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | (8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction. Receives: Device: S1-XB |
| Control group | Placebo comparator | (8 cases): was not exposed to any type of socket preservation after the extraction procedure. Receives: Procedure: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric analysis
Samples were first stained with hematoxylin and eosin (H\&E) to demonstrate the general tissue architecture, cellular distribution, and overall structural organization. Subsequently, sections were stained with Masson's Trichrome (MTC) to allow both qualitative and quantitative assessment of bone trabeculae and osteoid tissue. Osteopontin (OPN) immunohistochemistry was used to assess the percentage of OPN expression area within the surrounding connective tissue. The OPN poly-colonal antibody was purchased from Thermo Fisher Scientific, Catalog # PA1-72061. Images were captured at ×400 magnification using a SOPTOP EX20 microscope with HD camera. ImageJ software was used to quantify area% from five standardized fields per section at oral pathology laboratory, Faculty of Dentistry, Suez Canal University.
Measured: 16 weeks
Radiographic evaluation
Cone-beam computed tomography (CBCT) scans (Scanora 3D) were obtained immediately after extraction at baseline and postponed at 4 months postoperatively to evaluate the following parameters: bone density that was measured in Hounsfield units (HU) at the center of the socket, ridge height that was determined by vertical distance from the crestal bone to a fixed reference point and ridge width that was measured at 3 mm apical to the crest.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Aug 2022
- Primary completion1 Aug 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket PreservationStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Model description
- This is an In-Vivo comparative randomized controlled study that will be conducted on patients of the outpatient clinic of Oral and Maxillofacial department Suez Canal University to evaluate the difference between using S1-XB bone graft as a socket preservation material and normal socket healing without adding any socket preservation materials.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250256
- Sponsor's protocol ID
- 547-2022
- Status last verified
- Nov 2025
- First submitted
- 16 Aug 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth: A Randomized-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07250256
- Acronym / sponsor ID
- 547-2022
- Conditions
- Socket Preservation
- Keywords
- Socket, Healing, bone formation, histomorphometery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 26 Nov 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.
Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth: A Randomized-Controlled Clinical Study
Detailed description
The process of natural healing starts with new bone formation taking place from initial islands of bone within the connective tissue occurring after a 4 to 8 weeks interval from extraction date. This is followed by the manifestation of a mature trabecular structure that can be noticed at 10 to 20 weeks after extraction accompanied with a reduction in osteoblast count. As a result of the extensive bone resorption post extraction, the prosthetically driven implant placement is compromised and in need of some ridge preservation techniques that have been widely studied to try and ensure less alveolar bone loss. The aim of this research is to study the S1-XB Xenograft containing hydrogel and to evaluate its effects on extraction socket healing in comparison to natural socket healing. This is an In-Vivo comparative randomized controlled study that will be conducted on patients of the outpatient clinic of Oral and Maxillofacial department Suez Canal University to evaluate the difference between using S1-XB bone graft as a socket preservation material and normal socket healing without adding any socket preservation materials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an In-Vivo comparative randomized controlled study that will be conducted on patients of the outpatient clinic of Oral and Maxillofacial department Suez Canal University to evaluate the difference between using S1-XB bone graft as a socket preservation material and normal socket healing without adding any socket preservation materials.
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Device: S1-XB(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction. |
| Control group | Placebo comparator | Procedure: Control (Standard treatment)(8 cases): was not exposed to any type of socket preservation after the extraction procedure. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male patients aged between 21 and 40 years.
- General good health.
- Absence of any relevant systemic disease.
- Presence of a hopeless maxillary posterior tooth that requires extraction.
- Extraction site suitable for replacement by a dental implant.
Key exclusion criteria (4 listed)
- Poor oral hygiene with no possibility of improvement.
- Smokers (more than 10 cigarettes per day).
- Chronic treatment with any medication known to affect oral status and bone turnover.
- Drug or alcohol abuse.
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 |
|---|---|---|
| S1-XBSocket grafted with xenograft containing alginate hydrogel material | Device | Study group |
| Control (Standard treatment)Atraumatic extraction and sockets were allowed to undergo normal healing without any graft materials | Procedure or surgery | Control group |
Primary outcome
Histomorphometric analysis
Time frame: 16 weeks
Samples were first stained with hematoxylin and eosin (H\&E) to demonstrate the general tissue architecture, cellular distribution, and overall structural organization. Subsequently, sections were stained with Masson's Trichrome (MTC) to allow both qualitative and quantitative assessment of bone trabeculae and osteoid tissue. Osteopontin (OPN) immunohistochemistry was used to assess the percentage of OPN expression area within the surrounding connective tissue. The OPN poly-colonal antibody was purchased from Thermo Fisher Scientific, Catalog # PA1-72061. Images were captured at ×400 magnification using a SOPTOP EX20 microscope with HD camera. ImageJ software was used to quantify area% from five standardized fields per section at oral pathology laboratory, Faculty of Dentistry, Suez Canal University.
Radiographic evaluation
Time frame: 16 weeks
Cone-beam computed tomography (CBCT) scans (Scanora 3D) were obtained immediately after extraction at baseline and postponed at 4 months postoperatively to evaluate the following parameters: bone density that was measured in Hounsfield units (HU) at the center of the socket, ridge height that was determined by vertical distance from the crestal bone to a fixed reference point and ridge width that was measured at 3 mm apical to the crest.
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 26 Nov 2025.
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Biotivity A-C Membrane Socket Preservation Study
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Vallomix Socket Preservation Study
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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 S1-XB in people with Socket Preservation, run by Suez Canal 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 7 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: finished, as of the sponsor's last update on 26 Nov 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. Some participants in this study may receive a placebo. 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?
Histomorphometric analysis (time frame: 16 weeks). 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 26 Nov 2025.