Tooth ExtractionNCT07595445
Injectable Alloplastic Bone Graft for Socket Preservation: Clinical, Radiographic, and Histological Evaluation
A study testing Injectable Alloplastic Bone and natural healing (no graft) in people with Tooth Extraction and Socket Preservation, run by Suez Canal University.
Trial summary
This study will evaluate the clinical efficacy of injectable alloplastic bone grafts in terms of radiography and histology in order to preserve tooth sockets following extraction. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Tooth Extraction, Socket Preservation
- What is being tested?
- Injectable Alloplastic Bone and natural healing (no graft)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Nov 2026
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient aged between 40 and 60 years.
- General good health.
- Presence of a hopeless mandibular posterior tooth that requires extraction.
- Volunteer subjects have to voluntarily sign an informed consent.
- Patient Indicated for implant.
Who cannot join
- Patient with systemic disease affection bone metabolism.
- Large periapical radiographic changes related to the tooth to be Extracted, in the form of abscess, granuloma, or cyst.
- Teeth need trans-alveolar extraction.
- Patients with contraindication to surgical treatment.
- Patients suffering from a psychological disorder.
- Patients with uncontrolled medical conditions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical, Radiographic, and Histological Evaluation of Injectable Alloplastic Bone Graft in Extraction Socket Preservation
This study will evaluate the clinical efficacy of injectable alloplastic bone grafts in terms of radiography and histology in order to preserve tooth sockets following extraction. Methodology: Twenty new extraction sockets from twenty surgically extracted non-restorable mandibular molar teeth will be used in this clinical investigation.
Read the detailed description
Using computer randomization (http://www.randomlists.com), the 20 extraction sockets will be split into two equal groups (n=10) at random. Ten sockets (the experimental group) will undergo socket preservation using injectable bone substitute biomaterial. To permit normal physiological healing, the remaining 10 sockets (control group) will left unfilled. Clinical examination will be carried out after 2 days, 1 week, 2 weeks, 1 month, and 4 months, while after 4 months, radiographic measurements of bone dimension changes were carried out, and the histological inspection will be carried out three months after the removal of the tooth.
- Conditions
- Tooth Extraction, Socket Preservation
- Being tested
- Injectable Alloplastic Bone, natural healing (no graft)
- Keywords
- Injectable Alloplastic Bone Graft, Socket Preservation, Bone Regeneration, Clinical Evaluation, Radiographic Evaluation, Histological Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Alloplastic BoneProcedure or surgery
Ten extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage.
natural healing (no graft)Procedure or surgery
Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing.
| Study group | Role | What they receive |
|---|---|---|
| the experimental group (IBS group) | Experimental | Ten extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage. Receives: Procedure: Injectable Alloplastic Bone |
| control group (natural healing) | Active comparator | Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing. Receives: Procedure: natural healing (no graft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in buccolingual ridge width assessed by CBCT
Buccolingual ridge width will be measured radiographically using CBCT immediately post-extraction (baseline) and after 4 months
Measured: Baseline and 4 months
Bone density assessed by CBCT
Bone density of the extraction socket will be evaluated radiographically using CBCT gray values immediately post-extraction (baseline) and after 4 months.
Measured: Baseline and 4 months
Percentage of newly formed bone assessed histomorphometrically
The percentage of newly formed bone will be evaluated histomorphometrically using hematoxylin and eosin staining during implant placement.
Measured: 3 months
Percentage of residual graft material
Residual graft material percentage will be assessed histomorphometrically using hematoxylin and eosin staining during implant placement.
Measured: 3 months
Percentage of connective tissue
Connective tissue percentage will be assessed histomorphometrically using hematoxylin and eosin staining during implant placement.
Measured: 3 months
Secondary outcomes (1)
Mucosal healing
Clinical mucosal healing will be assessed by the presence or absence of infection, swelling, and adverse tissue reaction during follow-up visits.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- dr mohamed elsholkamy el sholkamy, Professor, Study director, Suez Canal Universitymoataz mohsen zaki, master, Principal investigator, Suez Canal UniversityDr merihan nabih elmansy, Study director, Suez Canal Universitydr ahmed abdelmohsen younis, Study director, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595445
- Sponsor's protocol ID
- Surgery-Bone-01
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic, and Histological Evaluation of Injectable Alloplastic Bone Graft in Extraction Socket Preservation
- ClinicalTrials.gov ID
- NCT07595445
- Acronym / sponsor ID
- Surgery-Bone-01
- Conditions
- Tooth Extraction, Socket Preservation
- Keywords
- Injectable Alloplastic Bone Graft, Socket Preservation, Bone Regeneration, Clinical Evaluation, Radiographic Evaluation, Histological Evaluation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 May 2026 (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.
This study will evaluate the clinical efficacy of injectable alloplastic bone grafts in terms of radiography and histology in order to preserve tooth sockets following extraction. Methodology: Twenty new extraction sockets from twenty surgically extracted non-restorable mandibular molar teeth will be used in this clinical investigation.
Detailed description
Using computer randomization (http://www.randomlists.com), the 20 extraction sockets will be split into two equal groups (n=10) at random. Ten sockets (the experimental group) will undergo socket preservation using injectable bone substitute biomaterial. To permit normal physiological healing, the remaining 10 sockets (control group) will left unfilled. Clinical examination will be carried out after 2 days, 1 week, 2 weeks, 1 month, and 4 months, while after 4 months, radiographic measurements of bone dimension changes were carried out, and the histological inspection will be carried out three months after the removal of the tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group (IBS group) | Experimental | Procedure: Injectable Alloplastic BoneTen extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage. |
| control group (natural healing) | Active comparator | Procedure: natural healing (no graft)Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient aged between 40 and 60 years.
- General good health.
- Presence of a hopeless mandibular posterior tooth that requires extraction.
- Volunteer subjects have to voluntarily sign an informed consent.
- Patient Indicated for implant.
Key exclusion criteria (6 listed)
- Patient with systemic disease affection bone metabolism.
- Large periapical radiographic changes related to the tooth to be Extracted, in the form of abscess, granuloma, or cyst.
- Teeth need trans-alveolar extraction.
- Patients with contraindication to surgical treatment.
- Patients suffering from a psychological disorder.
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 |
|---|---|---|
| Injectable Alloplastic BoneTen extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage. | Procedure or surgery | the experimental group (IBS group) |
| natural healing (no graft)Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing. | Procedure or surgery | control group (natural healing) |
Primary outcome
Change in buccolingual ridge width assessed by CBCT
Time frame: Baseline and 4 months
Buccolingual ridge width will be measured radiographically using CBCT immediately post-extraction (baseline) and after 4 months
Bone density assessed by CBCT
Time frame: Baseline and 4 months
Bone density of the extraction socket will be evaluated radiographically using CBCT gray values immediately post-extraction (baseline) and after 4 months.
Percentage of newly formed bone assessed histomorphometrically
Time frame: 3 months
The percentage of newly formed bone will be evaluated histomorphometrically using hematoxylin and eosin staining during implant placement.
Percentage of residual graft material
Time frame: 3 months
Residual graft material percentage will be assessed histomorphometrically using hematoxylin and eosin staining during implant placement.
Percentage of connective tissue
Time frame: 3 months
Connective tissue percentage will be assessed histomorphometrically using hematoxylin and eosin staining during implant placement.
1 secondary outcome
Mucosal healing
Time frame: Up to 4 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 19 May 2026.
- 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.
dr mohamed elsholkamy el sholkamy, Professor study director
Suez Canal University
moataz mohsen zaki, master principal investigator
Suez Canal University
Dr merihan nabih elmansy study director
Suez Canal University
Questions about this trial
What is this clinical trial studying?
A study testing Injectable Alloplastic Bone and natural healing (no graft) in people with Tooth Extraction and Socket Preservation, run by Suez Canal University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Moataz Selmi (01006848382, moatazselmi93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in buccolingual ridge width assessed by CBCT (time frame: Baseline and 4 months). The study lists 5 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 19 May 2026.