Socket PreservationPhase 4NCT06707909
The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation
A Phase 4 study testing Menaquinone in people with Socket Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
This study is a randomized controlled trial comparing the effects of socket grafting with crushed vitamin K2 (menaquinone)capsules versus no grafting on bone density and socket dimensions following tooth extraction. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- Menaquinone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2025to 24 Nov 2025
- Phase
- Phase 4
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- • Patients with systemic conditions affecting bone metabolism.
- Allergies or sensitivities to hydroxyapatite or Vitamin K2
- Untreated or residual periodontal disease;
- Uncontrolled diabetes (HbA1c > 7.5%);
- Head and/or neck radiotherapy
- Immunosuppressive therapy
Show all 10Show fewer
- Pregnant or nursing
- Substance abuse
- Treated or under treatment with intravenous amino-bisphosphonates
- Patients participating in other studies, if the present protocol could not be properly followed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
mohamed Khashaba, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo
Cairo, Cairo Governorate
mohamed elsawaf, BDS, 01124145951, mohamed.elsawaf@dentistry.cu.edu.eg
About this study
Official title: The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation of Mandibular Single Rooted Teeth Randomized Clinical Trail
This study is a randomized controlled trial comparing the effects of socket grafting with crushed vitamin K2 (menaquinone)capsules versus no grafting on bone density and socket dimensions following tooth extraction. Patients are randomly assigned to one of two groups:
Study Group (Group I): Patients receive socket grafting with crushed vitamin K2 (menaquinone) capsules. The socket is covered with an absorbent sponge, and non-resorbable sutures are placed to stabilize the graft material and achieve soft tissue stability.
Read more
Control Group (Group II): Patients undergo socket healing without grafting. The socket is covered with an absorbent sponge, and non-resorbable sutures are placed over it.
Outcome measures include bone socket dimensions evaluated immediately after extraction with graft material, as well as assessment after 4 months using cone beam computed tomography (CBCT) radiographs. Additionally, core biopsies are taken at the time of implant placement.
Read the detailed description
The study is designed as a randomized controlled trial to investigate the effects of socket grafting with crushed vitamin K2 (menaquinone) capsules compared to no grafting on bone density and socket dimensions following tooth extraction.
Participants: Patients scheduled for tooth extraction are enrolled in the study and randomized into two equal groups.
- Interventions
- Patients were randomly divided into two equal groups.
In both groups:
Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline.
Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken.
In group I (study): the socket will be filled with crushed capsule of vitamin k211. Interventions
- Patients were randomly divided into two equal groups.
In both groups:
Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline.
Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken.
In group I (study): the socket will be filled with crushed capsule of vitamin k2 and cover with an absorbent sponge a Figure of eight tension-free non-resorbable 3-0 sutures will be placed over the filled socket to stabilize the graft material in the socket and to achieve soft tissue stability.
in group II (control): the socket will be left to heal without grafting, and it will be covered with an absorbent sponge. A figure-of-eight tension-free non-resorbable 3-0 sutures will be placed over the socket.
and cover with an absorbent sponge a Figure of eight tension-free non-resorbable 3-0 sutures will be placed over the filled socket to stabilize the graft material in the socket and to achieve soft tissue stability.
in group II (control): the socket will be left to heal without grafting, and it will be covered with an absorbent sponge. A figure-of-eight tension-free non-resorbable 3-0 sutures will be placed over the socket.
- Conditions
- Socket Preservation
- Being tested
- Menaquinone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenaquinoneDrug
Also called vitamin k2 (Menaquinone)
the socket will be filled with crushed capsule of vitamin k2 menaquinone in study group
| Study group | Role | What they receive |
|---|---|---|
| Menaquinone group | Active comparator | Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline. the socket will be filled with crushed capsule of vitamin k2(menaquinone) and cover with an absorbent sponge a Figure of eight tension-free non-resorbable 3-0 sutures will be placed over the filled socket to stabilize the graft material in the socket and to achieve soft tissue stability.
Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken for histomorphometric analysis. Receives: Drug: Menaquinone |
| control group | No intervention | Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline. the socket will be left to heal without grafting, and it will be covered with an absorbent sponge. A figure-of-eight tension-free non-resorbable 3-0 sutures will be placed over the socket. Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken for histomorphometric analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
At the time of extraction, CBCT imaging will provide baseline data on the initial bone structure This baseline measurement serves as a reference point for evaluating any subsequent changes in bone density and morphology.
After four months, another CBCT scan will be conducted to assess the amount of marginal bone loss that has occurred since the initial extraction. By comparing the post-extraction CBCT images with those taken after four months, researchers can quantify any changes in bone volume and identify any areas of concern related to bone resorption. The unit of measurement for the primary outcome, vertical bone change (socket height), is millimeters (mm).
Measured: baseline and 4 month after extraction
Secondary outcomes (2)
Primary stability
For the primary stability assessment, the Implant Stability Quotient (ISQ) will be utilized. ISQ is a non-invasive and widely used method for evaluating the initial stability of dental implants during placement. Unit of Measurement: Implant Stability Quotient (ISQ)
Measured: at time of implant placment
amount of new bone formation
amount of new bone formation," histomorphometric analysis will be employed. This method involves the microscopic examination and quantification of bone tissue characteristics to assess the extent of bone formation.
Histomorphometric analysis allows researchers to evaluate the quality and quantity of newly formed bone in the extraction site or implantation site. It involves taking tissue samples (biopsies) from the area of interest and then processing these samples for microscopic examination. Unit of Measurement: Bone area percentage (%)
Measured: baseline and 4 month after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Feb 2025 (estimated)
- Primary completion25 Oct 2025 (estimated)
- Study completion24 Nov 2025 (estimated)
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hussien Mohamed Elsawaf, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707909
- Sponsor's protocol ID
- CEBD-CU
- Status last verified
- Feb 2025
- First submitted
- 21 Nov 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation of Mandibular Single Rooted Teeth Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT06707909
- Acronym / sponsor ID
- CEBD-CU
- Conditions
- Socket Preservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 24 Nov 2025 (estimated)
- First posted
- 27 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.
This study is a randomized controlled trial comparing the effects of socket grafting with crushed vitamin K2 (menaquinone)capsules versus no grafting on bone density and socket dimensions following tooth extraction. Patients are randomly assigned to one of two groups:
Study Group (Group I): Patients receive socket grafting with crushed vitamin K2 (menaquinone) capsules. The socket is covered with an absorbent sponge, and non-resorbable sutures are placed to stabilize the graft material and achieve soft tissue stability.
Control Group (Group II): Patients undergo socket healing without grafting. The socket is covered with an absorbent sponge, and non-resorbable sutures are placed over it.
Outcome measures include bone socket dimensions evaluated immediately after extraction with graft material, as well as assessment after 4 months using cone beam computed tomography (CBCT) radiographs. Additionally, core biopsies are taken at the time of implant placement.
Detailed description
The study is designed as a randomized controlled trial to investigate the effects of socket grafting with crushed vitamin K2 (menaquinone) capsules compared to no grafting on bone density and socket dimensions following tooth extraction.
Participants: Patients scheduled for tooth extraction are enrolled in the study and randomized into two equal groups.
- Interventions
- Patients were randomly divided into two equal groups.
In both groups:
Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline.
Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken.
In group I (study): the socket will be filled with crushed capsule of vitamin k211. Interventions
- Patients were randomly divided into two equal groups.
In both groups:
Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline.
Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken.
In group I (study): the socket will be filled with crushed capsule of vitamin k2 and cover with an absorbent sponge a Figure of eight tension-free non-resorbable 3-0 sutures will be placed over the filled socket to stabilize the graft material in the socket and to achieve soft tissue stability.
in group II (control): the socket will be left to heal without grafting, and it will be covered with an absorbent sponge. A figure-of-eight tension-free non-resorbable 3-0 sutures will be placed over the socket.
and cover with an absorbent sponge a Figure of eight tension-free non-resorbable 3-0 sutures will be placed over the filled socket to stabilize the graft material in the socket and to achieve soft tissue stability.
in group II (control): the socket will be left to heal without grafting, and it will be covered with an absorbent sponge. A figure-of-eight tension-free non-resorbable 3-0 sutures will be placed over the socket.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menaquinone group | Active comparator | Drug: MenaquinoneTooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline. the socket will be filled with crushed capsule of vitamin k2(menaquinone) and cover with an absorbent sponge a Figure of eight tension-free non-resorbable 3-0 sutures will be placed over the filled socket to stabilize the graft material in the socket and to achieve soft tissue stability. Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken for histomorphometric analysis. |
| control group | No intervention | –Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline. the socket will be left to heal without grafting, and it will be covered with an absorbent sponge. A figure-of-eight tension-free non-resorbable 3-0 sutures will be placed over the socket. Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken for histomorphometric analysis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- • Patients with systemic conditions affecting bone metabolism.
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 |
|---|---|---|
| MenaquinoneAlso: vitamin k2 (Menaquinone)the socket will be filled with crushed capsule of vitamin k2 menaquinone in study group | Drug | Menaquinone group |
Primary outcome
Marginal bone loss
Time frame: baseline and 4 month after extraction
At the time of extraction, CBCT imaging will provide baseline data on the initial bone structure This baseline measurement serves as a reference point for evaluating any subsequent changes in bone density and morphology. After four months, another CBCT scan will be conducted to assess the amount of marginal bone loss that has occurred since the initial extraction. By comparing the post-extraction CBCT images with those taken after four months, researchers can quantify any changes in bone volume and identify any areas of concern related to bone resorption. The unit of measurement for the primary outcome, vertical bone change (socket height), is millimeters (mm).
2 secondary outcomes
Primary stability
Time frame: at time of implant placment
amount of new bone formation
Time frame: baseline and 4 month after extraction
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 5 Feb 2025.
Related trials for Socket Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Recruiting
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
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.
mohamed Khashaba, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Menaquinone in people with 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 0 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 mohamed elsawaf, BDS (01124145951, mohamed.elsawaf@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (time frame: baseline and 4 month after extraction). 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 5 Feb 2025.